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NCT Number: NCT01305434

Mulberry Leaf Extract and Blood Glucose Control in 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.

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Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hope Medical Clinic

Edmonton, Alberta, T5B 2Y1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mulberry leaf extract effect on post prandial blood glucose

Dietary Supplement

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)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Craig, Nancy, M.D.

Indiv

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 28, 2011
Registry last updated
Feb 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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