Carbohydrate Intolerance Questionnaire Study (Curves1)

Validation of Carbohydrate Intolerance Questionnaire

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).

Study Overview

• Status: Completed
• Conditions: Carbohydrate Intolerance
• Intervention / Treatment: Dietary supplement: TRUTOL Glucose Tolerance Beverage

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.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glucose Tolerance Beverage; 75 g. of a fruit punch flavored oral glucose solution	Dietary supplement: TRUTOL Glucose Tolerance Beverage; A caffeine-free, non-carbonated, glucose tolerance beverage

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Texas A&M University
• Collaborators: Curves International
• Investigators: Principal Investigator: Richard B Kreider, PhD, Texas A&M University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2013
• Primary Completion (Actual): December 31, 2013
• Study Completion (Actual): December 31, 2013

Study Registration Dates

• First Submitted: April 25, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (Actual): May 3, 2017

Study Record Updates

• Last Update Posted (Actual): May 3, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Genetic Diseases, Inborn; Intestinal Diseases; Metabolism, Inborn Errors; Malabsorption Syndromes; Carbohydrate Metabolism, Inborn Errors
• Other Study ID Numbers: IRB2013-0401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No