Effects of consumption of the test food on the bowel movement in healthy Japanese subjects

Effects of consumption of the test food on the bowel movement in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study - Effects of consumption of the test food on the bowel movement in healthy Japanese subjects

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000048594

Enrollment

Registered

2022-08-04

Start date

2022-08-04

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: Four weeks Test food: Ginger capsule Administration: Take one capsule in the morning *If you forget to take the test food, take it as soon as you remember. Daily dose should be taken w

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

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 currently undergoing treatment for any of the following chronic diseases: 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 are 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 during this trial 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 this study by the physician

Design outcomes

Primary

Measure	Time frame
1. The defecation frequency in period VI* *Period VI: The 4th week after consumption of the test food	—

Secondary

Measure	Time frame
1. The defecation frequency in period III, IV, and V* 2. The numbers of defecation days and amount of defecation in period III, IV, V, and VI* 3. The rate of each state for stool shape, stool smell, and exhilarating feeling of defecation in period III, IV, V, and VI* 4. The score and each item of The Japanese Version of the Constipation Assessment Scale (CAS) 5. Gastrointestinal symptom rating scale (GSRS), MOS Short-Form 36-Item Health. Survey (SF-36), and water content in stool *Period I-II: Before consumption of the test food Period III: The 1st week after consumption of the test food Period IV: The 2nd week after consumption of the test food Period V: The 3rd week after consumption of the test food Period VI: The 4th week after consumption of the test food	—

Measure

Time frame

1. The defecation frequency in period III, IV, and V* 2. The numbers of defecation days and amount of defecation in period III, IV, V, and VI* 3. The rate of each state for stool shape, stool smell, and exhilarating feeling of defecation in period III, IV, V, and VI* 4. The score and each item of The Japanese Version of the Constipation Assessment Scale (CAS) 5. Gastrointestinal symptom rating scale (GSRS), MOS Short-Form 36-Item Health. Survey (SF-36), and water content in stool *Period I-II: Before consumption of the test food Period III: The 1st week after consumption of the test food Period IV: The 2nd week after consumption of the test food Period V: The 3rd week after consumption of the test food Period VI: The 4th week after consumption of the test food

—

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