NCT03138902

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2013

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2013

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 3, 2017

Completed
Last Updated

May 3, 2017

Status Verified

April 1, 2017

Enrollment Period

7 months

First QC Date

April 25, 2017

Last Update Submit

May 2, 2017

Conditions

Carbohydrate Intolerance

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

Glucose Tolerance Beverage

EXPERIMENTAL

75 g. of a fruit punch flavored oral glucose solution

Dietary Supplement: TRUTOL Glucose Tolerance Beverage

Interventions

TRUTOL Glucose Tolerance BeverageDIETARY_SUPPLEMENT

A caffeine-free, non-carbonated, glucose tolerance beverage

Glucose Tolerance Beverage

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales were requested by the Sponsor
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participant is female
  • Participant is between the ages of 18 and 60

You may not qualify if:

  • Participant is pregnant or nursing
  • Participant is diabetic or pre-diabetic
  • Participant has a Body Mass Index (BMI) \< 22

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glucose-Galactose Malabsorption

Study Officials

  • Richard B Kreider, PhD

    Texas A&M University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2017

First Posted

May 3, 2017

Study Start

June 1, 2013

Primary Completion

December 31, 2013

Study Completion

December 31, 2013

Last Updated

May 3, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share