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 and intestinal environment 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 and intestinal environment in healthy Japanese subjects

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000047878

Enrollment

Registered

2022-05-27

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: Capsule containing 10-hydroxy-cis-12-octadecenoic acid (HYA) Administration: Take three capsules (HYA 300 mg) with water three times a day before each meal. *Daily

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 whose defecation frequency is relatively few in seven days prior to Scr

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 inappropriate as subjects from answers to lifestyle questionnaires 11. Subjects who are judged as ineligible to participate in the study by the physician

Design outcomes

Primary

Measure	Time frame
1. The measure measured values of defecation frequency in period IV* *Period IV: The 2nd week after consumption of the test food	—

Secondary

Measure	Time frame
1. The amount of change of defecation frequency between period I to period IV* 2. The measured values and amount of change from period I of defecation frequency in period II and III* 3. The measured values and amount of change from period I of numbers of defecation days and amount of defecation in period II, III, and IV* 4. The rate of each state for stool shape, stool smell, and exhilarating feeling of defecation in period II, III, and IV* 5. The measured values and amount of change from screening (before consumption; Scr) of the score of The Japanese Version of the Constipation Assessment Scale (CAS) at two weeks after consumption (2w) 6. The measured values of each item of CAS at 2w 7. The measured values of the diversity index and the occupancy rate of bacteria in the stool at 2w 8. The amount of change of the diversity index and the occupancy rate of bacteria in the stool between Scr and 2w *Period I: Seven days prior to Scr Period II: Seven days prior to the first 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	—

Measure

Time frame

1. The amount of change of defecation frequency between period I to period IV* 2. The measured values and amount of change from period I of defecation frequency in period II and III* 3. The measured values and amount of change from period I of numbers of defecation days and amount of defecation in period II, III, and IV* 4. The rate of each state for stool shape, stool smell, and exhilarating feeling of defecation in period II, III, and IV* 5. The measured values and amount of change from screening (before consumption; Scr) of the score of The Japanese Version of the Constipation Assessment Scale (CAS) at two weeks after consumption (2w) 6. The measured values of each item of CAS at 2w 7. The measured values of the diversity index and the occupancy rate of bacteria in the stool at 2w 8. The amount of change of the diversity index and the occupancy rate of bacteria in the stool between Scr and 2w *Period I: Seven days prior to Scr Period II: Seven days prior to the first 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

—

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