Male/female adults
Conditions
Interventions
Oral administration of the test food (1 sachet, twice daily) for 16 weeks
Oral administration of the placebo food (1 sachet, twice daily) for 16 weeks
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female aged 20 to below 60 years at the time of consent acquisition. 2. Individuals with a BMI between 23.0 and less than 30.0 kg/m2 at the time of pre-examination. 3. Individuals who are able to give informed consent to participate in this study after receiving a detailed explanation of the protocol and understanding its contents.
Exclusion criteria
Exclusion criteria: 1. Individuals regularly using Food for Specified Health Uses (FOSHU), Foods with Function Claims, or health supplements (including supplements) more than three times a week that claim to reduce visceral fat or body fat, and cannot discontinue their use from the time of consent. 2. Individuals unable to discontinue intake of FOSHU, Foods with Function Claims, or health supplements (including supplements) that claim to reduce visceral fat or body fat from the time of consent (those who intake these less than twice a week and can discontinue may participate). 3. Individuals engaged in dietary restrictions or diets aimed at weight loss (defined as weight loss through exercise or by reducing food intake). 4. Individuals with scars or marks at the skin measurement sites. 5. Individuals with long nails or who wear three-dimensional nail art. 6. Individuals with non-removable metal objects (such as bolts or metal plates) in the CT imaging area. 7. Individuals who are participating in, have participated in within the four weeks prior to the current trial, or are planning to participate in clinical trials of pharmaceuticals or health foods. 8. Individuals with extremely irregular life or eating habits, such as shift workers or night workers. 9. Individuals with excessive alcohol intake. 10. Individuals with previous and/or current medical history of serious diseases in the heart, liver, kidney, digestive organs. 11. Females who are pregnant or lactating, and those who intend to become pregnant during the trial period. 12. Individuals with allergies to medications and/or food. 13. Individuals who donated 200 mL of their blood or blood components within the last month. 14. Individuals who donated 400 mL of his blood within the last 3 months. 15. Individuals who donated 400 mL of her blood within the last 4 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visceral fat area measured by X-ray computed tomography (CT). | — |
Secondary
| Measure | Time frame |
|---|---|
| Waist circumference, Body fat percentage, Total cholesterol (T-cho), Glucose (GLU), Hemoglobin A1c (HbA1c), Adiponectin levels, Total abdominal fat area (X-ray CT), Subcutaneous abdominal fat area (X-ray CT), Stratum corneum moisture content, Skin viscoelasticity, Transepidermal water loss, Advanced glycation end-products (AGEs), Pittsburgh Sleep Quality Index (PSQI) | — |
Countries
Japan
Contacts
Public ContactMasanori Numa
CPCC Company Limited Clinical Planning Department
Outcome results
None listed