Verification of the effects of continuous intake of the test food on visceral fat

UMIN ID: UMIN000052958

Registered date:01/12/2023

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: healthy adult men and women
• Date of first enrollment: 2023/12/20
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Continuous intake of the test food for 12 weeks
Continuous intake of control food for 12 weeks

Outcome(s)

• Primary Outcome: visceral fat area
• Secondary Outcome: Weight, BMI, waist circumference, hip circumference

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 60years-old
• Gender: Male and Female
• Exclude criteria: 1.individuals using medical products. 2.existing or past illnesses such as skin diseases 3.who are likely to exhibit severe allergic symptoms to test foods or metals. 4.Who have taken drugs such as fat absorption inhibitors or appetite suppressants that affect body weight and body fat, drugs related to obesity improvement, performed any treatment for slimming purposes, or used quasi-drugs ,those who have taken food for specified health uses, health foods or supplements in the past 1 months 5.severe anemia 6. Currently pregnant or breastfeeding. Or those who may be affected during the exam period. 7. Who have Serious diseases such as liver, kidney, and heart diseases, 8.who are currently suffering from any serious or chronic disease and are undergoing medication treatment, outpatient treatment, diet therapy, or exercise therapy. 9.using health foods, supplements, or medicines that may affect test results 10.current disease or history of drug dependence or alcohol dependence 11.who are currently hospitalized for mental disorders (depression, etc.), sleep disorders, etc., or who have a history of mental disorders in the past. 12.whose daily rhythms are irregular due to night work or shift work, etc. 13.whose lifestyle may change from the pre-test to the test period 14.extremely irregular lifestyle habits such as eating and sleeping 15.who have extreme picky eating habits. 16.who participated in other clinical studies in the past 3 months to the date of consent acquisition, or those who plan to participate in other clinical trials (research) during the study period. 17.who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. 18.who have difficulty completing records on various survey forms 19. Persons judged to be unsuitable as subjects based on clinical test values and measured values at the time of SCR 20. Any other person deemed unsuitable as a subject by the principal investigator.

Related Information

• Primary Sponsor: BHN Co., Ltd
• Source(s) of Monetary Support: kikaijima harb Farm Co.,LTD