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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Canadian Diabetes Association
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT00728403
First received: August 1, 2008
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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).


Condition Intervention Phase
Diabetes Mellitus Type 2
Dietary Supplement: American Ginseng (Panax quinquefolius L.) and Korean Red Ginseng (steamed Panax C.A. Meyer)
Dietary Supplement: American Ginseng (Panax quinquefolius L.)
Dietary Supplement: Wheat Bran
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Long Term Metabolic and Therapeutic Effects of Combined Treatment of American Ginseng (Panax Quinquefolius L.) Extract and Korean Red Ginseng (Steamed Panax C.A. Meyer) Extract in the Treatment of Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • HbA1c levels and insulin sensitivity index using 3 different indices: ISI, HOMA, QUICKI [ Time Frame: Weeks -4, 0, 6, 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cholesterol, triglycerides, fasting & post-prandial blood glucose and insulin, C-reactive protein, lipid peroxidation, blood pressure, endothelial function, body fat composition [ Time Frame: Weeks -4, 0, 6, 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: September 2008
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
American Ginseng and American Red Ginseng Capsules
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
Experimental: 2
American Ginseng Capsules
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
Placebo Comparator: 3
Placebo Capsules
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

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • presence of type 2 diabetes (at least 1 year) as defined by A1c between ≥6.5% and ≤8.1%, at recruitment,
  • treatment with diet or oral hypoglycemic medication be unchanged starting at least 2 months prior to the beginning of the study (at recruitment, week -8)
  • between the age of 40 and 75 years
  • systolic blood pressure <140 and diastolic blood pressure <90
  • clinically euthyroid (measuring T3 and T4)
  • normal renal and liver functions
  • post-menopausal or non-pregnant women (Post-menopausal includes: those females with more than a year of cessation of menstruation)
  • a negative result on a pregnancy test administered at screening
  • subjects taking an effective form of birth control (example: condom, abstinence, etc.)
  • willing to comply with the study protocol and sign a consent form

Exclusion Criteria:

  • individuals with bleeding disorders
  • individuals with allergies to nitroglycerin
  • planned surgery, pregnancy or breastfeeding
  • taking insulin; clinically significant diabetes complications (retinopathy, nephropathy, or neuropathy); serum triglycerides ≥ 4.5 mmol/L
  • increased A1c level of more than 2% from baseline during the study
  • history of angina or heart attack
  • use of ginseng or any natural health products with glucose modulating and/or anti-platelet activity within 2 months
  • BMI > 35 kg/m2 including a weight fluctuation of + 2kg during treatment periods
  • smoke cigarettes; alcohol intake > 2 drinks/day
  • the presence of any conditions which, in the opinion of the investigator, might jeopardize the health and safety of the subject or study personnel or adversely affect the study results, if the subject participated in the study
  • Subjects taking Warfarin or Coumadin, prescription NSAIDs, chronic use of high-dose (>81mg) non-prescription NSAIDs, or selective serotonin reuptake inhibitors and monoamine oxidase inhibitors, or sympathomimetics or medications affecting nitric oxide levels, or any known or suspected sensitivity to any of the ingredients in the test product or placebo cannot participate in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00728403

Locations
Canada, Ontario
Clinical Nutrition and Risk Factor Modification Centre
Toronto, Ontario, Canada, M5C 1N8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Canadian Diabetes Association
Investigators
Principal Investigator: Vladimir Vuksan, PhD Clinical Nutritian and Risk Factor Modification Centre
Principal Investigator: Alexandra Jenkins, PhD Clinical Nutrition and Risk Factor Modificatrion Centre
Principal Investigator: Lawerence Leiter, MD St. Michaels Hospital
Principal Investigator: Leanne De Souza, M.Sc. Clinical Nutrition and Risk Factor Modificatrion Centre
  More Information

No publications provided

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT00728403     History of Changes
Other Study ID Numbers: 122380
Study First Received: August 1, 2008
Last Updated: February 12, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 30, 2014