Human study for investigating the effectiveness and safety of black ginseng ethanol extract(GBG05-FF) in adults with impaired fasting glucose

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002242

Enrollment

Registered

2017-02-23

Start date

2017-03-23

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 4) HbA1c=5.7% and =6.4%

Exclusion criteria

Exclusion criteria: 1) Continuous consumption of drug, oriental medicine, dietary supplement those that affect glucose metabolism 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 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) high intensity exercise regularly (> 10 hours / week) 6) Excessive smoker (= 20 cigarettes / day) 7) Alcoholics or those who Usually drinking more than 210 g of alcohol a week (soju about 3.5 bottles/week, 3.5 cup/day) 8) Subjects with hypersensitivity to test materials 9) Participation in other human study within 1 month 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
Glucose, Insulin, C-peptide, HbA1c, Index of insulin resistance and sensitivity(Homeostasis model assessment-insulin resistance(Homa-ir), Quantitative insulin sensitivity check index(Quicki))	—

Secondary

Measure	Time frame
Triglycerides(TG), Total cholesterol(TC), Low-density lipoprotein cholesterol(LDL-C), High-density lipoprotein cholesterol(HDL-C), Very low-density lipoprotein cholesterol(VLDL-C), Aspartate aminotransferase(AST), Alanine aminotransferase(ALT)	—

Countries

Korea, Republic of

Contacts

Public ContactJaeheon Kang

Inje University Seoul Paik Hospital

fmleader@nuri.net+82-2-2272-0960

Outcome results