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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Texas A&M University
- Enrollment
- 51
- Primary Endpoint
- Effects of diet selection on physical activity patterns changes (steps per day)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Positive CIQ plus High Carbohydrate Diet
Positive Carbohydrate Intolerance Questionnaire (CIQ) plus 30% carbohydrate, 45% protein, 25% fat diet
Intervention: Positive CIQ plus High Carbohydrate Diet (Other)
Positive CIQ plus High Protein Diet
Positive Carbohydrate Intolerance Questionnaire (CIQ) plus 20% carbohydrate, 45% protein, 35% fat diet
Intervention: Positive CIQ plus High Protein Diet (Other)
Negative CIQ plus High Carbohydrate Diet
Negative Carbohydrate Intolerance Questionnaire (CIQ) plus 30% carbohydrate, 45% protein, 25% fat diet
Intervention: Negative CIQ plus High Carbohydrate Diet (Other)
Negative CIQ plus High Protein Diet
Negative Carbohydrate Intolerance Questionnaire (CIQ) plus 20% carbohydrate, 45% protein, 35% fat diet
Intervention: Negative CIQ plus High Protein Diet (Other)
Outcomes
Primary Outcomes
Effects of diet selection on physical activity patterns changes (steps per day)
Time Frame: 24 weeks
Effects of diet selection on body weight changes (pounds)
Time Frame: 24 weeks
Effects of diet selection on hip/waist ratio changes (inches)
Time Frame: 24 weeks
Effects of diet selection on Resting Energy Expenditure (REE) changes (calories per day)
Time Frame: 24 weeks
Effects of diet selection on body composition (DXA) changes (percent fat mass)
Time Frame: 24 weeks
Effects of diet selection on Bioelectrical Impedance Analysis (BIA) changes (flow impedance)
Time Frame: 24 weeks
Effects of diet selection on a chemistry-15 blood panel changes
Time Frame: 24 weeks
Effects of diet selection on Blood Pressure (BP) changes (mmHG)
Time Frame: 24 weeks
Effects of diet selection on Heart Rate (HR) changes (beats per minute)
Time Frame: 24 weeks
Effects of diet selection on a cell blood count (CBC) blood panel changes
Time Frame: 24 weeks
Effects of diet selection on lipid panel changes
Time Frame: 24 weeks
Secondary Outcomes
- 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)