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Effect of Different Doses of Salacinol Extract on Glycemic and Insulinemic Response in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Ross Products
ClinicalTrials.gov Identifier:
NCT00306072
First received: March 20, 2006
Last updated: January 26, 2010
Last verified: March 2006
History of Changes
  Purpose

The purpose of this study is to evaluate two levels of the herbal extract Salacia oblonga (salacinol) on postprandial glycemia and insulinemia in patients with Type 2 diabetes after ingestion of a high-carbohydrate control meal.


Condition Intervention Phase
Diabetes Mellitus
 Drug: nutritional herbal extract from Salacia oblonga
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effect of Different Doses of Salacinol Extract on Glycemic and Insulinemic Response in Patients With Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ross Products:

Primary Outcome Measures:
  • The primary variable to be measured was positive AUC (0-180 minutes) for plasma glucose.

Secondary Outcome Measures:
  • The secondary variables to be measured were:
  • · Positive AUC (0 to 120 minutes) for plasma and serum glucose and positive AUC (0 to 180 minutes) for serum glucose
  • · Adjusted peak value for plasma and serum glucose
  • · Adjusted peak value for serum insulin
  • · Positive AUC 0-180 (0 to 120) minutes for serum insulin

Estimated Enrollment: 82
Study Start Date: June 2005
Estimated Study Completion Date: September 2005
Detailed Description:

Although we have generated a good quantity of animal and human data on the salacinol extract, we have not explored the effect of the salacinol extract on postprandial glycemia or insulinemia in patients with type 2 diabetes.

We planned to study 66 patients with diabetes in this multicenter, randomized, double-blind, three-treatment, crossover study. While in a fasted state, subjects were to consume one of the following three meals: a standard liquid meal containing 110 g carbohydrate, 18 g protein, 12 g fat, and 620 kilocalories (Control); Control plus 240 mg Salacia oblonga extract; and Control plus 480 mg Salacia oblonga extract. Postprandial serum glucose and serum insulin samples were to be analyzed for 180 min.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject has type 2 diabetes mellitus verified by prescription of oral antihyperglycemic medications.
  2. Subject is 18 to 75 years of age, inclusively.
  3. Subject is male or a nonpregnant, nonlactating female, at least six weeks postpartum. A urine pregnancy test is required for all female subjects unless subject has had a hysterectomy, tubal ligation, or is > 2 years postmenopausal.
  4. Subject has a body mass index (BMI) of 18 - 35 kg/m2.
  5. Subject has voluntarily signed and dated an informed consent form, approved by an Independent Ethics Committee/Institutional Review Board and provided HIPAA (or other applicable privacy regulation) authorization prior to any participation in the study.

Exclusion Criteria:

  1. Subject uses exogenous insulin for glucose control.
  2. Subject states that he/she has an infection (requiring medication or hospitalization).
  3. Subject states that he/she has current hepatic disease.
  4. Subject states that he/she has had surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks.
  5. Subject has a first-degree relative enrolled in the current study.
  6. Subject states that he/she has an active malignancy (subjects with cutaneous malignancies, other than melanoma, may be included in the study).
  7. Subject states that he/she has had a significant cardiovascular event < 12 weeks prior to study entry.
  8. Subject states that he/she has end stage organ failure, including clinically advanced renal disease as assessed by the study physician.
  9. Subject states that he/she is status post-organ transplantation.
  10. Subject states that he/she has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
  11. Subject states that he/she has active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.
  12. As determined by the study physician, subject is taking daily medications or dietary supplements at doses that would interfere with nutrient absorption, metabolism, excretion or gastric motility.
  13. Subject states that he/she has an allergy or intolerance to any ingredient found in the study products.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00306072

Locations
United States, Minnesota
Radiant Research
Edina, Minnesota, United States, 55435
United States, Ohio
Radiant Research
Cincinnati, Ohio, United States, 45236
Sponsors and Collaborators
Ross Products
Investigators
Study Director: Jennifer A Williams, MPH Ross Products Division of Abbott Laboratories
  More Information

Additional Information:
Information in the diabetes fact sheet was valuable to the process of writing the study protocol. The fact sheet contains current prevalence data for diabetes in the US.  This link exits the ClinicalTrials.gov site

Publications:
American Diabetes Association. Economic costs of diabetes in the U.S. in 2002. Diabetes Care 26: 917-932, 2003.

ClinicalTrials.gov Identifier: NCT00306072     History of Changes
Other Study ID Numbers: CP-SRDB28
Study First Received: March 20, 2006
Last Updated: January 26, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013