Research on Human Application to Evaluate Neutral Fat Improvement Effect and Safety of Leaf Casting Extracts

Not Applicable

Recruiting

• Conditions: Endocrine, nutritional and metabolic diseases

• Registration Number: KCT0006990
• Lead Sponsor: Seoul National University of Science and Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-01-07
• Last Update Posted: 8 March 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1) Those who agreed to participate in this study and signed a written consent form
2) Adult men and women over the age of 20
3) Those whose blood triglyceride level is less than 200 mg/d

Exclusion Criteria

1) Those who have the following diseases or have a history
- Hyperlipidemia, uncontrolled diabetes/hypertension, liver disease, kidney disease, intestinal disease (including inflammatory bowel disease and lactose intolerance), cardiovascular/cerebrovascular disease, malignant tumor, gastrointestinal disease requiring treatment, thyroid disease, pancreatitis, multiple Multiple sclerosis, anemia, dementia, depression, anorexia, bulimia, asthma, other allergic diseases, etc.
2) If you have taken the following medications within 3 months of your first visit or are expected to take them during the study period
- Drugs that affect fat absorption or lipid metabolism (lipid-lowering drugs, etc.), hypoglycemic agents, drugs that affect insulin secretion/activity, hormones, anticoagulants, etc.
3) If you are on hormone replacement therapy
4) If you have continuously taken herbal medicines within 2 months of your first visit
5) Those who donated blood within 3 weeks of their first visit
6) Those who have continuously consumed health functional foods (plant sterols, omega-3 fatty acids, psyllium husk, aloe, etc.) that can affect blood sugar, lipid, and body fat metabolism within 1 month of the first visit
7) Those with good meal quality (Recommended Food Score > 36)
8) Vegetarian
9) Alcoholics or those who usually consume more than 420 g/week of alcohol (about 7 bottles/week of soju)
10) Those with a body mass index (BMI) of 23 kg/m2 or less or 35 kg/m2 or more
11) Those who are losing weight or who have had a weight change of 10% or more within 3 months of their first visit
12) Those who regularly engage in high-intensity exercise (=10 hours/week)
13) Excessive smokers (=20 cigarettes/day)
14) Those who participated in another clinical study within 1 month of the first visit
15) Pregnant or lactating women, those who plan to become pregnant
16) Those who have hypersensitivity to the ingredients contained in the test/control food or who have experienced a severe food allergy reaction
17) Those who are judged inappropriate by the researcher to participate in this research

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Triglycerides

Secondary Outcome Measures

Name	Time	Method
APO-B 100