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

Phase 1

Completed

• Conditions: Diabetes Mellitus

• Registration Number: NCT00306072
• Lead Sponsor: Ross Products

Brief Summary

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.

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.

Study Timeline

• Study Start: 2005-06
• Study Completion: 2005-09
• Status Verified: 2006-03
• Study First Submitted: 2006-03-20
• Study First Submitted QC: 2006-03-20
• Study First Posted: 2006-03-22
• Last Update Submitted: 2010-01-26
• Last Update Posted: 2010-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
The primary variable to be measured was positive AUC (0-180 minutes) for plasma glucose.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Radiant Research; 🇺🇸 Cincinnati, Ohio, United States