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
About this trial
This is an interventional treatment trial for Carbohydrate Intolerance
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
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
NCT ID
NCT03138902
First Posted
April 25, 2017
Last Updated
May 2, 2017
Sponsor
Texas A&M University
Collaborators
Curves International
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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