An Examination of a Weight Loss Formula on Health (NB14)

September 9, 2019 updated by: Richard B. Kreider, Texas A&M University

An Examination of a Novel Weight Loss Formula on Anthropometry and Indices of Cardiovascular Disease Risk

The aim of this study is to examine a novel weight loss formula with and without common stimulants on anthropometry and indices of cardiovascular disease risk.

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

Obesity remains a problem for overall health and risk for cardiovascular disease worldwide. While dietary modification and increased levels of physical activity remain steadfast recommendations, alternative strategies related to supplementation remain an interest for the general populace and medical communities. A potential objection to the use of dietary supplements is that they often contain stimulants designed to increase metabolism. However, consumers and health practitioners alike are wary of such formulae; hence, the continued investigation of non-stimulant supplements is warranted. Therefore the aim of this study is to examine a novel weight loss formula with and without common stimulants on anthropometry and indices of cardiovascular disease risk.

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.
80

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • College Station, Texas, United States, 77845
        • Exercise & Sport Nutrition Lab - Human Clinical Research Facility

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

30 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body Mass Index (BMI) between 25 and 34.9

Exclusion Criteria:

  • Recent history of weight change (+/- 10 lbs. within the past 3 months)
  • Uncontrolled metabolic disorders
  • Uncontrolled cardiovascular disorders
  • Currently taking prescription medications (birth control is allowed)
  • Currently taking dietary supplements for weight loss
  • Pregnant or plan to become pregnant
  • Have an intolerance to caffeine or other natural stimulants

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.
Experimental: Active with caffeine
Novel formula with caffeine
Dietary supplement: Active with caffeine
Novel formula with caffeine
Active Comparator: Active without caffeine
Novel formula without caffeine
Dietary supplement: Active without caffeine
Novel formula without caffeine
Placebo Comparator: Placebo
Dextrose
Dietary supplement: Placebo
Dextrose placebo

