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Placebo-controlled, double-blind, randomized, parallel-group comparative study of the effect of ingestion of test food on improving the intestinal environment

Placebo-controlled, double-blind, randomized, parallel-group comparative study of the effect of ingestion of test food on improving the intestinal environment - Study of the effect of ingestion of test food on improving the intestinal environment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000045324
Enrollment
60
Registered
2021-08-31
Start date
2021-09-29
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adults

Interventions

Ingest test food A by dissolving it in water or lukewarm water at breakfast every day for 8 weeks. Ingest test food B by dissolving it in water or lukewarm water at breakfast every day for 8 weeks. In

Sponsors

Healthcare Systems Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document 2. Japanese who are 30 years old or more and under 50 years old 3. Those who are aware of constipation tendency (defecate 2 to 5 times / week) 4. Select 60 people with high average similarity regarding the intestinal flora at the time of screening.

Exclusion criteria

Exclusion criteria: 1. Persons who have chronic illness, receiving medication, have a serious disease history 2. Persons who have less than 1 bowel movement / week 3. Persons who are allergic to the test food 4. Persons who usually take a large amount of supplements containing dietary fiber and oligosaccharides 5. Persons who regularly use medicines, foods for specified health use, health foods, etc. that may affect the intestinal environment 6. Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam 7. Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding 8. Persons who were judged as inappropriate for study participants by the principal investigator

Design outcomes

Primary

MeasureTime frame
Number of bowel movements / week Gut microbiota analysis before, 4 weeks after, and 8 weeks after ingestion.

Secondary

MeasureTime frame
Questionnaire on defecation status Gut microbiota analysis Stool water content Stool pH Fecal putrefactive substances Short-chain fatty acids in feces Skin moisture content Weight, BMI, abdominal circumference Questionnaire on sleep, stress and fatigue before, 4 weeks after, and 8 weeks after ingestion.

Countries

Japan

Contacts

Public ContactTakamasa Masuda

Healthcare Systems Co., Ltd. Research and Development Department

masudat@hc-sys.jp03-6809-2722

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026