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Verification of the effect of test food intake on the intestinal environment for the elderly

Verification of the effect of test food intake on the intestinal environment for the elderly - Verification of the effect of test food intake on the intestinal environment for the elderly

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000044019
Enrollment
60
Registered
2022-07-20
Start date
2021-04-26
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 subjects

Interventions

Sponsors

HUMA R&D CORP
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Japanese men and women aged 70 and over at the time of obtaining written consent. 2.Subject with BMI>=18.5 and <25. 3.Subject who has received sufficient explanation of the purpose and content of the research, have the ability to consent, voluntarily volunteered to participate in the examination after understanding it well, and agreed to participate in the examination in writing.

Exclusion criteria

Exclusion criteria: 1.Subject who is taking medication or under medical treatment.However, if it falls under any of the following diseases, it can be incorporated as necessary.Eye disease, hypertension, dyslipidemia, hyperuricemia, osteoporosis 2.Subject who is under exercise therapy or dietetic therapy. 3.Subject who may develop allergies due to test foods. 4.Subject with current or history of drug or alcohol dependence. 5.Subject who is out of the hospital due to mental disorders (depression, etc.) or sleep disorders, or who have a history of mental illness in the past 6.Subject with irregular life rhythms due to night shifts or shift work 7.Subject who has extremely irregular lifestyle habits such as eating and sleeping 8.Subject who has an extremely unbalanced diet. 9.Serious diseases such as brain disease, malignant tumor, immune disease, diabetes, liver disease (hepatitis), renal disease, heart disease, thyroid disease, adrenal disease, and other serious current or past diseases such as metabolic disease those who have. 10.Subject who uses health foods, supplements, and medicines (intestinal regulators, antibiotics, laxatives, etc.) that affect the study. (Continue to other related information)

Design outcomes

Primary

MeasureTime frame
Stool test(Intestinal flora, short chain fatty acids, metabolome analysis)

Secondary

MeasureTime frame
(Secondary outcomes) Defecation survey,SF-8 Japanese version,The Philadelphia Geriatric Center Morale Scale (Safety evaluation) Vital signs, physical measurement, blood biochemistry, hematology, urinalysis, adverse events

Countries

Japan

Contacts

Public ContactDaisuke Ochitani

HUMA R&D CORP Public Relations Department

ochitani@huma-rd.co.jp03-3431-1260

Outcome results

None listed

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