Effects of Calcium Supplementation on Women in the Curves for Women Program

March 15, 2019 updated by: Richard B. Kreider, Texas A&M University

Effects of Calcium Supplementation on Body Composition, Metabolism and Exercise Capacity in Post-Menopausal Women Participating in the Curves for Women Fitness and Weight Loss Program

The purpose of this study is to examine the effects of dietary calcium supplementation on weight loss, bone density, and markers of health and fitness in women participating in the Curves exercise and diet program.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The Curves International fitness and weight loss program has become a very popular means of promoting health and fitness among women. The program involves a 30-minute circuit training program and a weight management program involving periods of moderate caloric restriction (1,200 to 1,600 calories per day) followed by short periods of higher caloric intake (2,600 calories per day). The program is designed to promote a gradual reduction in body fat while increasing strength and muscle mass/tone. Researchers in the Exercise & Sport Nutrition Lab at Texas A&M University have conducted an extensive study on the effectiveness and safety of the Curves fitness and diet program. Results of this initial study have shown that the program promotes weight loss, improves markers of health, and improves fitness. However, we feel that the program may be even more effective with some additional nutritional interventions. Calcium has been shown to slow bone loss and more recently has been found to help promote fat loss. If this is the case, supplementing the diet with calcium may promote greater benefits in women participating in the Curves fitness/diet program. The purpose of this study is to examine the effect of dietary calcium supplementation on weight loss, bone density, and markers of health and fitness in women participating in the Curves exercise and diet program.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Participant is female;
  • Participant is post-menopausal;
  • Participant is between the ages of 45 and 65;
  • Participant is sedentary, overweight (BMI > 27) and post-menopausal;

Exclusion Criteria:

