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Carbohydrate Intolerance Questionnaire Study (Curves1)

Primary Purpose

Carbohydrate Intolerance

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TRUTOL Glucose Tolerance Beverage
Sponsored by
Texas A&M University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carbohydrate Intolerance

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Participant is female
  • Participant is between the ages of 18 and 60

Exclusion Criteria:

  • Participant is pregnant or nursing
  • Participant is diabetic or pre-diabetic
  • Participant has a Body Mass Index (BMI) < 22

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Glucose Tolerance Beverage

    Arm Description

    75 g. of a fruit punch flavored oral glucose solution

    Outcomes

    Primary Outcome Measures

    Complete a Carbohydrate Intolerance Questionnaire (CIQ)
    Primary Outcome
    Complete a 2 Hour Oral Glucose Tolerance Test (OGTT) to measure glucose response
    Primary Outcome
    Complete a 2 Hour Oral Glucose Tolerance Test (OGTT) to measure insulin response
    Primary Outcome

    Secondary Outcome Measures

    Full Information

    First Posted
    April 25, 2017
    Last Updated
    May 2, 2017
    Sponsor
    Texas A&M University
    Collaborators
    Curves International
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03138902
    Brief Title
    Carbohydrate Intolerance Questionnaire Study
    Acronym
    Curves1
    Official Title
    Validation of Carbohydrate Intolerance Questionnaire
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2013 (Actual)
    Primary Completion Date
    December 31, 2013 (Actual)
    Study Completion Date
    December 31, 2013 (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 evaluate the validity of using a carbohydrate intolerance questionnaire (CIQ) and/or other health markers as a means of predicting response to insulin sensitivity as determined by an oral glucose tolerance test (OGTT).
    Detailed Description
    This study will utilize a carbohydrate intolerance questionnaire (CIQ). Responses to a CIQ will be correlated with diet inventories, baseline body composition and health assessments, a standard metabolic panel, fasting glucose and insulin levels, a homeostatic insulin resistance model (HOMA), a two hour oral glucose tolerance test (OGTT), and a carbohydrate sensitivity symptom questionnaire administered during the OGTT.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carbohydrate Intolerance

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    108 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Glucose Tolerance Beverage
    Arm Type
    Experimental
    Arm Description
    75 g. of a fruit punch flavored oral glucose solution
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    TRUTOL Glucose Tolerance Beverage
    Intervention Description
    A caffeine-free, non-carbonated, glucose tolerance beverage
    Primary Outcome Measure Information:
    Title
    Complete a Carbohydrate Intolerance Questionnaire (CIQ)
    Description
    Primary Outcome
    Time Frame
    1 day
    Title
    Complete a 2 Hour Oral Glucose Tolerance Test (OGTT) to measure glucose response
    Description
    Primary Outcome
    Time Frame
    2 hours
    Title
    Complete a 2 Hour Oral Glucose Tolerance Test (OGTT) to measure insulin response
    Description
    Primary Outcome
    Time Frame
    2 hours

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Females were requested by the 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: Participant is female Participant is between the ages of 18 and 60 Exclusion Criteria: Participant is pregnant or nursing Participant is diabetic or pre-diabetic Participant has a Body Mass Index (BMI) < 22
    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

    Learn more about this trial

    Carbohydrate Intolerance Questionnaire Study

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