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Effects of Diet Selection Based on Genetic Screening on Success to a Weight Loss Program (Curves3)

Primary Purpose

Diet Modification

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Positive CIQ plus High Carbohydrate Diet
Positive CIQ plus High Protein Diet
Negative CIQ plus High Carbohydrate Diet
Negative CIQ plus High Protein Diet
Sponsored by
Texas A&M University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diet Modification

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Positive CIQ plus High Carbohydrate Diet

    Positive CIQ plus High Protein Diet

    Negative CIQ plus High Carbohydrate Diet

    Negative CIQ plus High Protein Diet

    Arm Description

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

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

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

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

    Outcomes

    Primary Outcome Measures

    Effects of diet selection on physical activity patterns changes (steps per day)
    Effects of diet selection on body weight changes (pounds)
    Effects of diet selection on hip/waist ratio changes (inches)
    Effects of diet selection on Resting Energy Expenditure (REE) changes (calories per day)
    Effects of diet selection on Blood Pressure (BP) changes (mmHG)
    Effects of diet selection on Heart Rate (HR) changes (beats per minute)
    Effects of diet selection on body composition (DXA) changes (percent fat mass)
    Effects of diet selection on Bioelectrical Impedance Analysis (BIA) changes (flow impedance)
    Effects of diet selection on a chemistry-15 blood panel changes
    Effects of diet selection on a cell blood count (CBC) blood panel changes
    Effects of diet selection on lipid panel changes

    Secondary Outcome Measures

    Effects of diet selection on maximal cardiopulmonary capacity changes (ml/kg/min)
    Effects of diet selection on muscular strength through a 1 repetition maximum (1 RM) test
    Effects of diet selection on muscular endurance through a maximal repetition test
    Effects of diet selection on gene expression changes
    Effects of diet selection on DNA methylation changes

    Full Information

    First Posted
    March 29, 2017
    Last Updated
    April 11, 2017
    Sponsor
    Texas A&M University
    Collaborators
    Curves International
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03116711
    Brief Title
    Effects of Diet Selection Based on Genetic Screening on Success to a Weight Loss Program
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1, 2013 (Actual)
    Primary Completion Date
    July 1, 2015 (Actual)
    Study Completion Date
    July 1, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Texas A&M University
    Collaborators
    Curves International

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diet Modification

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    51 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Positive CIQ plus High Carbohydrate Diet
    Arm Type
    Active Comparator
    Arm Description
    Positive Carbohydrate Intolerance Questionnaire (CIQ) plus 30% carbohydrate, 45% protein, 25% fat diet
    Arm Title
    Positive CIQ plus High Protein Diet
    Arm Type
    Active Comparator
    Arm Description
    Positive Carbohydrate Intolerance Questionnaire (CIQ) plus 20% carbohydrate, 45% protein, 35% fat diet
    Arm Title
    Negative CIQ plus High Carbohydrate Diet
    Arm Type
    Active Comparator
    Arm Description
    Negative Carbohydrate Intolerance Questionnaire (CIQ) plus 30% carbohydrate, 45% protein, 25% fat diet
    Arm Title
    Negative CIQ plus High Protein Diet
    Arm Type
    Active Comparator
    Arm Description
    Negative Carbohydrate Intolerance Questionnaire (CIQ) plus 20% carbohydrate, 45% protein, 35% fat diet
    Intervention Type
    Other
    Intervention Name(s)
    Positive CIQ plus High Carbohydrate Diet
    Intervention Description
    Positive Carbohydrate Intolerance Questionnaire plus High Carbohydrate Diet
    Intervention Type
    Other
    Intervention Name(s)
    Positive CIQ plus High Protein Diet
    Intervention Description
    Positive Carbohydrate Intolerance Questionnaire plus High Protein Diet
    Intervention Type
    Other
    Intervention Name(s)
    Negative CIQ plus High Carbohydrate Diet
    Intervention Description
    Negative Carbohydrate Intolerance Questionnaire plus High Carbohydrate Diet
    Intervention Type
    Other
    Intervention Name(s)
    Negative CIQ plus High Protein Diet
    Intervention Description
    Negative Carbohydrate Intolerance Questionnaire plus High Protein Diet
    Primary Outcome Measure Information:
    Title
    Effects of diet selection on physical activity patterns changes (steps per day)
    Time Frame
    24 weeks
    Title
    Effects of diet selection on body weight changes (pounds)
    Time Frame
    24 weeks
    Title
    Effects of diet selection on hip/waist ratio changes (inches)
    Time Frame
    24 weeks
    Title
    Effects of diet selection on Resting Energy Expenditure (REE) changes (calories per day)
    Time Frame
    24 weeks
    Title
    Effects of diet selection on Blood Pressure (BP) changes (mmHG)
    Time Frame
    24 weeks
    Title
    Effects of diet selection on Heart Rate (HR) changes (beats per minute)
    Time Frame
    24 weeks
    Title
    Effects of diet selection on body composition (DXA) changes (percent fat mass)
    Time Frame
    24 weeks
    Title
    Effects of diet selection on Bioelectrical Impedance Analysis (BIA) changes (flow impedance)
    Time Frame
    24 weeks
    Title
    Effects of diet selection on a chemistry-15 blood panel changes
    Time Frame
    24 weeks
    Title
    Effects of diet selection on a cell blood count (CBC) blood panel changes
    Time Frame
    24 weeks
    Title
    Effects of diet selection on lipid panel changes
    Time Frame
    24 weeks
    Secondary Outcome Measure Information:
    Title
    Effects of diet selection on maximal cardiopulmonary capacity changes (ml/kg/min)
    Time Frame
    24 weeks
    Title
    Effects of diet selection on muscular strength through a 1 repetition maximum (1 RM) test
    Time Frame
    24 weeks
    Title
    Effects of diet selection on muscular endurance through a maximal repetition test
    Time Frame
    24 weeks
    Title
    Effects of diet selection on gene expression changes
    Time Frame
    24 weeks
    Title
    Effects of diet selection on DNA methylation changes
    Time Frame
    24 weeks

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    The eligibility criteria were at the request of the study sponsor.
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Richard B Kreider, PhD
    Organizational Affiliation
    Texas A&M University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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