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

NCT00728403 | Unknown Phase 2

• 1 other identifier: 122380
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• HbA1c levels and insulin sensitivity index using 3 different indices: ISI, HOMA, QUICKI

  Weeks -4, 0, 6, 12

Secondary Outcomes (1)

• Cholesterol, triglycerides, fasting & post-prandial blood glucose and insulin, C-reactive protein, lipid peroxidation, blood pressure, endothelial function, body fat composition

  Weeks -4, 0, 6, 12

Study Arms (3)

1

EXPERIMENTAL

American Ginseng and American Red Ginseng Capsules

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

2

EXPERIMENTAL

American Ginseng Capsules

Dietary Supplement: American Ginseng (Panax quinquefolius L.)

3

PLACEBO COMPARATOR

Placebo Capsules

Dietary Supplement: Wheat Bran

Interventions

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

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

1

American Ginseng (Panax quinquefolius L.) DIETARY_SUPPLEMENT

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

2

Wheat Bran DIETARY_SUPPLEMENT

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

3

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unity Health Toronto: lead
• Canadian Diabetes Association: collaborator

Study Sites (1)

Clinical Nutrition and Risk Factor Modification Centre

Toronto, Ontario, M5C 1N8, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Asian ginseng; Dietary Fiber

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2008
• First Posted: August 5, 2008
• Study Start: September 1, 2008
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: July 31, 2015

Record last verified: 2015-07

Locations

CA (1)