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

NCT00306072 | Completed Phase 1

• 1 other identifier: CP-SRDB28
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

• 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

Interventions

nutritional herbal extract from Salacia oblonga DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ross Products: lead

Study Sites (2)

Radiant Research

Edina, Minnesota, 55435, United States

Location

Radiant Research

Cincinnati, Ohio, 45236, United States

Location

Related Publications (9)

• Hogan P, Dall T, Nikolov P; American Diabetes Association. Economic costs of diabetes in the US in 2002. Diabetes Care. 2003 Mar;26(3):917-32. doi: 10.2337/diacare.26.3.917.

  PMID: 12610059 BACKGROUND

• Collene AL, Hertzler SR, Williams JA, Wolf BW. Effects of a nutritional supplement containing Salacia oblonga extract and insulinogenic amino acids on postprandial glycemia, insulinemia, and breath hydrogen responses in healthy adults. Nutrition. 2005 Jul-Aug;21(7-8):848-54. doi: 10.1016/j.nut.2004.11.018.

  PMID: 15975493 BACKGROUND

• Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.

  PMID: 8366922 BACKGROUND

• Ghavami A, Johnston BD, Pinto BM. A new class of glycosidase inhibitor: synthesis of salacinol and its stereoisomers. J Org Chem. 2001 Apr 6;66(7):2312-7. doi: 10.1021/jo001444g.

  PMID: 11281771 BACKGROUND

• Heacock PM, Hertzler SR, Williams JA, Wolf BW. Effects of a medical food containing an herbal alpha-glucosidase inhibitor on postprandial glycemia and insulinemia in healthy adults. J Am Diet Assoc. 2005 Jan;105(1):65-71. doi: 10.1016/j.jada.2004.11.001.

  PMID: 15635348 BACKGROUND

• Matsuda H, Murakami T, Yashiro K, Yamahara J, Yoshikawa M. Antidiabetic principles of natural medicines. IV. Aldose reductase and qlpha-glucosidase inhibitors from the roots of Salacia oblonga Wall. (Celastraceae): structure of a new friedelane-type triterpene, kotalagenin 16-acetate. Chem Pharm Bull (Tokyo). 1999 Dec;47(12):1725-9. doi: 10.1248/cpb.47.1725.

  PMID: 10748716 BACKGROUND

• Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53.

  PMID: 9742976 BACKGROUND

• Wolf BW, Weisbrode SE. Safety evaluation of an extract from Salacia oblonga. Food Chem Toxicol. 2003 Jun;41(6):867-74. doi: 10.1016/s0278-6915(03)00038-3.

  PMID: 12738192 BACKGROUND

• Wolever TM, Jenkins DJ, Jenkins AL, Josse RG. The glycemic index: methodology and clinical implications. Am J Clin Nutr. 1991 Nov;54(5):846-54. doi: 10.1093/ajcn/54.5.846.

  PMID: 1951155 BACKGROUND

Related Links

• 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.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jennifer A Williams, MPH

  Ross Products Division of Abbott Laboratories

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 20, 2006
• First Posted: March 22, 2006
• Study Start: June 1, 2005
• Study Completion: September 1, 2005
• Last Updated: January 27, 2010

Record last verified: 2006-03

Locations

US (2)