  • Participant has any metabolic disorder including known electrolyte abnormalities, heart disease, arrhythmias, diabetes, or thyroid disease;
  • Participant has a history of hypertension, hepatorenal, musculoskeletal, autoimmune or neurological disease;
  • Participant is taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive or androgenic medications;
  • Participant has taken ergogenic levels of nutritional supplements that may affect muscle mass (i.g., creatine, HMB, etc.), anabolic/catabolic hormone levels (i.e., androstenedione, DHEA, etc.) or weight loss (i.e., ephedra, thermogenics, etc.) within three months prior to the start of the study;
  • Participant is consistently taking 500 mg or more of a Calcium supplement per day;
  • Participant is receiving Hormone Replacement Therapy (HRT);
  • Participant is involved in a planned exercise program within 3 - 6 months prior to the start of the study;
  • Participant has lost > 20 lbs. within the last 3 - 6 months;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: No Diet
No diet or exercise or calcium intervention
Dietary supplement: Placebo
Dextrose placebo
Dietary supplement: Curves Calcium
Curves Essential Bio-Available Calcium (providing 800 mg/d of calcium [as calcium citrate malate and calcium citrate], 400 IU/d of Vitamin D, 300 mg/d of magnesium, 4 mg/d of zinc, 2 mg/d of copper, 2 mg/d of manganese, 198 mg/d of potassium, 100 mg/d of trace mineral complex, and 2 mg/d of boron).
Dietary supplement: Calcium Carbonate
Calcium (providing 950 mg/d as carbonate)
Experimental: High Calorie Diet
High calorie (2,600 calorie) diet and exercise and calcium
Dietary supplement: Placebo
Dextrose placebo
Dietary supplement: Curves Calcium
Curves Essential Bio-Available Calcium (providing 800 mg/d of calcium [as calcium citrate malate and calcium citrate], 400 IU/d of Vitamin D, 300 mg/d of magnesium, 4 mg/d of zinc, 2 mg/d of copper, 2 mg/d of manganese, 198 mg/d of potassium, 100 mg/d of trace mineral complex, and 2 mg/d of boron).
Dietary supplement: Calcium Carbonate
Calcium (providing 950 mg/d as carbonate)
Experimental: Low Carbohydrate/High Protein Diet
Low carbohydrate (63% protein, 7% carbohydrate, 30% fat) diet and exercise and calcium
Dietary supplement: Placebo
Dextrose placebo
Dietary supplement: Curves Calcium
Curves Essential Bio-Available Calcium (providing 800 mg/d of calcium [as calcium citrate malate and calcium citrate], 400 IU/d of Vitamin D, 300 mg/d of magnesium, 4 mg/d of zinc, 2 mg/d of copper, 2 mg/d of manganese, 198 mg/d of potassium, 100 mg/d of trace mineral complex, and 2 mg/d of boron).
Dietary supplement: Calcium Carbonate
Calcium (providing 950 mg/d as carbonate)
Experimental: High Carbohydrate/Low Protein
High carbohydrate (15% protein, 55% carbohydrate, 30% fat) diet and exercise and calcium
Dietary supplement: Placebo
Dextrose placebo
Dietary supplement: Curves Calcium
Curves Essential Bio-Available Calcium (providing 800 mg/d of calcium [as calcium citrate malate and calcium citrate], 400 IU/d of Vitamin D, 300 mg/d of magnesium, 4 mg/d of zinc, 2 mg/d of copper, 2 mg/d of manganese, 198 mg/d of potassium, 100 mg/d of trace mineral complex, and 2 mg/d of boron).
Dietary supplement: Calcium Carbonate
Calcium (providing 950 mg/d as carbonate)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Body Composition: Body Fat
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in body composition (% body fat) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Body Composition: Fat Free Mass
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in body composition (fat free mass) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Body Composition: Bone Mass
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in body composition (bone mass) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Body Composition: Fat Mass
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in body composition (fat mass) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Body Composition: Lean Mass
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in body composition (lean mass) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Body Composition: Body Weight
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in body weight (lbs. body weight) obtained via digital scale and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Energy Homeostasis: Resting Energy Expenditure (REE)
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in REE obtained via metabolic cart and expressed in absolute (kcals/d) and relative terms (kcals/kg/d) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Energy Homeostasis: Respiratory Exchange Ratio (RER)
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in RER as an indicator of carbohydrate and fat oxidation analyzed with related resting energy expenditure outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Muscular Strength: 1 Repetition Maximum (1RM) Bench Press
Time Frame: Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
Changes in bench press 1RM obtained from a bench press test and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
Muscular Strength: 1 Repetition Maximum (1RM) Leg Press
Time Frame: Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
Changes in leg press 1RM obtained from a leg press test and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
Muscular Endurance: 80% of 1 Repetition Maximum (1RM) Bench Press Endurance Test
Time Frame: Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
Changes in total repetitions at 80% of 1RM obtained from a bench press test and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
Muscular Endurance: 80% of 1 Repetition Maximum (1RM) Leg Press Endurance Test
Time Frame: Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
Changes in total repetitions at 80% of 1RM obtained from a leg press test and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
Body Composition: Body Water
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in body water obtained via Bioelectrical Impedance Analysis (BIA) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Lipid Panel: Cholesterol
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in cholesterol obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Lipid Panel: HDL Cholesterol
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in HDL cholesterol obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Lipid Panel: LDL Cholesterol
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in LDL cholesterol obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Lipid Panel: Triglycerides
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in triglycerides obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Glucose
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in glucose obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Calcium
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in calcium obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Albumin
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in albumin obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Total Protein
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in total protein obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Sodium
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in sodium obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Potassium
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in potassium obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Carbon Dioxide (CO2)
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in carbon dioxide (CO2) obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Chloride
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in chloride obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Blood Urea Nitrogen (BUN)
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in blood urea nitrogen (BUN) obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Creatinine
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in creatinine obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Alkaline Phosphatase (ALP)
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in alkaline phosphatase (ALP) obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Amino Transferase (ALT)
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in alanine amino transferase (ALT) obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Amino Transferase (AST)
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in alanine amino transferase (ALT) obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Bilirubin
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in bilirubin obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: White Blood Cell (WBC) Count
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in white blood cell count (WBC) obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: White Blood Cell Differential
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in white blood cell differential obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Red Blood Cell (RBC) Count
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in red blood cell count obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Red Cell Distribution Width (RDW)
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in red cell distribution width (RDW) obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Hemoglobin
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in hemoglobin obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Hematocrit
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in hematocrit obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Platelet Count
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in platelet count obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Mean Platelet Volume (MPV)
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in mean platelet volume (MPV) obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Neutrophils
