Mulberry Leaf Extract and Blood Glucose Control in Diabetics

Phase 1

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Dietary Supplement: Mulberry leaf extract effect on post prandial blood glucose

• Registration Number: NCT01305434
• Lead Sponsor: Craig, Nancy, M.D.

Brief Summary

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.

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 Timeline

• Study First Submitted: 2011-02-24
• Study First Submitted QC: 2011-02-25
• Study First Posted: 2011-02-28
• Study Start: 2011-09
• Primary Completion: 2014-10
• Study Completion: 2014-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-02
• Last Update Posted: 2015-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo then mulberry leaf	Mulberry leaf extract effect on post prandial blood glucose	These patients receive placebo for two weeks, then 1 week washout, then two weeks of mulberry leaf extract.
Mulberry leaf then placebo	Mulberry leaf extract effect on post prandial blood glucose	These patients receive mulberry leaf extract for two weeks, then 1 week washout, then two weeks of placebo.

Primary Outcome Measures

Name	Time	Method
change in 2 hour post prandial blood glucose	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 Outcome Measures

Name	Time	Method
number of subjects with adverse changes in creatinine, AST, ALT, and blood pressure due to intervention	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.

Trial Locations

Locations (1)

Hope Medical Clinic; 🇨🇦 Edmonton, Alberta, Canada