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The effects of test meal intake on the intestinal environment

The effects of test meal intake on the intestinal environment - The effects of test meal intake on the intestinal environment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000055811
Enrollment
30
Registered
2024-10-12
Start date
2024-10-13
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

Intake test meal three times a day before each meal, every day for four weeks

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 2.Persons who are Japanese and 20 years old or more and under 60 years old 3.Persons who tend to be constipated (defecation frequency: 2-5 times per week, with subjective symptoms of constipation)

Exclusion criteria

Exclusion criteria: 1.Persons who have chronic illness, receiving medication, have a serious disease history 2.Persons who have a history of gastrointestinal surgery (excluding appendectomy or endoscopic polyp removal) 3.Persons who have or have a history of intestinal obstruction, esophageal stenosis, or abnormal intestinal narrowing 4.Persons who are allergic to the test food 5.Persons who are taking supplements containing dietary fiber 6.Persons who regularly take medicine (including laxatives), Chinese medicine, foods with health claims (foods for specified health uses, foods with functional claims, and foods with nutritional claims) that may affect the intestinal environment 7.Persons whose daily water intake is extremely low 8.Persons who have a habit of skipping meals 9.Persons who cannot prepare and consume the test food three times a day before each meal as instructed 10.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 11.Persons who were judged as inappropriate for study participants by the principal investigator 12.Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding

Design outcomes

Primary

MeasureTime frame
Defecation frequency per week and intestinal microbiota analysis

Secondary

MeasureTime frame
Questionnaire (defecation, dietary records, physical condition), Fecal moisture content, Fecal pH, Fecal putrefactive substances, Fecal short-chain fatty acids, Urinary indoxyl sulfate levels corrected for creatinine Body weight, BMI, Waist circumference

Countries

Japan

Contacts

Public ContactKazuma Toda

Healthcare Systems Co., Ltd. Clinical Research Department

toda.kazuma@hc-sys.jp0368092722

Outcome results

None listed

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