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Completed

NCT Number: NCT03116711

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

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.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Positive CIQ plus High Carbohydrate Diet

Other

Positive Carbohydrate Intolerance Questionnaire plus High Carbohydrate Diet

Positive CIQ plus High Protein Diet

Other

Positive Carbohydrate Intolerance Questionnaire plus High Protein Diet

Negative CIQ plus High Carbohydrate Diet

Other

Negative Carbohydrate Intolerance Questionnaire plus High Carbohydrate Diet

Negative CIQ plus High Protein Diet

Other

Negative Carbohydrate Intolerance Questionnaire plus High Protein Diet

Primary outcomes

  1. Effects of diet selection on physical activity patterns changes (steps per day)

    Time frame: 24 weeks

  2. Effects of diet selection on body weight changes (pounds)

    Time frame: 24 weeks

  3. Effects of diet selection on hip/waist ratio changes (inches)

    Time frame: 24 weeks

  4. Effects of diet selection on Resting Energy Expenditure (REE) changes (calories per day)

    Time frame: 24 weeks

  5. Effects of diet selection on Blood Pressure (BP) changes (mmHG)

    Time frame: 24 weeks

  6. Effects of diet selection on Heart Rate (HR) changes (beats per minute)

    Time frame: 24 weeks

  7. Effects of diet selection on body composition (DXA) changes (percent fat mass)

    Time frame: 24 weeks

  8. Effects of diet selection on Bioelectrical Impedance Analysis (BIA) changes (flow impedance)

    Time frame: 24 weeks

  9. Effects of diet selection on a chemistry-15 blood panel changes

    Time frame: 24 weeks

  10. Effects of diet selection on a cell blood count (CBC) blood panel changes

    Time frame: 24 weeks

  11. Effects of diet selection on lipid panel changes

    Time frame: 24 weeks

Secondary outcomes

  1. Effects of diet selection on maximal cardiopulmonary capacity changes (ml/kg/min)

    Time frame: 24 weeks

  2. Effects of diet selection on muscular strength through a 1 repetition maximum (1 RM) test

    Time frame: 24 weeks

  3. Effects of diet selection on muscular endurance through a maximal repetition test

    Time frame: 24 weeks

  4. Effects of diet selection on gene expression changes

    Time frame: 24 weeks

  5. Effects of diet selection on DNA methylation changes

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Collaborators

  • Curves International

Registry information

Official study 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

Acronym: Curves3

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 17, 2017
Registry last updated
Apr 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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