Verification test of body fat reduction effect by ingesting test food

UMIN ID: UMIN000047267

Registered date:19/06/2022

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: healthy participants
• Date of first enrollment: 2022/03/07
• Target sample size: 75
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Ingest foods containing 100 mg of plant-derived extract for 12 weeks
Ingest foods containing 300 mg of plant-derived extract for 12 weeks
Inoculate placebo food for 12 weeks

Outcome(s)

• Primary Outcome: Body fat 8 weeks,12 weeks after the start of food intake
• Secondary Outcome: 8, 12 weeks after the start of feeding Belly fat Body weight BMI Waist circumference

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 64years-old
• Gender: Male and Female
• Exclude criteria: (1) Those who are currently judged to have dyslipidemia or hypertension and are undergoing some kind of treatment. (2) Ingesting foods and health foods containing the ingredients involved in this test food (plant extract)person (3) Health foods and dietary supplements related to cholesterol, blood pressure, blood lipids, and blood sugar levelsThose who use it regularly (4) Glucose metabolism, lipid metabolism, liver disease, renal disease, cardiovascular disease, digestive disease, respiratory disease, blood Persons with serious diseases such as humoral diseases, autoimmune diseases, endocrine diseases, and metabolic diseases.Or a person who has a medical history (5) Persons with a history of drug allergies or serious food allergies (6) Persons who have had abnormal laboratory test values and were judged to have problems participating in the study (7) Persons with illnesses who are currently undergoing hospital visits, treatment, use of medications / external medicines, and follow-up (8) Those who were judged to be inappropriate as subjects based on the results of the subject background questionnaire. (9) Those who participated in other clinical studies at the start of this study (10) Those who are pregnant or plan to breastfeed during the study period (11) Persons who are judged by the investigator (or the person in charge of conducting the examination) to be inappropriate for participating in the examination

Related Information

• Primary Sponsor: Medicial Corporation Kenshokai, Fukushima Healthcare Center
• Source(s) of Monetary Support: Iwase Cosfa Co., Ltd.