A verification study of the improving effect of bowel movement by the test food consumption

A verification study of the improving effect of bowel movement by the test food consumption in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study - A verification study of the improving effect of bowel movement by the test food consumption in healthy Japanese subjects

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000047850

Enrollment

Registered

2022-05-25

Start date

2022-05-26

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 Japanese subjects

Interventions

Duration: Two weeks Test food: Active food Duration: Two weeks Test food: Placebo food

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy subjects 5. Subjects whose defecation frequency is three to five times per week 6. Subjects who always have carbohydrates (such as rice, bread, and noodles) in every meal

Exclusion criteria

Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects who currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. Subjects who currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, lactation, or planning to become pregnant 8. Subjects who suffer from COVID-19 9. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 10. Subjects who are judged as ineligible to participate in the study by the physician

Design outcomes

Primary

Measure	Time frame
1. Defecation frequency at the 2nd week after consumption of the test food	—

Secondary

Measure	Time frame
1. Defecation frequency at the 1st week after consumption of the test food 2. Numbers of defecation days and amount of defecation at the 1st and 2nd week after consumption of the test food 3. Stool shape, stool smell, and exhilarating feeling of defecation at the 1st and 2nd week after consumption of the test food 4. The score of The Japanese Version of the Constipation Assessment Scale (CAS) 5. Each item of CAS 6. Bifidobacterium, Lactobacillales order, Bacteroides, Prevotella, Clostridium cluster IV, Clostridium cluster IX, Clostridium cluster XI, Clostridium subcluster XIVa, Clostridium cluster XVIII	—

Measure

Time frame

1. Defecation frequency at the 1st week after consumption of the test food 2. Numbers of defecation days and amount of defecation at the 1st and 2nd week after consumption of the test food 3. Stool shape, stool smell, and exhilarating feeling of defecation at the 1st and 2nd week after consumption of the test food 4. The score of The Japanese Version of the Constipation Assessment Scale (CAS) 5. Each item of CAS 6. Bifidobacterium, Lactobacillales order, Bacteroides, Prevotella, Clostridium cluster IV, Clostridium cluster IX, Clostridium cluster XI, Clostridium subcluster XIVa, Clostridium cluster XVIII

—

Countries

Japan

Contacts

Public ContactNaoko Suzuki

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

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