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

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.

Inclusion criteria

• Subject has type 2 diabetes mellitus verified by prescription of oral antihyperglycemic medications.
• Subject is 18 to 75 years of age, inclusively.
• 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.
• Subject has a body mass index (BMI) of 18 - 35 kg/m2.
• 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

• Subject uses exogenous insulin for glucose control.
• Subject states that he/she has an infection (requiring medication or hospitalization).
• Subject states that he/she has current hepatic disease.
• Subject states that he/she has had surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks.
• Subject has a first-degree relative enrolled in the current study.
• Subject states that he/she has an active malignancy (subjects with cutaneous malignancies, other than melanoma, may be included in the study).
• Subject states that he/she has had a significant cardiovascular event < 12 weeks prior to study entry.
• Subject states that he/she has end stage organ failure, including clinically advanced renal disease as assessed by the study physician.
• Subject states that he/she is status post-organ transplantation.
• Subject states that he/she has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
• Subject states that he/she has active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.
• 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.
• Subject states that he/she has an allergy or intolerance to any ingredient found in the study products.