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

Not Applicable
Conditions
Healthy subjects
Registration Number
JPRN-UMIN000044019
Lead Sponsor
HUMA R&D CORP
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
60
Inclusion Criteria

Not provided

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)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Stool test(Intestinal flora, short chain fatty acids, metabolome analysis)
Secondary Outcome Measures
NameTimeMethod
(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
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