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Carbohydrate Intolerance Questionnaire Study

NCT03138902 — Not applicable, Completed, 108 participants, Texas A&M University

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Validation of Carbohydrate Intolerance Questionnaire

RegistryNCT03138902, acronym Curves1
StatusCompleted
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, treatment
Enrollment108 (Actual)
SponsorTexas A&M University (Other); collaborators: Curves International
ConditionsCarbohydrate Intolerance
InterventionsTRUTOL Glucose Tolerance Beverage (Dietary supplement)
Datesstart 2013-06-01, primary completion 2013-12-31, completion 2013-12-31, first posted 2017-05-03, last updated 2017-05-03

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-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).

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Glucose Tolerance BeverageExperimentalDietary Supplement: TRUTOL Glucose Tolerance Beverage75 g. of a fruit punch flavored oral glucose solution
  • TRUTOL Glucose Tolerance Beverage (Dietary supplement): A caffeine-free, non-carbonated, glucose tolerance beverage

+Outcome measures

Primary outcomes

  • Complete a Carbohydrate Intolerance Questionnaire (CIQ) [1 day]: Primary Outcome
  • Complete a 2 Hour Oral Glucose Tolerance Test (OGTT) to measure glucose response [2 hours]: Primary Outcome
  • Complete a 2 Hour Oral Glucose Tolerance Test (OGTT) to measure insulin response [2 hours]: Primary Outcome

+Eligibility

Sex: Female, ages: 18 Years to 60 Years, accepts 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

+Investigators

My Notes