Healthy subjects
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Men and women aged 25 or more and 60 or less 2) Subjects whose BMI are 25 kg/m2 or more and less than 30 kg/m2 at screening 3) Fully informed of the purpose and content of the study, deemed to have the capacity to consent, and volunteered of their own accord to participate in the study based on a thorough understanding of the purpose and content of the study, and provided written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1)Subjects who are undergoing medical treatment of chronic diseases 2)Treatment for severe kidney disease, heart disease, respiratory disease, endocrine disease, thyroid disease, adrenal gland disease, other metabolic diseases, diabetes, or other illness (excluding transient illnesses such as colds) 3)use of antibiotics within 1 month prior to the start of the study 4)regularly use intestinal drugs and laxatives (including strong laxatives) 5)unable to stop intake of health foods or supplements that affect energy metabolism 6)unable to restrict the intake of foods that might affect the intestinal microbiota 7)Who regularly consume yogurt, lactic fermenting beverages, and foods with intestinal function (those who can discontinue consumption from the screening test to the end of the study are allowed), and those who cannot stop consuming probiotics, fermented foods, and foods containing high amounts of oligosaccharides. 8)who cannot abstain from alcohol for 2 days prior to each test. 9)who are unable to fast for 12 hours prior to the metabolic rate measurement or are unable to consume 3 meals of the prescribed foods. 10)who cannot have a stool sample taken during the specified period or cannot arrange for shipping. 11)Smokers 12)history of allergy to any of the study food ingredients 13)current or former drug or alcohol dependence 14)Shift workers or late-night workers 15)who exercise regularly (about 60 minutes per week of breathless and sweaty exercise) 16)who have a cardiac pacemaker, implantable cardioverter-defibrillator, or who have metal in the measurement site due to surgery, etc. 17)who are pregnant, lactating, or planning to become pregnant during this trial 18)who are participating, or intend to participate during the study period, in a study involving the ingestion of other foods or the use of drugs, or the application of cosmetics or drugs. 19)deemed ineligible by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resting energy expenditure at four weeks after consumption (4w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Resting energy expenditure at two weeks after consumption (2w) 2. Respiratory quotient, energy expenditure, muscle mass, skeletal muscle mass, body fat percentage, body fat mass, acetic acid, propionic acid, isobutyric acid, n-butyric acid, isovaleric acid, n-valeric acid, lactic acid, succinic acid, formic acid, and fecal Bifidobacterium at 2w and 4w | — |
Countries
Japan
Contacts
KSO Corporation Clinical Trial Management department