Human study for investigating the effectiveness and safety of Mulberry ethanol extract in adults whose fasting glucose is borderline.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002525

Enrollment

Registered

2017-11-10

Start date

2017-09-11

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 : Visit 1(week -2), subject who voluntarily signs on the written informed consent is reviewed according to inclusion-exclusion criteria. After two-week run-in period, selected subje

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Subject who voluntarily agrees to participate and sign in informed consent form 2) Adults (Age=20 years) 3) Fasting blood glucose=100 mg/dL and =125 mg/dL

Exclusion criteria

Exclusion criteria: 1) Continuous consumption of drug, oriental medicine, dietary supplement those that affect glucose metabolism, antioxidant within 1 month before the first visit 2) Following diseases : - cardiac failure, coronary artery disease, uncontrolled hypertension (systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg), hyperlipidemia, diabetes (fasting blood glucose =126 mg / dL), renal dysfunction (rising more than 1.5 times the upper limit of normal creatinine) Hepatic dysfunction (ALT, AST three times higher than normal upper limit), hypothyroidism, chronic gastrointestinal disorders, gastrointestinal surgery, acute and chronic inflammatory diseases, malignant tumors, Mental diseases, chronic or serious patients who need to take medication in the long term 3) BMI=18.5 kg/m2 or BMI=30 kg/m2 4) Subjects who controlling body weight or subjects who have changed of body weight more than 10 percent within 6 months before the first visit 5) Excessive smoker (= 20 cigarettes / day) 6) Alcoholics 7) Subjects with hypersensitivity to test materials 8) Participation in other human study within 1 month before the first visit 9) Pregnant or lactating women 10) Any condition that the principal investigator believes may put the subjects at undue risk

Design outcomes

Primary

Measure	Time frame
Glucose, Insulin	—

Secondary

Measure	Time frame
Index of insulin resistance and sensitivity (HOMA-IR)	—

Countries

Korea, Republic of

Contacts

Public ContactDoori Choi

Bundang Jesaeng Hospital

biomedi7@daum.net+82-31-779-5077

Outcome results