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

Not Applicable

Completed

• Conditions: Diet Modification
• Interventions: Other: Negative CIQ plus High Carbohydrate Diet; Other: Positive CIQ plus High Protein Diet; Other: Negative CIQ plus High Protein Diet; Other: Positive CIQ plus High Carbohydrate Diet

• Registration Number: NCT03116711
• Lead Sponsor: Texas A&M University

Brief Summary

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.

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 Timeline

• Study Start: 2013-11-01
• Primary Completion: 2015-07-01
• Study Completion: 2015-07-01
• Status Verified: 2017-03
• Study First Submitted: 2017-03-29
• Study First Submitted QC: 2017-04-11
• Last Update Submitted: 2017-04-11
• Study First Posted: 2017-04-17
• Last Update Posted: 2017-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 51

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Negative CIQ plus High Carbohydrate Diet	Negative CIQ plus High Carbohydrate Diet	Negative Carbohydrate Intolerance Questionnaire (CIQ) plus 30% carbohydrate, 45% protein, 25% fat diet
Positive CIQ plus High Protein Diet	Positive CIQ plus High Protein Diet	Positive Carbohydrate Intolerance Questionnaire (CIQ) plus 20% carbohydrate, 45% protein, 35% fat diet
Negative CIQ plus High Protein Diet	Negative CIQ plus High Protein Diet	Negative Carbohydrate Intolerance Questionnaire (CIQ) plus 20% carbohydrate, 45% protein, 35% fat diet
Positive CIQ plus High Carbohydrate Diet	Positive CIQ plus High Carbohydrate Diet	Positive Carbohydrate Intolerance Questionnaire (CIQ) plus 30% carbohydrate, 45% protein, 25% fat diet

Primary Outcome Measures

Name	Time	Method
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 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 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 a cell blood count (CBC) blood panel changes	24 weeks
Effects of diet selection on lipid panel changes	24 weeks

Secondary Outcome Measures

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