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Functional exploratory trial of symbiotic connection between food microorganism and oligosaccharide

Functional exploratory trial of symbiotic connection between food microorganism and oligosaccharide - Functional exploratory trial of symbiotic connection between food microorganism and oligosaccharide

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000043275
Enrollment
80
Registered
2021-03-31
Start date
2021-03-31
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 male/female adults

Interventions

Oral ingestion of pro/prebiotics for 12 weeks. Oral ingestion of probiotics for 12 weeks. Oral ingestion of prebiotics for 12 weeks. Oral ingestion of placebo for 12 weeks.

Sponsors

CPCC Company Limited
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Male/female subjects ranging in age from 20 to 64 at informed consent. 2) Subjects ranging in BMI from 25.0 to <30.0 kg/m2. 3) Subjects who can give informed consent to participate in this trial after being provided with an explanation of the experimental protocol detail.

Exclusion criteria

Exclusion criteria: 1) Subjects with previous/present medical history of serious diseases. 2) Subjects who contracted a digestive disease within the past two weeks, and are now under medical treatments. 3) Subjects with medical therapies for a lifestyle-related disease, such as diabetes, hypertension and dyslipidemia. 4) Subjects with milk allergy or suspicious one. 5) Pregnant, possibly pregnant during this trial, or lactating women. 6) Subjects falling into the habit of heavy smoking, excessive alcohol intake, and/or an irregular life rhythm. 7) Subjects taking steadily (not less than three times a week) in the health foods, probiotics, prebiotics, fermented milk and/or lactic acid beverages, which might affect the test results. 8) Subjects who took part in the other clinical/monitoring tests, except observing ones, within a month before giving informed consent to take part in this trial. 9) Others who have been determined as ineligible for participation in this trial, judging from the principal/sub investigator's opinions.

Design outcomes

Primary

MeasureTime frame
1. Visceral fat area 2. Body fat percentage 3. Body fat mass 4. Body weight 5. Body mass index 6. Gut microbiota 7. Short chain fatty acids in blood and feces (acetic/propionic/n-butyric/iso-butyric/n-valeric/iso-valeric acids) 8. Gastrointestinal hormones (PYY, GLP-1, GIP, insulin) 9. Blood-biochemical test (Total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, blood glucose, and HbA1c)

Countries

Japan

Contacts

Public ContactMakoto Ichinohe

CPCC Company Limited Clinical Planning Department

cpcc-contact@cpcc.co.jp03-5297-3112

Outcome results

None listed

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