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

Diet Modification Clinical Trial

— Curves3  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03116711
• Other study ID #: IRB2013-0737F
• Status: Completed
• Phase: N/A
• First received: March 29, 2017
• Last updated: April 11, 2017
• Start date: November 1, 2013
• Est. completion date: July 1, 2015

Study information

• Verified date: March 2017
• Source: Texas A&M University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: July 1, 2015
• Est. primary completion date: July 1, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet Modification
• Weight Loss

Intervention

Other:
• Positive CIQ plus High Carbohydrate Diet
Positive Carbohydrate Intolerance Questionnaire plus High Carbohydrate Diet
• Positive CIQ plus High Protein Diet
Positive Carbohydrate Intolerance Questionnaire plus High Protein Diet
• Negative CIQ plus High Carbohydrate Diet
Negative Carbohydrate Intolerance Questionnaire plus High Carbohydrate Diet
• Negative CIQ plus High Protein Diet
Negative Carbohydrate Intolerance Questionnaire plus High Protein Diet

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Texas A&M University	Curves International

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of diet selection on physical activity patterns changes (steps per day)		24 weeks
Primary	Effects of diet selection on body weight changes (pounds)		24 weeks
Primary	Effects of diet selection on hip/waist ratio changes (inches)		24 weeks
Primary	Effects of diet selection on Resting Energy Expenditure (REE) changes (calories per day)		24 weeks
Primary	Effects of diet selection on Blood Pressure (BP) changes (mmHG)		24 weeks
Primary	Effects of diet selection on Heart Rate (HR) changes (beats per minute)		24 weeks
Primary	Effects of diet selection on body composition (DXA) changes (percent fat mass)		24 weeks
Primary	Effects of diet selection on Bioelectrical Impedance Analysis (BIA) changes (flow impedance)		24 weeks
Primary	Effects of diet selection on a chemistry-15 blood panel changes		24 weeks
Primary	Effects of diet selection on a cell blood count (CBC) blood panel changes		24 weeks
Primary	Effects of diet selection on lipid panel changes		24 weeks
Secondary	Effects of diet selection on maximal cardiopulmonary capacity changes (ml/kg/min)		24 weeks
Secondary	Effects of diet selection on muscular strength through a 1 repetition maximum (1 RM) test		24 weeks
Secondary	Effects of diet selection on muscular endurance through a maximal repetition test		24 weeks
Secondary	Effects of diet selection on gene expression changes		24 weeks
Secondary	Effects of diet selection on DNA methylation changes		24 weeks