- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01107431
Effects of a Dietary Supplement Containing L-Arabinose and Trivalent Patented Food-source of Chromium on Blood Glucose and Insulin (L-Arabinose)
May 11, 2011 updated by: Integrative Health Technologies, Inc.
A Combination of L-Arabinose and Chromium Lowers Circulating Glucose and Insulin Levels After Acute Oral Sucrose Challenge
This study was designed to examine changes in capillary blood glucose and venous insulin levels after a 70 gram oral sucrose challenge with and without simultaneous consumption of a dietary supplement containing L-Arabinose and a patented version of chromium (LA-Cr).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study concluded that consumption of the LA-Cr supplement in conjunction with a 70-gram sucrose challenge led to a significant reduction of capillary blood glucose and venous insulin as compared to the sucrose challenge without the LA-Cr supplement.
This finding may provide an important tool to reduce the adverse effects associated with elevated glucose and insulin levels.
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78209
- Integrative Health Technologies
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All study subjects were required to contact their family physician to ensure they had no medical conditions that would preclude their participation.
Exclusion Criteria:
- Diabetics, and
- Those not approved by their physicians.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Sucrose with Dietary Supplement
Repeated measures on subjects taking 70 grams of sucrose along with taking a dietary supplement containing L-Arabinose and Chromium
|
Consumed 70 grams of sucrose simultaneously taking a dietary supplement
Other Names:
|
|
Active Comparator: Sucrose without Dietary Supplement
Consumed 70 grams of sucrose without simultaneously taking the dietary supplement
|
Repeated measures on subjects taking 70 grams of sucrose along with taking a dietary supplement containing L-Arabinose and Chromium
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fasting Blood Glucose
Time Frame: Every 15 to 30 minutes
|
Finger-stick glucose measurements taken every 15 or 30 minutes after taking a 70 gram sucrose challenge with and without the dietary supplement
|
Every 15 to 30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fasting Blood Insulin Levels
Time Frame: Every 30 minutes
|
A venipuncture blood test taken 30, 60, 90 and 120 minutes after taking a 70 gram sucrose challenge with and without taking the dietary supplement
|
Every 30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gilbert R Kaats, PhD, Integrative Health Technologies
- Principal Investigator: Harry G Preuss, MD, Georgetown University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
April 19, 2010
First Submitted That Met QC Criteria
April 20, 2010
First Posted (Estimate)
April 21, 2010
Study Record Updates
Last Update Posted (Estimate)
May 13, 2011
Last Update Submitted That Met QC Criteria
May 11, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pharmachem 40-47
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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