Back to resultsEffects of a Dietary Supplement Containing L-Arabinose and Trivalent Patented Food-source of Chromium on Blood Glucose and Insulin (L-Arabinose)
Primary Purpose
Pre-diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
L-Arabinose and Chromium
Sucrose without dietary Supplement
Sponsored by
About this trial
This is an interventional prevention trial for Pre-diabetes focused on measuring glucose, insulin, L-arabinose, Chromium
Eligibility Criteria
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.
Sites / Locations
- Integrative Health Technologies
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Sucrose with Dietary Supplement
Sucrose without Dietary Supplement
Arm Description
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 without simultaneously taking the dietary supplement
Outcomes
Primary Outcome Measures
Fasting Blood Glucose
Finger-stick glucose measurements taken every 15 or 30 minutes after taking a 70 gram sucrose challenge with and without the dietary supplement
Secondary Outcome Measures
Fasting Blood Insulin Levels
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
Full Information
NCT ID
NCT01107431
First Posted
April 19, 2010
Last Updated
May 11, 2011
Sponsor
Integrative Health Technologies, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01107431
Brief Title
Effects of a Dietary Supplement Containing L-Arabinose and Trivalent Patented Food-source of Chromium on Blood Glucose and Insulin
Acronym
L-Arabinose
Official Title
A Combination of L-Arabinose and Chromium Lowers Circulating Glucose and Insulin Levels After Acute Oral Sucrose Challenge
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Integrative Health Technologies, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-diabetes
Keywords
glucose, insulin, L-arabinose, Chromium
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sucrose with Dietary Supplement
Arm Type
Active Comparator
Arm Description
Repeated measures on subjects taking 70 grams of sucrose along with taking a dietary supplement containing L-Arabinose and Chromium
Arm Title
Sucrose without Dietary Supplement
Arm Type
Active Comparator
Arm Description
Consumed 70 grams of sucrose without simultaneously taking the dietary supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
L-Arabinose and Chromium
Other Intervention Name(s)
70 grams of cane sugar along with supplement
Intervention Description
Consumed 70 grams of sucrose simultaneously taking a dietary supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Sucrose without dietary Supplement
Other Intervention Name(s)
70 grams of cane sugar with supplement
Intervention Description
Repeated measures on subjects taking 70 grams of sucrose along with taking a dietary supplement containing L-Arabinose and Chromium
Primary Outcome Measure Information:
Title
Fasting Blood Glucose
Description
Finger-stick glucose measurements taken every 15 or 30 minutes after taking a 70 gram sucrose challenge with and without the dietary supplement
Time Frame
Every 15 to 30 minutes
Secondary Outcome Measure Information:
Title
Fasting Blood Insulin Levels
Description
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
Time Frame
Every 30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilbert R Kaats, PhD
Organizational Affiliation
Integrative Health Technologies
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Harry G Preuss, MD
Organizational Affiliation
Georgetown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Integrative Health Technologies
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21548959
Citation
Kaats GR, Keith SC, Keith PL, Leckie RB, Perricone NV, Preuss HG. A combination of l-arabinose and chromium lowers circulating glucose and insulin levels after an acute oral sucrose challenge. Nutr J. 2011 May 6;10:42. doi: 10.1186/1475-2891-10-42.
Results Reference
derived
Learn more about this trial
Effects of a Dietary Supplement Containing L-Arabinose and Trivalent Patented Food-source of Chromium on Blood Glucose and Insulin
We'll reach out to this number within 24 hrs