Diet Modification
Conditions
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).
Interventions
OTHERPositive CIQ plus High Carbohydrate Diet
Positive Carbohydrate Intolerance Questionnaire plus High Carbohydrate Diet
OTHERPositive CIQ plus High Protein Diet
Positive Carbohydrate Intolerance Questionnaire plus High Protein Diet
OTHERNegative CIQ plus High Carbohydrate Diet
Negative Carbohydrate Intolerance Questionnaire plus High Carbohydrate Diet
OTHERNegative CIQ plus High Protein Diet
Negative Carbohydrate Intolerance Questionnaire plus High Protein Diet
Sponsors
Curves International
Texas A&M University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effects of diet selection on lipid 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 body composition (DXA) changes (percent fat mass) | 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 Bioelectrical Impedance Analysis (BIA) changes (flow impedance) | 24 weeks |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Effects of diet selection on maximal cardiopulmonary capacity changes (ml/kg/min) | 24 weeks |
Outcome results
None listed