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Diabetes MellitusPhase 1/2NCT00306072

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

A Phase 1/2 study testing nutritional herbal extract from Salacia oblonga in people with Diabetes Mellitus, run by Ross Products at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus
What is being tested?
nutritional herbal extract from Salacia oblonga
How many people
82 participants
Where
2 sitesUnited States
Study dates
Jun 2005to Sep 2005
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 13Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Radiant Research

    Cincinnati, Ohio, 45236

  • Radiant Research

    Edina, Minnesota, 55435

Other trials in United States

About this study

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.

Read the 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.

Being tested
nutritional herbal extract from Salacia oblonga
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nutritional herbal extract from Salacia oblongaDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

  1. The secondary variables to be measured were:

  2. · Positive AUC (0 to 120 minutes) for plasma and serum glucose and positive AUC (0 to 180 minutes) for serum glucose

  3. · Adjusted peak value for plasma and serum glucose

  4. · Adjusted peak value for serum insulin

  5. · Positive AUC 0-180 (0 to 120) minutes for serum insulin

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2006 (estimated)
  2. Study startJun 2005
  3. Study completionSep 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Enrolment
82 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00306072
Sponsor's protocol ID
CP-SRDB28
Status last verified
Mar 2006
First submitted
20 Mar 2006
Last updated
27 Jan 2010
Results posted
No

Publications

  • 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.

    PubMed 12610059

  • 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.

    PubMed 15975493

  • 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.

    PubMed 8366922

  • 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.

    PubMed 11281771

  • 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.

    PubMed 15635348

  • 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.

    PubMed 10748716

  • 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.

    PubMed 9742976

  • 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.

    PubMed 12738192

  • 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.

    PubMed 1951155

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing nutritional herbal extract from Salacia oblonga in people with Diabetes Mellitus, run by Ross Products at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary variable to be measured was positive AUC (0-180 minutes) for plasma glucose.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00306072, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2010.

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