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Effect of Mulberry Leaf Extract on Blood Glucose

NCT ID: NCT01385865

Last Updated: 2011-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-10-31

Brief Summary

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The purpose of this study is to evaluate the effect of mulberry leaf extract on blood glucose in subjects with impaired fasting glucose.

Detailed Description

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The purpose of this study is to evaluate the effect of mulberry leaf extract on blood glucose in subjects with impaired fasting glucose. After 2 weeks run-in period for wash-out, subjects will randomly assigned to two groups, i.e. control group (placebo) or mulberry leaf extract group. They will intake placebo or mulberry leaf extract for 4 weeks. Biomarkers will be analyzed in blood samples in 0 and 4 weeks.

Conditions

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Prediabetic State

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Mulberry leaf extract

Group Type EXPERIMENTAL

Mulberry leaf extract

Intervention Type DIETARY_SUPPLEMENT

18 tablets/day (6 tablets/serving x 3servings/day, mulberry leaf extract 336mg/1 tablet (800mg), 1-Deoxynojirimycin 4.3mg/1 g mulberry leaf extract), Duration: 4 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

18 tablets/day (6 tablets/serving x 3servings/day, lactose 511mg/1 tablet (650mg)), Duration: 4 weeks

Interventions

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Mulberry leaf extract

18 tablets/day (6 tablets/serving x 3servings/day, mulberry leaf extract 336mg/1 tablet (800mg), 1-Deoxynojirimycin 4.3mg/1 g mulberry leaf extract), Duration: 4 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

18 tablets/day (6 tablets/serving x 3servings/day, lactose 511mg/1 tablet (650mg)), Duration: 4 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Age: over 20 years
* Fasting glucose: 100mg/dl ≤ \~ ≤ 125mg/dl
* HbA1c: \< 6.5%

Exclusion Criteria

* Subject who has taken medicines, Chinese medicines and Health/Functional Foods which can affect glucose metabolism in 30 days prior to screening visit
* Subject who has taken part in other clinical trials in 30 days prior to screening visit
* Subject who is pregnant or breast feeding
* Subject who lost body weight over 4 kg in 30 days prior to screening visit
* Alcoholic
* Heavy smoker (≥ 20 cigarettes/day)
* Subject who has heart failure, coronary artery disease, uncontrolled hypertension (≥ 140/90mmHg), diabetes (fasting blood glucose ≥ 126mg/dL), renal dysfunction, liver failure, hyperthyroidism, hypothyroidism, cancer or mental disease
* Subject who has an allergy to the ingredients of study product
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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CHA University

OTHER

Sponsor Role collaborator

Ministry of Knowledge Economy, Korea

UNKNOWN

Sponsor Role collaborator

Ewha Womans University

OTHER

Sponsor Role lead

Responsible Party

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Oran Kwon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oran Kwon, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Ewha Womans University

Sung Won Kwon, MD

Role: PRINCIPAL_INVESTIGATOR

CHA University

Seok Won Park, MD

Role: PRINCIPAL_INVESTIGATOR

CHA University

Moon Jong Kim, MD

Role: PRINCIPAL_INVESTIGATOR

CHA University

Locations

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Bundang CHA Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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MLE_Biofood_2

Identifier Type: -

Identifier Source: org_study_id