Carbohydrate Intolerance Questionnaire Study | NCT03138902

Studies
Carbohydrate Intolerance Questionnaire Study

NCT03138902

Sponsor

Texas A&M University

Status

Completed

Last Update Posted

May 3, 2017Actual

Enrollment

108Actual

Phase

Not Applicable

Conditions

Carbohydrate Intolerance

Interventions

TRUTOL Glucose Tolerance Beverage

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2013Actual

Primary Completion Date

Dec 31, 2013Actual

Completion Date

Dec 31, 2013Actual

First Submitted Date

Apr 25, 2017

First Submission Date that Met QC Criteria

May 2, 2017

First Posted Date

May 3, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 2, 2017

Last Update Posted Date

May 3, 2017Actual

Name	Class
Curves International	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

108Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Glucose Tolerance Beverage	Experimental	75 g. of a fruit punch flavored oral glucose solution	Dietary Supplement: TRUTOL Glucose Tolerance Beverage

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TRUTOL Glucose Tolerance Beverage	Dietary Supplement	A caffeine-free, non-carbonated, glucose tolerance beverage	Glucose Tolerance Beverage

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Females were requested by the Sponsor

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard B Kreider, PhD	Texas A&M University	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
C562602	Glucose-Galactose Malabsorption

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided