A human study to evaluate the effect and the safety of GUCO on blood triglyceride levels

Not Applicable

Completed

• Conditions: Endocrine, nutritional and metabolic disease

• Registration Number: KCT0003872
• Lead Sponsor: Inha University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1) Subject who voluntarily agree to participate and signs informed consent form
2) Men and women over 20 years old (ratio of men and women 1:1)
3) 150 mg/dL =Blood triglyceride levels <200 mg/d

Exclusion Criteria

1) Excessive exercise (= 10 hours/week)
2) Heavy smoking (= 20 cigarettes/day)
3) Alcoholism or alcohol consumption more than 420g/week (soju 7 bottles/week)
4) BMI (Body Mass Index) <20.0 kg/m2 or =35.0 kg/m2
5) Recommended food score >36
6) Following diseases
: hyperlipidemia, diabetes, hypertension, liver disease, intestinal disease(inflammatory disease, lactose intolerance, etc), renal disease, cardiovascular disease, cerebrovascular disease, pancreatitis, cancer, thyroid disease, dementia, Parkinson's disease, depression, anorexia/bulimia, multiple sclerosis, spine injury, hypokalemia, uerine disease, etc.
7) Following medicines within 1 month before the first visit or during study,
: lipid-lowering agents(ursodeoxycholic acid), statin, etc), blood glucose-lowering drugs, antibiotics, drugs on intestine function, hormones, oral contraceptives, appetite depressants/stimulant, diuretics, beta-blockers, contraceptives, steroids, tricyclic antidepressants, laxatives, antidepressants, et al. But subjects taking thiazide or beta-blockers with no dose change for 1 year and during study can be enrolled.
8) Continuous consumption of oriental herbal medicine within 1 month before the first visit
9) Continuous consumption of dietary supplements with efficacy on blood lipids, blood glucose, body fat metabolism within 1 month before the first visit (phytosterol, omega-3 fatty acids, psyllium husk, aloe, chitosan, onion extract, nondigestible maltodextrin, dietary fiber, etc)
10) Subjects with hypersensitivity to test materials
11) Participation in other human study within one month before the first visit
12) Pregnant or lactating women
13) Any condition that the principal investigator believes may put the subjects at undue risk

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood triglyceride

Secondary Outcome Measures

Name	Time	Method
Total cholesterol, LDL-C, HDL-C, VLDL-C;Apo B100, Apo CII, fasting blood glucose, insulin;Anthropometric measurements;0, 12?