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Black camin extract powder health functional food human study of evaluate for body fat reduction

A 12-week randomized, double-blind, placebo-controlled human study to evaluate the effectiveness and safety of Black Cumin Powder in reducing body of fat

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0008445
Enrollment
88
Registered
2023-05-19
Start date
2023-02-07
Completion date
Unknown
Last updated
2024-07-23

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 : Test group: oral intake of 2 capsules once a day Black cumin extract powder 1,000mg/1day (900mg/1day as black cumin extract powder) Total intake peri

Sponsors

ARI BnC
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
· DEXA – body fat mass (kg), body fat percentage (% BF)

Secondary

MeasureTime frame
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

Countries

Korea, Republic of

Contacts

Public ContactKyoung hwa Won

Korea National Sport University

wkh116@naver.com+82-2-410-6898

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026