Metabolic and Therapeutic Effects of American and Korean Red Ginseng in the Treatment of Type 2 Diabetes

NCT00728403 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-07-31

No results posted yet for this study

Summary

The study is a 2 phase double blind randomized placebo control trial. The objective is to asses the metabolic and therapeutic effects of American Ginseng (Panax quinquefolius L.) extract and Korean Red Ginseng (steamed Panax C.A. Meyer) extract in the management of type 2 diabetes in a 12 week period. One Hundred and twenty subjects with type 2 diabetes (hyperglycemia key inclusion criteria: HbAlc≥6.5% - ≤ 8.1% ) will participate in the study (36 men and 36 post-menopausal women).

Conditions

  • Diabetes Mellitus Type 2

Interventions

DIETARY_SUPPLEMENT

American Ginseng (Panax quinquefolius L.) and Korean Red Ginseng (steamed Panax C.A. Meyer)

1.5 grams American Ginseng and 1.5 grams Korean Red Ginseng are to be taken in capsulated form. Two capsules are taken with every meal, for a total of 6 capsules per day for 12 weeks

DIETARY_SUPPLEMENT

American Ginseng (Panax quinquefolius L.)

3 grams of American Ginseng is to be taken in capsulated form. Two capsules are taken with every meal, for a total of 6 capsules per day for 12 weeks

DIETARY_SUPPLEMENT

Wheat Bran

3 grams of Wheat Bran is to be taken in capsulated form. Two capsules are taken with every meal, for a total of 6 capsules per day for 12 weeks

Sponsors & Collaborators

  • Canadian Diabetes Association

    collaborator OTHER
  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • Vladimir Vuksan, PhD · Clinical Nutritian and Risk Factor Modification Centre

  • Alexandra Jenkins, PhD · Clinical Nutrition and Risk Factor Modificatrion Centre

  • Lawerence Leiter, MD · St. Michaels Hospital

  • Leanne De Souza, M.Sc. · Clinical Nutrition and Risk Factor Modificatrion Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00728403 on ClinicalTrials.gov