None listed
Conditions
Interventions
Daily intake of a food containing bifidobacterium for 4 weeks.
Daily intake of placebo for 4 weeks.
Sponsors
APO PLUS STATION CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Healthy Japanese males and females aged 20 to 64 years,at the time of informed consent. 2)Participant with 3 to 5 bowel movements per week during the 2-week pre-observation period. 3)Participant who can visit the trial site on the scheduled visit date. 4)Participant who fully understand the purpose and content of this study and provided written consent prior to trial initiation.
Exclusion criteria
Exclusion criteria: 1)Participant taking medicines/foods that affect the intestinal environment three or more times per week. 2)Participant with a history of serious liver, kidney, cardiovascular, gastrointestinal, pulmonary, blood, or metabolic disease. 3)Participant with chronic diseases and regular users of medicines. 4)Participant with a history or current history of drug or alcohol dependence. 5)Participant with a history of gastrointestinal disease or surgery that affects digestion, absorption, or defecation. 6)Participant with food allergies related to the test food. 7)Participant with extremely irregular daily habits and eating habits (including late-night workers). 8)Participant who cannot restrict the use of drugs/foods that affect the study after obtaining consent. 9)Participant with excessive exercise, alcohol consumption, or smoking habits. 10)Pregnant or lactating women or women who may become pregnant during the study period. 11)Participant who have taken antibiotics within 1 month prior to obtaining consent, or plan to take them during the study period. 12)Participant who have participated in any other clinical research within 1 month prior to obtaining consent, are currently participating, or are scheduled to participate during the study period. 13)Participant who plan to change their lifestyle drastically after obtaining consent and before the end of the study. 14)Participant who plan to travel abroad after obtaining consent and before the end of the study. 15)Participant judged to be unsuitable based on their answers to the background questionnaire. 16)Other participant who are judged by the investigator to be unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Organic acids content in feces.(Acetic acid) 2)Organic acids content in feces.(Propionic acid) 3)Organic acids content in feces.(n-butyric acid) | — |
Secondary
| Measure | Time frame |
|---|---|
| Fecal analysis (Counts of Bifidobacterium, Amplicon sequencing analysis, Organic acids, Putrefactive products, Ammonia, pH, water content), Defecation survey, NOx (nitric oxide), RLP-C, baPWV, adiponectin, Visual Analog Scale. | — |
Countries
Japan
Contacts
Public ContactMisaki Sakata
APO PLUS STATION CO., LTD. Clinical Operations Dept., CRO Business div.
Outcome results
None listed