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A study on the health effects of Bifidobacterium and inulin intake in an uncontrolled environment

A study on the health effects of Bifidobacterium and inulin intake in an uncontrolled environment - A study on the health effects of Bifidobacterium and inulin intake in an uncontrolled environment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000059802
Enrollment
100
Registered
2025-11-17
Start date
2025-11-18
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 adults

Interventions

1. 8-week continuous intake of a food containing bifidobacterium and inulin 2. Regular body composition measurements

Sponsors

Ezaki Glico Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Male and female employees of Ezaki Glico Co., Ltd., aged 20 to 64 years 2.Subjects who have a body mass index (BMI) of 23.0 kg/m2 or higher 3.Subjects who have received sufficient explanation of the purpose and content of the study, have the capacity to consent, have voluntarily volunteered to participate based on a good understanding of the study, and have agreed to participate in the study in writing

Exclusion criteria

Exclusion criteria: 1. Subjects who have used antibiotics within 2 weeks prior to the start of the study. 2. Subjects who are judged to have difficulty providing written informed consent for the study. 3. Subjects who are pregnant, planning to become pregnant during the study period, or are breastfeeding. 4. Subjects who have excessive alcohol consumption (an average daily intake of 60 g or more of pure alcohol). 5. Subjects who have a known allergy to the investigational food. 6. Subjects who are currently participating in another clinical trial.

Design outcomes

Primary

MeasureTime frame
Changes in body fat mass over 8 weeks (measured by Inbody)

Secondary

MeasureTime frame
Body composition (measured by Inbody) at weeks 0, 4, and 8; gut microbiota (relative abundance, diversity, etc.) at weeks 0 and 8; fecal short-chain fatty acid (SCFA) levels at weeks 0 and 8; bowel movement frequency, consistency, and volume; bristol stool scale; body composition (measured with a consumer body composition monitor) from weeks 0 to 8

Countries

Japan

Contacts

Public ContactYuhei Baba

Ezaki Glico Co., Ltd. Dairy Business Division

yuhei.baba@glico.com080-9596-0792

Outcome results

None listed

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