Mulberry Leaf Extract and Blood Glucose Control in Diabetics

February 2, 2015 updated by: Nancy Craig, Craig, Nancy, M.D.

Randomized Double Blind Cross Over Trial to Examine the Effect of Mulberry Leaf Extract on Post Prandial Glucose in Type 2 Diabetics

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5B 2Y1
        • Hope Medical Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Placebo then mulberry leaf
These patients receive placebo for two weeks, then 1 week washout, then two weeks of mulberry leaf extract.
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 Names:
  • Mulberry Zuccarin, 400 mg tablets. New Nordic (Sweden)
Other: Mulberry leaf then placebo
These patients receive mulberry leaf extract for two weeks, then 1 week washout, then two weeks of placebo.
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 Names:
  • Mulberry Zuccarin, 400 mg tablets. New Nordic (Sweden)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in 2 hour post prandial blood glucose
Time Frame: 6 weeks
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
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of subjects with adverse changes in creatinine, AST, ALT, and blood pressure due to intervention
Time Frame: 6 weeks
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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Craig, Nancy, M.D.

Investigators

  • Principal Investigator: Nancy V Craig, MDCM
  • Study Director: William R Craig, MD CM, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

February 24, 2011

First Submitted That Met QC Criteria

February 25, 2011

First Posted (Estimate)

February 28, 2011

Study Record Updates

Last Update Posted (Estimate)

February 4, 2015

Last Update Submitted That Met QC Criteria

February 2, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MLE-DM2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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