None listed
Conditions
Interventions
Sponsors
APO PLUS STATION CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Japanese males and females aged between 20 and 64 years,inclusive,at the time of informed consent. 2) participants with high-normal BMI (>=23 and <25) or class I obesity (>=25 and <30), measured in kg/m^2. 3) participants who are aware of their tendency to overeat but have been assessed as healthy by a physician. 4) participants who have received a full explanation of the purpose and procedures of the study and have signed the informed consent form prior to study initiation.
Exclusion criteria
Exclusion criteria: 1) Participants who consume health foods, FOSHU, or functional foods containing lactobacilli or bifidobacteria at least once a week 2) Participants who regularly consume, at least weekly, products (medicines, health foods, FOSHU, or functional foods) with ingredients affecting glucose metabolism or appetite 3) Participants who engage in excessive regular physical exercise 4) Participants who skip meals at least once a week 5) Participants who habitually consume over 20g of pure alcohol daily 6) Participants who consume lactobacillus-rich foods (e.g., fermented milk drinks, yogurt, kimchi) or supplements at least twice a week 7) Participants diagnosed with binge eating disorder based on the BITE 8) Participants with serious conditions (e.g., diabetes, liver, kidney, or heart disease) or relevant medical history 9) Participants currently under treatment or with a history of serious illness requiring pharmacological intervention 10) Participants at risk of allergic reactions to the study intervention 11) Participants who donated 200/400 mL of blood or received a transfusion within 3 months before screening 12) Participants deemed unsuitable based on screening lab results or physical measurements 13) Participants who joined another clinical trial within 1 month before consent or plan to during the study 14) Participants diagnosed with chronic constipation 15) Participants who are pregnant, breastfeeding, or planning to during the study 16) Participants who are otherwise deemed unsuitable for participation in the study by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visceral fat area | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Total fat area 2) Subcutaneous fat area 3) Body weight 4) BMI 5) Body fat mass 6) Body fat percentage 7) Waist circumference 8) Hip circumference 9) Triglycerides 10) Total cholesterol 11) LDL-cholesterol 12) HDL-cholesterol 13) SNAQ-JE 14) GLP-1 15) Insulin 16) Glucose 17) HOMA-IR 18) Satiety VAS 19) BITE(Binge Eating Illness Self Evaluation Scale) 20) Relative abundance of gut microbiota at the phylum and family levels | — |
Countries
Japan
Contacts
Public ContactMisaki Sakata
APO PLUS STATION CO., LTD. Clinical Operations Dept., CRO Business div.
Outcome results
None listed