Clinical trial NCT03116711: Effects of Diet Selection Based on Genetic Screening on Success to a Weight Loss Program
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Modification
Lead sponsor: Texas A&M University
Sponsor class: OTHER
Collaborators: name: Curves International
First posted: 2017-04-17
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Eligibility criteria: 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

Primary outcomes:
measure: Effects of diet selection on physical activity patterns changes (steps per day)
timeFrame: 24 weeks
measure: Effects of diet selection on body weight changes (pounds)
timeFrame: 24 weeks
measure: Effects of diet selection on hip/waist ratio changes (inches)
timeFrame: 24 weeks
measure: Effects of diet selection on Resting Energy Expenditure (REE) changes (calories per day)
timeFrame: 24 weeks
measure: Effects of diet selection on Blood Pressure (BP) changes (mmHG)
timeFrame: 24 weeks
measure: Effects of diet selection on Heart Rate (HR) changes (beats per minute)
timeFrame: 24 weeks
measure: Effects of diet selection on body composition (DXA) changes (percent fat mass)
timeFrame: 24 weeks
measure: Effects of diet selection on Bioelectrical Impedance Analysis (BIA) changes (flow impedance)
timeFrame: 24 weeks
measure: Effects of diet selection on a chemistry-15 blood panel changes
timeFrame: 24 weeks
measure: Effects of diet selection on a cell blood count (CBC) blood panel changes
timeFrame: 24 weeks
measure: Effects of diet selection on lipid panel changes
timeFrame: 24 weeks
Secondary outcomes:
measure: Effects of diet selection on maximal cardiopulmonary capacity changes (ml/kg/min)
timeFrame: 24 weeks
measure: Effects of diet selection on muscular strength through a 1 repetition maximum (1 RM) test
timeFrame: 24 weeks
measure: Effects of diet selection on muscular endurance through a maximal repetition test
timeFrame: 24 weeks
measure: Effects of diet selection on gene expression changes
timeFrame: 24 weeks
measure: Effects of diet selection on DNA methylation changes
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Texas A&M University
name: Richard B Kreider, PhD
role: PRINCIPAL_INVESTIGATOR
References: