Effects of consumption of the test food on the intestinal environment in healthy Japanese subjects

Effects of consumption of the test food on the 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 intestinal environment in healthy Japanese subjects

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000049636

Enrollment

Registered

2022-11-28

Start date

2022-11-28

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: Three weeks Test food: Food containing galactooligosaccharide Administration: Take one packet with approximately 120 ml of water without vapour (room temperature or chilled) at any time du

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy subjects 5. Subjects whose numbers of Bifidobacterium genus is not zero (whose Bifidobacterium genus can be detected) at screening (before consumption; Scr) 6. Subjects whose numbers of Bifidobacterium genus is few at Scr

Exclusion criteria

Exclusion criteria: Subjects (who/whose) 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator 3. 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. use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. are currently taking medications (including herbal medicines) and supplements 6. are allergic to medicines and/or the test food related products (particularly, galactooligosaccharide) 7. are pregnant, lactating, or planning to become pregnant during this trial 8. suffer from COVID-19 9. have been enrolled in other clinical trials within the last 28 days before agreeing to participate or plan to participate another trial during this trial 10. are judged as ineligible in this study by the physician 11. have lactose intolerance 12. have a medical history of autoimmune disease or sea squirt asthma 13. usually take food/beverage containing functional ingredients that may influence the intestinal environment (e.g. dietary fiber, indigestible dextrin, isomaltodextrin, inulin, guar gum degradation products, fructooligosaccharides, galactooligosaccharides, lactulose, lactic acid bacteria, bifidobacteria, butyric acid bacteria, Bacillus subtilis var. natto, maltobionic acid, fucose, cocoa polyphenols, raffinose, kestose, polydextrose, lactosucrose, xylooligosaccharide, isomaltooligosaccharide, psyllium, resistant starch, galactomannan, or glucomannan) 14. usually take fermented foods (e.g. yogurt or natto), foods with rich dietary fiber (e.g. brown rice or green juice), or foods containing oligosaccharide (e.g. banana or honey)/who take them to improve the intestinal environment 15. food intake was extremely high/low right before Scr

Design outcomes

Primary

Measure	Time frame
1. The numbers of Bifidobacterium genus at three weeks after consumption	—

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