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Completed

NCT Number: NCT01385865

Effect of Mulberry Leaf Extract on Blood Glucose

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

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bundang CHA Medical Center

Seongnam-si, Gyeonggi-do, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Mulberry Leaf Extract

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

Dietary Supplement

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

Primary outcomes

  1. Blood glucose change with meal tolerance test

    Time frame: 0wk

Secondary outcomes

  1. Blood glucose change with meal tolerance test

    Time frame: 4wk

  2. Insulin and C-peptide changes with meal tolerance test

    Time frame: 0, 4 wk

  3. Fasting blood glucose

    Time frame: 0, 4 wk

  4. Insulin

    Time frame: 0, 4wk

  5. C-peptide

    Time frame: 0, 4wk

  6. Glycated albumin

    Time frame: 0, 4wk

  7. High sensitivity C-reactive protein

    Time frame: 0, 4wk

  8. Oxidized low-density lipoprotein

    Time frame: 0, 4wk

  9. Malondialdehyde

    Time frame: 0, 4wk

  10. Lipid profile (triglyceride, total cholesterol, low-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, high-density lipoprotein cholesterol)

    Time frame: 0, 4wk

Sponsors and collaborators

Lead sponsor

Ewha Womans University

Other

Collaborators

  • CHA University
  • Ministry of Knowledge Economy, Korea

Registry information

Official study title

Effect of Mulberry Leaf Extract on Blood Glucose in Subjects With Impaired Fasting Glucose

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 30, 2011
Registry last updated
Oct 28, 2011

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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