Verification test of body fat-reducing effect of lactic acid bacterium containing foods

UMIN ID: UMIN000032404

Registered date:21/05/2018

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy adult
• Date of first enrollment: 2018/05/21
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Ingestion of test food containing a lactic acid bacterium for 12 consecutive weeks
Ingestion of placebo without a lactic acid bacterium for 12 consecutive weeks

Outcome(s)

• Primary Outcome: Visceral fat area, body composition (body weight, body mass index, body fat percentage), and abdominal circumference
• Secondary Outcome: Hematologic test, blood biochemical test, vital signs

Key inclusion & exclusion criteria

• Age minimum: 30years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1)People who regularly drink or drink yogurt containing lactobacilli *Yogurt consumption will not be excluded if habit exists during the study 2)Persons who are unable to limit the use of drugs, health foods, foods for specified health use, functional labeling foods, health supplements, supplements, etc., which may affect body fat, as well as foods high in lactobacilli and oligosaccharides after obtaining informed consent 3)Subjects who were receiving medication at the time of study entry and were attending the clinic for body fat-related disease 4)Persons with or with a history of diseases such as diabetes, liver disease, kidney disease, or heart disease 5)Persons who have been diagnosed with familial hyperlipidemia 6)Persons currently undergoing exercise and diet therapy under the supervision of a physician 7)Persons who regularly engage in strenuous exercise 8)Persons with diseases requiring constant medication 9)Persons with a history of serious disease requiring medical treatment 10)Persons with a history of drug or food allergy 11)Patients who have metal in the CT scan measurement site due to surgery, etc. 12)Patients with cardiac pacemakers or implantable cardioverter defibrillators. 13)People with claustrophobia 14)Subjects who are judged inappropriate as subjects based on the responses to the background questionnaire 15)Subjects with significant deviations from reference ranges in pre-test physical, physical, and laboratory measurements 16)Pregnant, lactating women, or women who wish to become pregnant during the study 17)Persons with a current or past history of psychiatric disorders 18)Persons who work shift,such as night shift workers 19)Patients who are receiving or have a history of drug dependence or drug abuse. 20)Individuals who have participated in other human clinical studies or are currently participating in other human clinical studies within the past 3months 21)Other subjects who are considered inappropriate as subjects 22)Meetings are required

Related Information

• Primary Sponsor: HUMA R&D CORP
• Source(s) of Monetary Support: Pickles corporation