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Mulberry Leaf Extract and Blood Glucose Control in Diabetics

NCT01305434 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-02-04

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus Type 2

Interventions

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.

Sponsors & Collaborators

  • Craig, Nancy, M.D.

    lead INDIV

Principal Investigators

  • Nancy V Craig, MDCM

  • William R Craig, MD CM · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2014-10-31
Completion
2014-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01305434 on ClinicalTrials.gov