Black camin extract powder health functional food human study of evaluate for body fat reductio
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0008445
- Lead Sponsor
- ARI BnC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 88
1)A person between the ages of 19 and 65 who is healthy and capable of normal physical activity
2) Those who are normal (18.5 ~ 24.9kg/m2) to overweight (25.0 ~ 29.9kg/m2) based on body mass index (BMI) and do not take medication
? If some (ethically permissible range) of persons with a BMI of 30.0 to 34.9 kg/m2 are included, those who take medication or need a prescription must
be excluded.
1) Those who did not sign the subject consent form
2) Those who participated in other human application tests within 2 months before the screening test
3) A person whose body weight has changed by 5-10% within 3 months, and whose weight gain or loss is 5 kg or more
4) Those who have undergone obesity surgery within the last year
5) Those who have undergone surgery within the last 6 months
6) Those who are receiving or have received psychotropic drug treatment and psychological treatment due to mental illness (depression, schizophrenia, etc.)
7) A person diagnosed with cardiovascular disease, arrhythmia, heart failure, myocardial infarction, or cerebrovascular disease, or a person with a history of using a pacemaker
8) Subjects undergoing drug treatment for diabetes or those with fasting blood sugar of 154 mg/dL or higher
9) Patients with gastroenteritis (Crohn's disease) / gastric resection / irritable bowel syndrome
10) Chronic inflammation (kidney, liver, pancreas) and infectious diseases, hypertension (systolic/diastolic 160/100mmHg or higher)
11) Those with a history of heart disease or cancer
12) Thyroid disease and those taking thyroid drug substitutes
13) Patients with malabsorption syndrome/autoimmune disease
14) Patients with liver failure and renal failure
15) Those who take dietary supplements or drugs that can affect blood sugar and lipid metabolism, body composition, and eicosanoid production (e.g. salicylates, product milk)
16) Patients with anemia/porphyria
17) Those suffering from pancreatic disease, those with a history of eating disorders
18) Pregnant or lactating women
19) Women within 6 months of giving birth
20) Those taking anti-obesity drugs
21) drug addict
22) Those who are taking blood sugar lowering drugs, insulin, or diabetes medications
23) Those taking drugs that affect energy metabolism, blood sugar, appetite, and gastrointestinal activity
24) Those who are taking drugs that affect carbohydrate and lipid metabolism, weight and hormones
25) Those taking immunosuppressants, proton pump inhibitors (PPI), H2 blockers, and non-steroidal anti-inflammatory drugs
26) Those taking blood cholesterol improving health functional food
27) Women who do not use the correct method of contraception
28) Those who have been on a diet for the past 3 years
29) Those who have participated in a weight loss program within the last 3 months
30) Those who consume excessive alcohol (more than 40g per day for men and more than 20g per day for women)
31) Excessive smokers (more than 25 cigarettes/day)
32) Those who consume excessive caffeine (daily intake of 400 mg or more)
33) There are side effects to vegetable oils
34) Those with serum creatinine of 1.5 mg/dL or higher
35) A person whose AST or ALT level is three times or more than the maximum normal level
36) Those who are judged unsuitable for the human body application test by the tester
37) Hepatitis B or C carriers
38) Those who are judged unfit to participate in the test by the test director for other reasons
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method · DEXA – body fat mass (kg), body fat percentage (% BF)
- Secondary Outcome Measures
Name Time Method Fat(kg), Fat(%);Weight, body mass index (BMI), basal metabolic rate;Waist circumference, hip circumference, WHR (waist/hip ratio);abdominal CT, DEXA-lean mass, LAP index;blood lipid, secreted hormone