A human study to evaluate safety and effective dose of Morus alba twig extract on postprandial glucose level in healthy subjects

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0001434

Enrollment

Registered

2015-04-02

Start date

2015-04-15

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : -Arm A : Consumption of high fat liquid formula with placebo at week 0. Consumption of high fat liquid formula with Morus alba twig extract (low dose) at week 1. Consumption of

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Age: 20 years = Age < 40 years 2) FBG (Fasting Blood Glucose): < 126mg/dL

Exclusion criteria

Exclusion criteria: 1) Continuous consumption of drug that affect glucose metabolism, inflammation, antioxidative capacity and lipid metabolism or dietary supplement or oriental medicine or within 4 weeks before the first visit 2) Consumption of anticoagulant within 4 weeks before the first visit 3) BMI=18.5 or BMI=30 4) Following diseases : ? Diagnosis of diabetes or fasting blood glucose = 126mg/dL at screening ? Liver dysfunction (AST, ALT level elevations more than 2.5 times the upper limit of normal) ? Renal dysfunction (serum creatinine = 1.4mg/dL) ? Cardiovascular diseases (hypertension (= 140/90 mmHg), stroke, etc.) ? Thyroid diseases, mental diseases such as depression, schizophrenia, alcoholism, drug addiction, wasting diseases such as malignant tumor etc., and severe muscular skeletal disease, asthma and allergic diseases, any condition that the principal investigator believes may put the subjects at undue risk 5) Chronic smoker (= 20 cigarettes / day) 6) Excessive exercise (= 10 hours / week) 7) Change of body weight more than 4 kg or weight control within 4 weeks before the first visit 8) Subjects with hypersensitivity to test materials 9) Participation in other human study within 4 weeks before the first visit 10) Pregnant or lactating women 11) Any condition that the principal investigator believes may put the subjects at undue risk

Design outcomes

Primary

Measure	Time frame
Blood glucose	—

Countries

Korea, Republic of

Contacts

Public ContactSoo-yeon Park

Ewha Womans University

lub486lub@naver.com+82-2-3277-4228

Outcome results