Carbohydrate IntoleranceCurves1NCT03138902
Carbohydrate Intolerance Questionnaire Study
A study testing TRUTOL Glucose Tolerance Beverage in people with Carbohydrate Intolerance, run by Texas A&M University.
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). Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Carbohydrate Intolerance
- What is being tested?
- TRUTOL Glucose Tolerance Beverage
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2013to 31 Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant is female
- Participant is between the ages of 18 and 60
Who cannot join
- Participant is pregnant or nursing
- Participant is diabetic or pre-diabetic
- Participant has a Body Mass Index (BMI) < 22
About this study
Official title: 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).
Read the 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.
- Conditions
- Carbohydrate Intolerance
- Being tested
- TRUTOL Glucose Tolerance Beverage
- Medical subject headings
- Glucose-Galactose Malabsorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRUTOL Glucose Tolerance BeverageDietary supplement
A caffeine-free, non-carbonated, glucose tolerance beverage
| Study group | Role | What they receive |
|---|---|---|
| Glucose Tolerance Beverage | Experimental | 75 g. of a fruit punch flavored oral glucose solution Receives: Dietary Supplement: TRUTOL Glucose Tolerance Beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete a Carbohydrate Intolerance Questionnaire (CIQ)
Primary Outcome
Measured: 1 day
Complete a 2 Hour Oral Glucose Tolerance Test (OGTT) to measure glucose response
Primary Outcome
Measured: 2 hours
Complete a 2 Hour Oral Glucose Tolerance Test (OGTT) to measure insulin response
Primary Outcome
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start1 Jun 2013
- Primary completion31 Dec 2013
- Study completion31 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbohydrate IntoleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Collaborators
- Curves International
- Responsible party
- Sponsor
- Investigators
- Richard B Kreider, PhD, Principal investigator, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138902
- Sponsor's protocol ID
- IRB2013-0401
- Acronym
- Curves1
- Status last verified
- Apr 2017
- First submitted
- 25 Apr 2017
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Carbohydrate Intolerance Questionnaire
- ClinicalTrials.gov ID
- NCT03138902
- Acronym / sponsor ID
- Curves1 / IRB2013-0401
- Conditions
- Carbohydrate Intolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Collaborators
- Curves International
- Study start
- 1 Jun 2013 (actual)
- Primary completion
- 31 Dec 2013 (actual)
- Study completion
- 31 Dec 2013 (actual)
- First posted
- 3 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glucose Tolerance Beverage | Experimental | Dietary Supplement: TRUTOL Glucose Tolerance Beverage75 g. of a fruit punch flavored oral glucose solution |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participant is female
- Participant is between the ages of 18 and 60
Key exclusion criteria (3 listed)
- Participant is pregnant or nursing
- Participant is diabetic or pre-diabetic
- Participant has a Body Mass Index (BMI) < 22
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRUTOL Glucose Tolerance BeverageA caffeine-free, non-carbonated, glucose tolerance beverage | Dietary supplement | Glucose Tolerance Beverage |
Primary outcome
Complete a Carbohydrate Intolerance Questionnaire (CIQ)
Time frame: 1 day
Primary Outcome
Complete a 2 Hour Oral Glucose Tolerance Test (OGTT) to measure glucose response
Time frame: 2 hours
Primary Outcome
Complete a 2 Hour Oral Glucose Tolerance Test (OGTT) to measure insulin response
Time frame: 2 hours
Primary Outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard B Kreider, PhD principal investigator
Texas A&M University
Questions about this trial
What is this clinical trial studying?
A study testing TRUTOL Glucose Tolerance Beverage in people with Carbohydrate Intolerance, run by Texas A&M University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete a Carbohydrate Intolerance Questionnaire (CIQ) (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2017.