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
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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