healthy adults
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female employees of Ezaki Glico Co., Ltd., aged 20 to 64 years 2.Subjects who have a body mass index (BMI) of 23.0 kg/m2 or higher 3.Subjects who have received sufficient explanation of the purpose and content of the study, have the capacity to consent, have voluntarily volunteered to participate based on a good understanding of the study, and have agreed to participate in the study in writing
Exclusion criteria
Exclusion criteria: 1. Subjects who have used antibiotics within 2 weeks prior to the start of the study. 2. Subjects who are judged to have difficulty providing written informed consent for the study. 3. Subjects who are pregnant, planning to become pregnant during the study period, or are breastfeeding. 4. Subjects who have excessive alcohol consumption (an average daily intake of 60 g or more of pure alcohol). 5. Subjects who have a known allergy to the investigational food. 6. Subjects who are currently participating in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in body fat mass over 8 weeks (measured by Inbody) | — |
Secondary
| Measure | Time frame |
|---|---|
| Body composition (measured by Inbody) at weeks 0, 4, and 8; gut microbiota (relative abundance, diversity, etc.) at weeks 0 and 8; fecal short-chain fatty acid (SCFA) levels at weeks 0 and 8; bowel movement frequency, consistency, and volume; bristol stool scale; body composition (measured with a consumer body composition monitor) from weeks 0 to 8 | — |
Countries
Japan
Contacts
Ezaki Glico Co., Ltd. Dairy Business Division