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

NCT03116711 | Completed DMC

• 1 other identifier: IRB2013-0737F
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diet Modification

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (5)

• 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

Study Arms (4)

Positive CIQ plus High Carbohydrate Diet

ACTIVE COMPARATOR

Positive Carbohydrate Intolerance Questionnaire (CIQ) plus 30% carbohydrate, 45% protein, 25% fat diet

Other: Positive CIQ plus High Carbohydrate Diet

Positive CIQ plus High Protein Diet

ACTIVE COMPARATOR

Positive Carbohydrate Intolerance Questionnaire (CIQ) plus 20% carbohydrate, 45% protein, 35% fat diet

Other: Positive CIQ plus High Protein Diet

Negative CIQ plus High Carbohydrate Diet

ACTIVE COMPARATOR

Negative Carbohydrate Intolerance Questionnaire (CIQ) plus 30% carbohydrate, 45% protein, 25% fat diet

Other: Negative CIQ plus High Carbohydrate Diet

Negative CIQ plus High Protein Diet

ACTIVE COMPARATOR

Negative Carbohydrate Intolerance Questionnaire (CIQ) plus 20% carbohydrate, 45% protein, 35% fat diet

Other: Negative CIQ plus High Protein Diet

Interventions

Positive CIQ plus High Carbohydrate Diet OTHER

Positive Carbohydrate Intolerance Questionnaire plus High Carbohydrate Diet

Positive CIQ plus High Carbohydrate Diet

Positive CIQ plus High Protein Diet OTHER

Positive Carbohydrate Intolerance Questionnaire plus High Protein Diet

Positive CIQ plus High Protein Diet

Negative CIQ plus High Carbohydrate Diet OTHER

Negative Carbohydrate Intolerance Questionnaire plus High Carbohydrate Diet

Negative CIQ plus High Carbohydrate Diet

Negative CIQ plus High Protein Diet OTHER

Negative Carbohydrate Intolerance Questionnaire plus High Protein Diet

Negative CIQ plus High Protein Diet

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: The eligibility criteria were at the request of the study sponsor.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The participant is an apparently healthy female
• The participant is between the ages of 18 and 60

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas A&M University: lead
• Curves International: collaborator

MeSH Terms

Interventions

Diet, High-Protein

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Richard B Kreider, PhD

  Texas A&M University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 17, 2017
• Study Start: November 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: April 17, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share