None listed
Conditions
Interventions
Daily intake of the test food for 12 weeks
Daily intake of placebo (control food) for 12 weeks
Sponsors
APO PLUS STATION CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Healthy Japanese males and females aged 20 or more and less than 60. 2)Those with a BMI of 23.0 kg/m^2 or more and less than 30.0 kg/m^2 at the time of screening. 3)Those with a visceral fat area of 80 cm^2 or more at the time of screening. 4)Those with a waist circumference of 85 cm or more for men and 90 cm or more for women at the time of screening. 5)Those with a body fat percentage of 25 % or more at the time of screening. 6)Those who fall under ratings A to C in the "Guidelines for assessing medical examination results and follow-up guidance for health checkups", 2024 edition published by the Japan Society of Ningen Dock. 7)Those who can visit the hospital on the designated visit dates. 8)Those who can take the test food once a day. 9)Those who can fill in lifestyle questionnaires every day during the test period. 10)Those who can complete a dietary survey for the set period. 11)Those who can finish eating and drinking by 9pm and refrain from taking alcohol the day before the tests. 12)Those who can comply with intake restrictions other than drinking an appropriate amount of water, until the end of the test on the day of the tests. 13)Those who can follow instructions from the hospital regarding CT scans. 14)Those who can submit the written informed consent form.
Exclusion criteria
Exclusion criteria: 1)Those who are on treatment or have a history of malignant tumors, heart failure, or myocardial infarction. 2)Those with a pacemaker or implantable cardioverter defibrillator. 3)Those who are currently undergoing treatment for the following chronic diseases: arrhythmia, liver disorder, kidney disorder, cerebrovascular disease, rheumatism, diabetes, dyslipidemia, hypertension, and other chronic diseases. 4)Those who regularly use medicines, quasi-drugs, supplements, and diet foods that affect body fat. 5)Those who cannot refrain from consuming health foods that affect body fat. 6)Those who cannot refrain from consuming foods/ drinks containing lactic acid bacteria other than the test foods (yogurt, lactic acid drinks such as Yakult, etc.). 7)Those who regularly drink an amount of alcohol exceeding the recommended amount. 8)Those who smoke an average of more than 20 cigarettes per day. 9)Those with extremely irregular lifestyles (those who work night shifts or shift rotations). 10)Those who have large changes in their diet and exercise habits and are unable to maintain their daily lifestyle. 11)Those who underwent a barium examination 2 weeks prior to the CT scan. 12)Those with metal or other materials embedded in the area to be CT scanned. 13)Those whose weight change in the past year is outside the range of 1 to 2 kg. 14)Those who regularly exercise. 15)Those who have had blood drawn or donated more than 200 mL of blood within a month or more than 400 mL within 3 months before the screening test. 16)Those who have a dairy allergy or who have hypersensitive reactions to the test foods. 17)Those who are pregnant, breastfeeding or planning to become pregnant during the study period. 18)Those who participated in other clinical trials within a month prior to the date of consent, or plan to participate in other clinical trials during the study period. 19)Those who are judged as ineligible for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body fat (total fat area) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Visceral fat area 2)Subcutaneous fat area 3)Body weight 4)BMI 5)Body fat weight 6)Body fat percentage 7)Fat free mass 8)Waist circumference 9)Hip circumference 10)Waist/hip ratio 11)Segmental muscle mass (limbs and trunk) 12)Triglycerides 13)Total cholesterol 14)HDL-cholesterol 15)LDL-cholesterol 16)Fasting blood glucose 17)Insulin 18)HbA1c 19)HOMA-IR 20)Comprehensive analysis of gut bacteria composition | — |
Countries
Japan
Contacts
Public ContactMisaki Sakata
APO PLUS STATION CO., LTD. Clinical Operations Dept., CRO Business div.
Outcome results
None listed