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in neutrophils obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Lymphocytes
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in lymphocytes obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Basophils
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in basophils obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Eosinophils
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in eosinophils obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Monocytes
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in monocytes obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Mean Corpuscular Volume (MCV)
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in mean corpuscular volume (MCV) obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Mean Corpuscular Hemoglobin (MCH)
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in mean corpuscular hemoglobin (MCH) obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Mean Corpuscular Hemoglobin Concentration (MCHC)
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in mean corpuscular hemoglobin concentration (MCHC) obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Hormones: Insulin
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in serum insulin obtained from venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Hormones: Leptin
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in serum leptin obtained from venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Hemodynamic Variable: Resting Heart Rate (HR)
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in resting heart rate (HR) obtained via a blood pressure meter and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Hemodynamic Variable: Resting Systolic Blood Pressure (SBP)
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in resting systolic blood pressure (mmHg) analyzed with related resting hemodynamic outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Hemodynamic Variable: Resting Diastolic Blood Pressure (DBP)
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in resting diastolic blood pressure (mmHg) analyzed with related resting hemodynamic outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Anthropometric Measures: Waist Circumference
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in waist circumference obtained via tape measure and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Anthropometric Measures: Hip Circumference
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in hip circumference obtained via tape measure and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Anthropometric Measures: Waist to Hip Ratio
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in the ratio of waist to hip (waist/hip circumference) analyzed with related anthropometric outcomes measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Anthropometric Measures: Body Mass Index
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Change in body mass index (kg of body mass/height in meters squared) analyzed with related anthropometric outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Cardiac Variable: Resting Electrocardiogram (ECG)
Time Frame: Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
Changes in resting ECG obtained via electrodes and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
Exercise Capacity: Graded Exercise Test (GXT)
Time Frame: Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
Changes in exercise capacity obtained via a treadmill test and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
Subjective Rating of Quality of Life
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in Quality of Life (QOL) obtained via SF36v2 questionnaire and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's). The SF-36 QOL inventory provides scores that assess physical functioning (i.e., ability to perform most vigorous physical activities without limitation to health); role physical (i.e., ability to work and perform daily activities); bodily pain (i.e., limitations due to pain); general health (i.e., assessment of personal health); vitality (i.e., feelings of energy); social functioning (i.e., ability to perform normal social activities); role emotion (i.e., problems with work or other daily activities); and, mental health (state of feelings of peacefulness, happiness, and calm) domains on a 0 (low) to 100 (high scale.
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Subjective Rating of Appetite
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
A subjective Likert scale that asked participants to rank the frequency and severity of their symptoms of appetite using the following scale: 0 (none), 1 - 3 (low), 4 - 6 (moderate), 7 - 9 (high), 10 (severe). Data will be analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Subjective Rating of Hunger
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
A subjective Likert scale that asked participants to rank the frequency and severity of their symptoms of hunger using the following scale: 0 (none), 1 - 3 (low), 4 - 6 (moderate), 7 - 9 (high), 10 (severe). Data will be analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Subjective Rating of Satisfaction from Food
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
A subjective Likert scale that asked participants to rank the frequency and severity of their symptoms of satisfaction from food using the following scale: 0 (none), 1 - 3 (low), 4 - 6 (moderate), 7 - 9 (high), 10 (severe). Data will be analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Subjective Rating of Feelings of Fullness
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
A subjective Likert scale that asked participants to rank the frequency and severity of their symptoms of feelings of fullness using the following scale: 0 (none), 1 - 3 (low), 4 - 6 (moderate), 7 - 9 (high), 10 (severe). Data will be analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Subjective Rating of Amount of Energy
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
A subjective Likert scale that asked participants to rank the frequency and severity of their symptoms of amount of energy using the following scale: 0 (none), 1 - 3 (low), 4 - 6 (moderate), 7 - 9 (high), 10 (severe). Data will be analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Subjective Rating of Overall Quality of Diet
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
A subjective Likert scale that asked participants to rank the frequency and severity of their symptoms of overall quality of diet using the following scale: 0 (none), 1 - 3 (low), 4 - 6 (moderate), 7 - 9 (high), 10 (severe). Data will be analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Dietary Energy Intake - Total Caloric Intake
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Change in caloric/energy intake (kcals/day) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Dietary Energy Intake - Carbohydrate
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Change in dietary carbohydrate intake (grams/day and grams/kg/day) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Dietary Energy Intake - Fat
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Change in dietary fat intake (grams/day and grams/kg/day) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Dietary Energy Intake - Protein
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Change in dietary protein intake (grams/day and grams/kg/day) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Perceptions of Side Effects - Dizziness
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Change in perceptions of dizziness using a Likert scale [0 (none), 1 - 4 (light), 5 - 6 (mild), 7 - 9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Perceptions of Side Effects - Headache
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Change in perceptions of headache using a Likert scale [0 (none), 1 - 4 (light), 5 - 6 (mild), 7 - 9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Perceptions of Side Effects - Tachycardia
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Change in perceptions of tachycardia using a Likert scale [0 (none), 1 - 4 (light), 5 - 6 (mild), 7 - 9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Perceptions of Side Effects - Palpitations
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Change in perceptions of palpitations using a Likert scale [0 (none), 1 - 4 (light), 5 - 6 (mild), 7 - 9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Perceptions of Side Effects - Dyspnea
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Change in perceptions of dyspnea using a Likert scale [0 (none), 1 - 4 (light), 5 - 6 (mild), 7 - 9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Perceptions of Side Effects - Nervousness
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Change in perceptions of nervousness using a Likert scale [0 (none), 1 - 4 (light), 5 - 6 (mild), 7 - 9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Perceptions of Side Effects - Blurred Vision
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Change in perceptions of blurred vision using a Likert scale [0 (none), 1 - 4 (light), 5 - 6 (mild), 7 - 9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Perceptions of Side Effects - Other Side Effects
Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Change in perceptions of other side effects using a Likert scale [0 (none), 1 - 4 (light), 5 - 6 (mild), 7 - 9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Texas A&M University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Richard B Kreider, PhD, Texas A&M University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2005

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB2008-0643

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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