Carbohydrate Intolerance Questionnaire Study

Carbohydrate Intolerance Clinical Trial

— Curves1  

Official title:

Validation of Carbohydrate Intolerance Questionnaire

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03138902
• Other study ID #: IRB2013-0401
• 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
• 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

Related Conditions & MeSH terms

• Carbohydrate Intolerance
• Carbohydrate Metabolism, Inborn Errors
• Malabsorption Syndromes

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