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 - Weight
Time Frame: Measured every 4 weeks for 12 weeks
Changes in body weight (kg) analyzed with related body composition variables via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Body Composition - Fat Mass
Time Frame: Measured every 4 weeks for 12 weeks
Changes in fat mass (kg) analyzed with related body composition variables via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Body Composition - Body Fat Percent
Time Frame: Measured every 4 weeks for 12 weeks
Changes in body fat (%) analyzed with related body composition variables via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 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
Body Composition - Lean Tissue Mass
Time Frame: Measured every 4 weeks for 12 weeks
Change in lean tissue mass (kg) analyzed with related body composition outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Body Composition - Bone Mass
Time Frame: Measured every 4 weeks for 12 weeks
Change in bone mass (g) analyzed with related body composition outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Body Composition - Fat Free Mass
Time Frame: Measured every 4 weeks for 12 weeks
Changes in fat free mass (sum of lean tissue mass and bone mass expressed in kg) analyzed with related body composition variables via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Body Composition - Total Body Water
Time Frame: Measured every 4 weeks for 12 weeks
Change in total body water (L and %) and analyzed with related body composition outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Resting Energy Expenditure - Caloric Expenditure
Time Frame: Measured every 4 weeks for 12 weeks
Change in resting energy expenditure expressed in absolute (kcals/d) and relative terms (kcals/kg/day) and analyzed with related resting energy expenditure outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Resting Energy Expenditure - Respiratory Exchange Ratio
Time Frame: Measured every 4 weeks for 12 weeks
Change in resting respiratory exchange ratio (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 and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Anthropometric Measures - Waist Circumference
Time Frame: Measured every 4 weeks for 12 weeks
Change in waist circumference (cm) analyzed with related anthropometric outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Anthropometric Measures - Hip Circumference
Time Frame: Measured every 4 weeks for 12 weeks
Change in hip circumference (cm) analyzed with related anthropometric outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Anthropometric Measures - Waist to Hip Ratio
Time Frame: Measured every 4 weeks for 12 weeks
Change in the ratio of waist to hip (waist / hip circumference) analyzed with related anthropometric outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Anthropometric Measures - Body Mass Index
Time Frame: Measured every 4 weeks for 12 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 and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Dietary Energy Intake - Total Caloric Intake
Time Frame: Measured every 4 weeks for 12 weeks
Change in caloric/energy intake (kcals/day) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Dietary Energy Intake - Carbohydrate
Time Frame: Measured every 4 weeks for 12 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 and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Dietary Energy Intake - Fat
Time Frame: Measured every 4 weeks for 12 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 and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Dietary Energy Intake - Protein
Time Frame: Measured every 4 weeks for 12 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 and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Resting Hemodynamics - Heart Rate
Time Frame: Measured every 4 weeks for 12 weeks
Changes in resting heart rate (bpm) analyzed with related resting hemodynamic outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Resting Hemodynamics - Systolic Blood Pressure
Time Frame: Measured every 4 weeks for 12 weeks
Changes in resting systolic blood pressure (mmHg) analyzed with related resting hemodynamic outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Resting Hemodynamics - Diastolic Blood Pressure
Time Frame: Measured every 4 weeks for 12 weeks
Changes in resting diastolic blood pressure (mmHg) analyzed with related resting hemodynamic outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Glucose Homeostasis - Blood Glucose
Time Frame: Measured every 4 weeks for 12 weeks
Change in blood glucose (mg/dl) analyzed with related glucose homeostasis blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Glucose Homeostasis - Fasting Insulin
Time Frame: Measured every 4 weeks for 12 weeks
Change in fasting insulin (µIU/mL) analyzed with related glucose homeostasis blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Glucose Homeostasis - Homeostatic Model Assessment of Insulin Resistance
Time Frame: Measured every 4 weeks for 12 weeks
Change in Homeostatic Model Assessment of Insulin Resistance (Fasting insulin x Fasting glucose / 405) analyzed with related glucose homeostasis blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Lipid Profile - Triglyderides
Time Frame: Measured every 4 weeks for 12 weeks
Change in triglycerides (mg/dl) analyzed with related lipid profile blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Lipid Profile - Total Cholesterol
Time Frame: Measured every 4 weeks for 12 weeks
Change in total cholesterol (mg/dl) analyzed with related lipid profile blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Lipid Profile - High Density Lipoproteins
Time Frame: Measured every 4 weeks for 12 weeks
Change in high density lipoproteins (mg/dl) analyzed with related lipid profile blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Lipid Profile - Low Density Lipoproteins
Time Frame: Measured every 4 weeks for 12 weeks
Change in low density lipoproteins (mg/dl) analyzed with related lipid profile blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Lipid Profile - Total Cholesterol to HDL Ratio
Time Frame: Measured every 4 weeks for 12 weeks
Change in the ratio of total cholesterol to high density lipoproteins (HDL) analyzed with related lipid profile blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Catabolic Markers - Creatinine
Time Frame: Measured every 4 weeks for 12 weeks
Change in creatinine (mg/dl) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Catabolic Markers - Blood Urea Nitrogen
Time Frame: Measured every 4 weeks for 12 weeks
Change in blood urea nitrogen (mg/dl) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Catabolic Markers - Blood Urea Nitrogen to Creatinine Ratio
Time Frame: Measured every 4 weeks for 12 weeks
Change in the ratio of blood urea nitrogen (mg/dl) to creatinine (mg/dl) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Catabolic Markers - Alkaline Phosphatase
Time Frame: Measured every 4 weeks for 12 weeks
Change in alkaline phosphatase (IU/L) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Catabolic Markers - Alanine Amino Transaminase
Time Frame: Measured every 4 weeks for 12 weeks
Change in alanine amino transaminase (IU/L) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Catabolic Markers - Aspartate Amino Transaminase
Time Frame: Measured every 4 weeks for 12 weeks
Change in aspartate amino transaminase (IU/L) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Catabolic Markers - Creatine Kinase
Time Frame: Measured every 4 weeks for 12 weeks
Change in creatine kinase (IU/L) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Catabolic Markers - Lactate Dehydrogenase
Time Frame: Measured every 4 weeks for 12 weeks
Change in lactate dehydrogenase (IU/L) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - White Blood Cell Counts - White Blood Cells
Time Frame: Measured every 4 weeks for 12 weeks
Change in white blood cells (K/uL) analyzed with related white blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - White Blood Cell Counts - Lymphocytes
Time Frame: Measured every 4 weeks for 12 weeks
Change in lymphocytes (K/uL) analyzed with related white blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - White Blood Cell Counts - Mid-Range Count
Time Frame: Measured every 4 weeks for 12 weeks
Change in mid-range count (K/uL) analyzed with related white blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - White Blood Cell Counts - Granulocyte
Time Frame: Measured every 4 weeks for 12 weeks
