Study on the effect of fermented botanical product in middle-aged and elderly people

Study on the effect of feeding fermented plant products (FBP) in middle-aged and elderly people in an unwell state - Research on the effects of FBPin middle-aged and elderly people

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031250683

Enrollment

Registered

2026-01-27

Start date

2026-03-06

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

None listed

Interventions

FBP 5.0 g will be consumed once daily after breakfast for one month.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Middle-aged and elderly residing in or attending a health care facility for the elderly (2) Persons who are between 50 and 100 years of age at the time consent is obtained. (3) Persons who have given their written consent to participate in this study.

Exclusion criteria

Exclusion criteria: (1) Individuals with physical or cognitive impairments who have difficulty ingesting FBP (2) Individuals who have been newly administered or had the dosage changed for medications that could affect research results within six months of obtaining consent (Specifically: antidepressants, antipsychotics, sleeping pills, laxatives, antibiotics, anxiolytics, mood stabilizers, antiepileptics, anti-dementia drugs) (3) Individuals with allergies to FBP or its components (4) Individuals deemed ineligible by the judgment of the principal (or sub-principal) investigator.

Design outcomes

Primary

Measure	Time frame
Chronic fatigue assessment using the Japanese version of Chalder's fatigue scale	—

Secondary

Measure	Time frame
(1) Depression evaluation by CES-D Japanese version (2) Physical condition evaluation by VAS (3) Constipation evaluation using the Japanese version of the Constipation Assessment Scale (CAS-MT) (4) Sleep quality assessment by VAS (5) apple watch measurement items	—

Contacts

Public ContactKeiji Hashimoto

SHOWA Medical University Fujigoka Rehabilitation Hospital

keiman@med.showa-u.ac.jp+81-45-974-2221

Outcome results