Mulberry Leaf Extract and Blood Glucose Control in Diabetics

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Craig, Nancy, M.D..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Craig, Nancy, M.D.
ClinicalTrials.gov Identifier:
NCT01305434
First received: February 24, 2011
Last updated: March 1, 2011
Last verified: March 2011
  Purpose

Mulberry leaf teas or extracts are used as a natural remedy for diabetes in some countries. Animal studies have shown some effect of mulberry leaf extract on blood glucose. The purpose of this trial is to assess the effect of mulberry leaf extract on type 2 diabetics, by measuring blood glucose two hours after eating a meal and taking a capsule containing either mulberry leaf extract or a placebo.


Condition Intervention Phase
Diabetes Mellitus Type 2
Dietary Supplement: Mulberry leaf extract effect on post prandial blood glucose
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Double Blind Cross Over Trial to Examine the Effect of Mulberry Leaf Extract on Post Prandial Glucose in Type 2 Diabetics

Resource links provided by NLM:


Further study details as provided by Craig, Nancy, M.D.:

Primary Outcome Measures:
  • change in 2 hour post prandial blood glucose [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Success would be a change in pc glucose of -1.5 units (SI) greater than 70% of the time or in more than 70% of subject, and no increased incidence of hypoglycemia with the intervention


Secondary Outcome Measures:
  • number of subjects with adverse changes in creatinine, AST, ALT, and blood pressure due to intervention [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Because mulberry leaf tea has been shown to contain cadmium which can have renal or hepatotoxic effects, renal function, liver function, and blood pressure will be monitored.


Estimated Enrollment: 20
Study Start Date: September 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Mulberry leaf extract effect on post prandial blood glucose

    Mulberry leaf extract (400 mg, Mulberry Zuccarin, New Nordic) or placebo will be administered with meals to type 2 diabetics. Half the patients will receive mulberry leaf extract for the first two weeks and half will receive placebo. Following a one week wash out period, the interventions will be reversed for another 2 weeks, followed by a final wash out period. Subjects will keep diaries of food, exercise, daily fasting glucose, and at least one 2 hour pc glucose per day for the 6 weeks of the trial.

    Baseline renal function blood work and urine, liver function blood work, hemoglobin A1C, weight, and blood pressure will be done. These will be repeated at the end of each subject's 6 weeks in the trial. In addition, blood pressure will be checked with the distribution of the each 2 week batch of medications.

    Other Name: Mulberry Zuccarin, 400 mg tablets. New Nordic (Sweden)
Detailed Description:

Patients will participate in a double blind randomized cross over trial for 6 weeks. Four 2 weeks, half of the type 2 diabetic patients will receive mulberry leaf capsules three times per day with meals (made from Mulberry Zuccarin tablets - New Nordic, 400 mg of mulberry leaf extract per tablet) and half will receive placebo capsules. Following a one week wash out period, the treatments administered to each group will be reversed for the next 2 weeks, and data will continue to be gathered for a final wash out week. Patients will keep a diary of food, exercise, and fasting glucose each morning as well as at least one 2 hour pc glucose each day. Weight, hemoglobin A1C, liver function tests, and renal function tests will be done at baseline and at the end of the 6 weeks. As well, blood pressure will be monitored when the 2 weekly batches of medication are distributed, and at the end of the 6 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • baseline hemoglobin A1C greater than or equal to 7.5 or fasting glucose greater than 7 (SI units)

Exclusion Criteria:

  • on insulin
  • history of hepatic or renal disease
  • pregnant or nursing women
  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: NCT01305434

Contacts
Contact: Nancy V Craig, MDCM 780 443-0200 wncraig@telusplanet.net

Locations
Canada, Alberta
Hope Medical Clinic Not yet recruiting
Edmonton, Alberta, Canada, T5B 2Y1
Contact: Nancy V Craig, MDCM    780-479-1944    wncraig@telusplanet.net   
Principal Investigator: Nancy V Craig, MDCM         
Sponsors and Collaborators
Craig, Nancy, M.D.
Investigators
Principal Investigator: Nancy V Craig, MDCM
Study Director: William R Craig, MD CM University of Alberta
  More Information

Additional Information:
Publications:

Responsible Party: Dr. Nancy Craig, unaffiliated
ClinicalTrials.gov Identifier: NCT01305434     History of Changes
Other Study ID Numbers: MLE-DM2
Study First Received: February 24, 2011
Last Updated: March 1, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Craig, Nancy, M.D.:
diabetes mellitus type 2
mulberry leaf extract
post prandial blood glucose

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

ClinicalTrials.gov processed this record on August 19, 2014