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

UMIN ID: UMIN000051633

Registered date:23/07/2023

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: healthy adult men and women
• Date of first enrollment: 2023/07/24
• 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.show severe allergy to the test food 2.with an implantable defibrillator such as a pacemaker 3.have a current or a history of skin diseases, 4.develop severe allergy to metals 5.with severe anemia 6.Currently pregnant or breastfeeding. Or a person who may have such a possibility during the test period 7.Liver/kidney/cardiac disease, respiratory disorder, endocrine disorder, metabolic disorder, neurological disorder, consciousness disorder, diabetes, brain disease, malignant tumor, immune disease, serious disease such as heart disease, thyroid disease, other metabolic diseases Those who have a serious current disease such as disease or a history 8.are currently undergoing drug treatment, outpatient treatment, diet therapy, or exercise therapy for any serious or chronic disease. 9.are aware of dysmenorrhea or PMS symptoms 10.using health foods, supplements, and medicines that affect test results 11.with current or past drug or alcohol dependence 12.are undergoing hospital visits due to mental disorders (depression, etc.), sleep disorders, etc., or have a history of mental disorders in the past 13.with irregular life rhythm due to night work or shift work 14.lifestyle habits may change during the period from the preliminary examination 15.with extremely irregular lifestyles such as eating and sleeping 16.have an extremely unbalanced diet 17.participated in other clinical trials (research) within 3 months prior to the date of consent acquisition, or those who plan to participate in other clinical trials (research) during the trial period 18.have collected or donated more than 200 mL of blood within 1 month or 400 mL of blood within 3 months prior to the date of obtaining informed consent 19.have difficulty keeping track of various questionnaires 20.judged to be unsuitable as subjects based on clinical test values and measured values at the time of SCR 21.are judged to be inappropriate as subjects by the principal investigator

Related Information

• Primary Sponsor: BHN Co., Ltd
• Source(s) of Monetary Support: Jinmon Co., Ltd