Healthy adults
Conditions
Interventions
Consumption of the test food three times a day for 12 weeks.
Consumption of the placebo food three times a day for 12 weeks.
Sponsors
Allm Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Healthy men more than 30 and below 59 years old at the time of obtaining consent to participate in the study. 2) Subjects who have given written consent (Consent to participate in MYCODE Research) to participate in MYCODE Research or who are registered members of Lsmile participant panel. 3) Subjects with a BMI equal to or greater than 25 but less than 30. 4) Subjects with a waist circumference of 85 cm or more. 5) Subjects who have received sufficient explanation regarding the purpose and content of this study, are capable of giving consent, volunteer for participation willingly with a thorough understanding, consent to participate in this study, and are able to come to the examination venue on the specified examination date to undergo the examination.
Exclusion criteria
Exclusion criteria: 1) Subjects with previous and/or current medical history of disease in digestive system or of serious disease in heart, lung, kidney, liver and blood etc.. 2) Using drugs related to obesity, dyslipidemia or glucose metabolism disorders, and those who have been diagnosed with familial diseases related to these disorders. 3) Suffering from autoimmune diseases. 4) Subjects with severe anemia. 5) Currently taking antibiotics or have taken antibiotics in the past 2 weeks. 6) Allergic to test food ingredients (soybeans) or to the ingredients of the meal distributed the day before blood collection. 7) Subjects with a history of drug or alcohol abuse. 8) Subjects with pacemakers or other medical electronic devices. 9) Subjects who have difficulty in undergoing CT scans due to claustrophobia, etc.. 10) Subjects who regularly use Functional Foods and Foods for Specified Health Uses related to the evaluation indices of this study (body fat, triglyceride, visceral fat, and metabolic rate). 11) Currently participating in another clinical trial (excluding non-interventional observational studies) or planning to participate in another clinical trial (excluding non-interventional observational studies) during this study. 12) Subjects who are judged to be unsuitable for this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visceral fat area (CT scan) | — |
Secondary
| Measure | Time frame |
|---|---|
| Resting energy expenditure Fecal amount of Bifidobacterium Concentrations of acetic acid in feces and blood | — |
Countries
Japan
Contacts
Public ContactTatsuya Matsuda
Allm Inc. Medical and Pharma DX Department
Outcome results
None listed