Effect of Different Doses of Salacinol Extract on Glycemic and Insulinemic Response in Patients With Type 2 Diabetes
NCT ID: NCT00306072
Last Updated: 2010-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
82 participants
INTERVENTIONAL
2005-06-30
2005-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Interventions
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nutritional herbal extract from Salacia oblonga
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Ross Products
INDUSTRY
Principal Investigators
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Jennifer A Williams, MPH
Role: STUDY_DIRECTOR
Ross Products Division of Abbott Laboratories
Locations
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Radiant Research
Edina, Minnesota, United States
Radiant Research
Cincinnati, Ohio, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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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.
Other Identifiers
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CP-SRDB28
Identifier Type: -
Identifier Source: org_study_id
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