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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Diet Modification

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |