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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03138902
Other study ID # IRB2013-0401
Secondary ID
Status Completed
Phase N/A
First received April 25, 2017
Last updated May 2, 2017
Start date June 1, 2013
Est. completion date December 31, 2013

Study information

Verified date April 2017
Source Texas A&M University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date December 31, 2013
Est. primary completion date December 31, 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
TRUTOL Glucose Tolerance Beverage
A caffeine-free, non-carbonated, glucose tolerance beverage

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Texas A&M University Curves International

Outcome

Type Measure Description Time frame Safety issue
Primary Complete a Carbohydrate Intolerance Questionnaire (CIQ) Primary Outcome 1 day
Primary Complete a 2 Hour Oral Glucose Tolerance Test (OGTT) to measure glucose response Primary Outcome 2 hours
Primary Complete a 2 Hour Oral Glucose Tolerance Test (OGTT) to measure insulin response Primary Outcome 2 hours
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