Change in granulocyte count (K/uL) analyzed with related white blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Red Blood Cell Counts - Red Cells
Time Frame: Measured every 4 weeks for 12 weeks
Change in red cell count (M/uL) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Red Blood Cell Counts - Hemoglobin
Time Frame: Measured every 4 weeks for 12 weeks
Change in hemoglobin (g/dl) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Red Blood Cell Counts - Hematocrit
Time Frame: Measured every 4 weeks for 12 weeks
Change in hematocrit (%) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Corpuscular Volume
Time Frame: Measured every 4 weeks for 12 weeks
Change in mean corpuscular volume (fL) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Corpuscular Hemoglobin
Time Frame: Measured every 4 weeks for 12 weeks
Change in mean corpuscular hemoglobin (pg/cell) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Corpuscular Hemoglobin Concentration
Time Frame: Measured every 4 weeks for 12 weeks
Change in mean corpuscular hemoglobin concentration (g/dl) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Red Blood Cell Counts - Red Cell Distribution Width
Time Frame: Measured every 4 weeks for 12 weeks
Change in red cell distribution width (%) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Red Blood Cell Counts - Platelet Count
Time Frame: Measured every 4 weeks for 12 weeks
Change in platelet count (x103/uL) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Platelet Volume
Time Frame: Measured every 4 weeks for 12 weeks
Change in mean platelet volume (fL) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Appetite Hormone - Leptin
Time Frame: Measured every 4 weeks for 12 weeks
Change in leptin levels (ng/ml) analyzed via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
International Physical Activity Questionnaire (IPAQ) - Work Domain
Time Frame: Measured every 4 weeks for 12 weeks
Change in IPAQ work domain (MET minutes/week) analyzed with related IPAQ outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
International Physical Activity Questionnaire (IPAQ) - Active Transportation Domain
Time Frame: Measured every 4 weeks for 12 weeks
Change in IPAQ active transportation domain (MET minutes/week) analyzed with related IPAQ outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
International Physical Activity Questionnaire (IPAQ) - Domestic and Garden/Yard Work Domain
Time Frame: Measured every 4 weeks for 12 weeks
Change in IPAQ domestic and garden/yard work domain (MET minutes/week) analyzed with related IPAQ outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
International Physical Activity Questionnaire (IPAQ) - Leisure-Time Domain
Time Frame: Measured every 4 weeks for 12 weeks
Change in IPAQ leisure-time domain (MET minutes/week) analyzed with related IPAQ outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
International Physical Activity Questionnaire (IPAQ) - Total Physical Activity Score
Time Frame: Measured every 4 weeks for 12 weeks
Change in IPAQ leisure time domain (Total physical activity MET-minutes/week = sum of Total Work + Total Transport + Total Domestic and Garden + Total Leisure-Time MET-minutes/week scores) analyzed with related IPAQ outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Satiety Questionnaire - Perceptions of Appetite
Time Frame: Measured every 4 weeks for 12 weeks
Changes in perceptions of appetite assessed using using a 0 to 10 Likert scale (0 was none, 2.5 was low, 5 was moderate, and 7.5 was high, and 10 was severe) and analyzed with related satiety questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Satiety Questionnaire - Perceptions of Hunger
Time Frame: Measured every 4 weeks for 12 weeks
Changes in perceptions of hunger assessed using using a 0 to 10 Likert scale (0 was none, 2.5 was low, 5 was moderate, and 7.5 was high, and 10 was severe) and analyzed with related satiety questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Satiety Questionnaire - Perceptions of Satisfaction with Food
Time Frame: Measured every 4 weeks for 12 weeks
Changes in perceptions of satisfaction with food assessed using using a 0 to 10 Likert scale (0 was none, 2.5 was low, 5 was moderate, and 7.5 was high, and 10 was severe) and analyzed with related satiety questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Satiety Questionnaire - Perceptions of Feelings of Fullness
Time Frame: Measured every 4 weeks for 12 weeks
Changes in perceptions of feelings of fullness assessed using using a 0 to 10 Likert scale (0 was none, 2.5 was low, 5 was moderate, and 7.5 was high, and 10 was severe) and analyzed with related satiety questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Satiety Questionnaire - Perceptions of Diet / Eating Satisfaction
Time Frame: Measured every 4 weeks for 12 weeks
Changes in perceptions of diet / eating satisfaction assessed using using a 0 to 10 Likert scale (0 was none, 2.5 was low, 5 was moderate, and 7.5 was high, and 10 was severe) and analyzed with related satiety questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Sleep Quality Questionnaire - Sleep Duration
Time Frame: Measured every 4 weeks for 12 weeks
Changes in average reported sleep duration over the prior 48 hours analyzed with related sleep quality questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Sleep Quality Questionnaire - Sleep Quality
Time Frame: Measured every 4 weeks for 12 weeks
Changes in rating of sleep quality over the prior 48 hours analyzed with related sleep quality questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Sleep Quality Questionnaire - Enthusiasm
Time Frame: Measured every 4 weeks for 12 weeks
Changes in rating of enthusiasm over the prior 48 hours analyzed with related sleep quality questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Sleep Quality Questionnaire - Sleep Disturbances
Time Frame: Measured every 4 weeks for 12 weeks
Changes in rating of sleep disturbances over the prior 48 hours analyzed with related sleep quality questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Perceptions of Side Effects - Dizziness
Time Frame: Measured every 4 weeks for 12 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 and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Perceptions of Side Effects - Headache
Time Frame: Measured every 4 weeks for 12 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 and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Perceptions of Side Effects - Tachycardia
Time Frame: Measured every 4 weeks for 12 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 and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Perceptions of Side Effects - Palpitations
Time Frame: Measured every 4 weeks for 12 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 and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Perceptions of Side Effects - Dyspnea
Time Frame: Measured every 4 weeks for 12 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 and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Perceptions of Side Effects - Nervousness
Time Frame: Measured every 4 weeks for 12 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 and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Perceptions of Side Effects - Blurred Vision
Time Frame: Measured every 4 weeks for 12 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 and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 weeks
Perceptions of Side Effects - Other Side Effects
Time Frame: Measured every 4 weeks for 12 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 and mean changes from baseline with 95% confidence intervals (CI's).
Measured every 4 weeks for 12 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.
June 1, 2017

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.
March 31, 2018

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, 2018

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).
December 18, 2017

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.
January 3, 2018

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.
January 10, 2018

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.
September 10, 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.
September 9, 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.
December 1, 2017

More Information

Terms related to this study

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.
  • IRB2016-0829FX

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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