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Effects of a Dietary Supplement Containing L-Arabinose and Trivalent Patented Food-source of Chromium on Blood Glucose and Insulin

This study has been completed.
Sponsor:
Information provided by:
Integrative Health Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01107431
First received: April 19, 2010
Last updated: May 11, 2011
Last verified: May 2011
History of Changes
  Purpose

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).


Condition Intervention
Pre-diabetes
 Dietary Supplement: L-Arabinose and Chromium
Dietary Supplement: Sucrose without dietary Supplement

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Combination of L-Arabinose and Chromium Lowers Circulating Glucose and Insulin Levels After Acute Oral Sucrose Challenge

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Integrative Health Technologies, Inc.:

Primary Outcome Measures:
  • Fasting Blood Glucose [ Time Frame: Every 15 to 30 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: Every 30 minutes ] [ Designated as safety issue: No ]
    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


Enrollment: 70
Study Start Date: December 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Dietary Supplement: L-Arabinose and Chromium
Consumed 70 grams of sucrose simultaneously taking a dietary supplement
Other Name: 70 grams of cane sugar along with supplement
Active Comparator: Sucrose without Dietary Supplement
Consumed 70 grams of sucrose without simultaneously taking the dietary supplement
 Dietary Supplement: Sucrose without dietary Supplement
Repeated measures on subjects taking 70 grams of sucrose along with taking a dietary supplement containing L-Arabinose and Chromium
Other Name: 70 grams of cane sugar with supplement

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01107431

Locations
United States, Texas
Integrative Health Technologies
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Integrative Health Technologies, Inc.
Investigators
Principal Investigator: Gilbert R Kaats, PhD Integrative Health Technologies
Principal Investigator: Harry G Preuss, MD Georgetown University
  More Information

No publications provided

Responsible Party: Gilbert R. Kaats, PhD, Integrative Health Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01107431     History of Changes
Other Study ID Numbers: Pharmachem 40-47
Study First Received: April 19, 2010
Last Updated: May 11, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Integrative Health Technologies, Inc.:
glucose
insulin
L-arabinose
Chromium

Additional relevant MeSH terms:
Glucose Intolerance
Prediabetic State
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Chromium
 Insulin
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hypoglycemic Agents

ClinicalTrials.gov processed this record on May 22, 2013