Healthy adults
Conditions
Interventions
Oral ingestion of oligosaccharide for 4 weeks
Oral ingestion of placebo for 4 weeks
Sponsors
Meiji Holdings Co., Ltd.
Meiji Co., Ltd. Chiyoda Paramedical Care Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy adults aged 20-64 years at the time of consent 2. Persons who, after adequate explanation of the study purpose and procedures, have the capacity to consent, understand the information, and voluntarily provide informed consent to participate
Exclusion criteria
Exclusion criteria: 1. History of gastric or lower gastrointestinal surgery (excluding hemorrhoid surgery and polypectomy) 2. Current serious disease affecting the liver, kidneys, heart, lungs, or gastrointestinal tract, or other organ dysfunction; diabetes mellitus; rheumatoid arthritis; neurological or psychiatric disorders; sleep disorders; chronic fatigue syndrome; or any other serious or progressive disease 3. Underwent gastric X-ray barium examination or bowel cleansing (in a clinic or at home) within 1 month prior to screening, or plans to undergo these during the study 4. Took any antibiotic at least once within 1 month prior to screening, or is taking at least weekly-or plans to take during the study-any medication that may affect the study (e.g., proton-pump inhibitors, antidiabetic drugs such as metformin, laxatives such as magnesium oxide, or ursodeoxycholic acid) 5. Current smoker within 1 month prior to consent 6. Plans for overseas travel, or trips/business travel longer than 1 week, from the date of consent until completion of the 4-week post-consent assessment 7. Average daily alcohol consumption exceeds sixty grams of ethanol 8. Irregular lifestyle due to shift or night work 9. Performing resistance training more than 4 times per week (e.g., weight training with barbells, dumbbells, or machines) 10. Presence of food allergies 11. Pregnant, lactating, or possibly pregnant 12. Any other condition judged by the principal or sub-investigator to be inappropriate for study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gut microbiota, Intestinal barrier function, Systemic inflammation, Muscle proteolysis, Frailty indicators, Bowel habits, Gastrointestinal symptoms, Quality of life, Sleep, Fatigue, Vitality, Mental health | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Clinical Planning Department
Outcome results
None listed