Effects of Diet Selection Based on Genetic Screening on Success to a Weight Loss Program (Curves3)

Effects of Diet Type Selection Based on Response to a Carbohydrate Intolerance Questionnaire and Genetic Screening on Success to a Weight Loss and Exercise Program

The purpose of this study is to determine the effects of diet type selection based on response to a Carbohydrate Intolerance Questionnaire (CIQ) and genetic screening on success to a weight loss and exercise program.

Study Overview

• Status: Completed
• Conditions: Diet Modification
• Intervention / Treatment: Other: Positive CIQ plus High Carbohydrate Diet; Other: Positive CIQ plus High Protein Diet; Other: Negative CIQ plus High Carbohydrate Diet; Other: Negative CIQ plus High Protein Diet

Detailed Description

The purpose of this study is to determine if stratification of individuals based on responses to a Carbohydrate Intolerance Questionnaire (CIQ), genetic screening, and/or DNA methylation affects weight loss success and/or health outcomes of women following the Curves moderate carbohydrate, high protein, low fat diet (30% carbohydrate, 45% protein, 25% fat) or the Curves carbohydrate restricted, high protein, moderate fat diet (20% carbohydrate, 45% protein, 35% fat).

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• The participant is an apparently healthy female
• The participant is between the ages of 18 and 60

Exclusion Criteria:

• The participant is pregnant or nursing, or plans to become pregnant during the next 12 months or has been pregnant in the past 12 months
• The participant has uncontrolled metabolic disorder including known electrolyte abnormalities; heart disease, arrhythmias, diabetes, thyroid disease, or hypogonadism; a history of hypertension, hepatorenal, musculoskeletal, autoimmune, or neurological disease
• The participant is currently taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive, or androgenic medications
• The participant has taken ergogenic levels of nutritional supplements that may affect muscle mass (e.g., creatine, HMB), anabolic/catabolic hormone levels (androstenedione, DHEA, etc.) or weight loss (e.g., ephedra, thermogenics, etc.) within the past three months
• The participant is willing to take participate in a regular moderate exercise program

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Positive CIQ plus High Carbohydrate Diet; Positive Carbohydrate Intolerance Questionnaire (CIQ) plus 30% carbohydrate, 45% protein, 25% fat diet	Other: Positive CIQ plus High Carbohydrate Diet; Positive Carbohydrate Intolerance Questionnaire plus High Carbohydrate Diet
Active Comparator: Positive CIQ plus High Protein Diet; Positive Carbohydrate Intolerance Questionnaire (CIQ) plus 20% carbohydrate, 45% protein, 35% fat diet	Other: Positive CIQ plus High Protein Diet; Positive Carbohydrate Intolerance Questionnaire plus High Protein Diet
Active Comparator: Negative CIQ plus High Carbohydrate Diet; Negative Carbohydrate Intolerance Questionnaire (CIQ) plus 30% carbohydrate, 45% protein, 25% fat diet	Other: Negative CIQ plus High Carbohydrate Diet; Negative Carbohydrate Intolerance Questionnaire plus High Carbohydrate Diet
Active Comparator: Negative CIQ plus High Protein Diet; Negative Carbohydrate Intolerance Questionnaire (CIQ) plus 20% carbohydrate, 45% protein, 35% fat diet	Other: Negative CIQ plus High Protein Diet; Negative Carbohydrate Intolerance Questionnaire plus High Protein Diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Effects of diet selection on physical activity patterns changes (steps per day)	24 weeks
Effects of diet selection on body weight changes (pounds)	24 weeks
Effects of diet selection on hip/waist ratio changes (inches)	24 weeks
Effects of diet selection on Resting Energy Expenditure (REE) changes (calories per day)	24 weeks
Effects of diet selection on Blood Pressure (BP) changes (mmHG)	24 weeks
Effects of diet selection on Heart Rate (HR) changes (beats per minute)	24 weeks
Effects of diet selection on body composition (DXA) changes (percent fat mass)	24 weeks
Effects of diet selection on Bioelectrical Impedance Analysis (BIA) changes (flow impedance)	24 weeks
Effects of diet selection on a chemistry-15 blood panel changes	24 weeks
Effects of diet selection on a cell blood count (CBC) blood panel changes	24 weeks
Effects of diet selection on lipid panel changes	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Effects of diet selection on maximal cardiopulmonary capacity changes (ml/kg/min)	24 weeks
Effects of diet selection on muscular strength through a 1 repetition maximum (1 RM) test	24 weeks
Effects of diet selection on muscular endurance through a maximal repetition test	24 weeks
Effects of diet selection on gene expression changes	24 weeks
Effects of diet selection on DNA methylation changes	24 weeks

Collaborators and Investigators

• Sponsor: Texas A&M University
• Collaborators: Curves International
• Investigators: Principal Investigator: Richard B Kreider, PhD, Texas A&M University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: April 11, 2017
• First Posted (Actual): April 17, 2017

Study Record Updates

• Last Update Posted (Actual): April 17, 2017
• Last Update Submitted That Met QC Criteria: April 11, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: IRB2013-0737F

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