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Effect of Mulberry Leaf Extract on Blood Glucose

Ewha Womans University logo

Ewha Womans University

Status

Completed

Conditions

Prediabetic State

Treatments

Dietary Supplement: Mulberry leaf extract
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01385865
MLE_Biofood_2

Details and patient eligibility

About

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

Full description

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.

Enrollment

40 estimated patients

Sex

All

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

40 participants in 2 patient groups, including a placebo group

Mulberry leaf extract
Experimental group
Treatment:
Dietary Supplement: Mulberry leaf extract
Placebo
Placebo Comparator group
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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