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A Study on the Effect of Test food on Subjective symptoms in Aging Men -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-

A Study on the Effect of Test food on Subjective symptoms in Aging Men -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study- - A Study on the Effect of Test food on Subjective symptoms in Aging Men

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000047751
Enrollment
60
Registered
2022-05-13
Start date
2022-05-14
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

Active food A, 8 weeks consumption Active food B, 8 weeks consumption Placebo food, 8 weeks consumption

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Healthy males aged 35 to 64 years-old. 2) Subjects who are aware of feelings of decreased libido, etc. 3) Subjects whose total testosterone levels in blood are 250 ng/dL or over. 4) Subjects whose BMI are less than 30. 5) Subjects who can make self-judgment and are voluntarily giving written informed consent.

Exclusion criteria

Exclusion criteria: 1) Subjects who contract sexual dysfunction (erectile dysfunction, etc.). 2) Subjects who contract, are under treatment for serious diseases (e.g., diabetes, kidney and liver disease, and heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder. 3) Subjects who have a chronic disease and regularly use medications. 4) Subjects who have a history and/or a surgical history of digestive disease affecting digestion and absorption. 5) Subjects who are judged as unsuitable for the current study by screening test. 6) Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims). 7) Subjects who have excessive alcohol intake more than approximately 20 g / day of pure alcohol equivalent or habit of drinking 4 or more days per week. 8) Subjects who can't stop drinking from a day before each measurement. 9) Subjects who have declared allergic reaction to ingredients of test food. 10) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism. 11) Subjects who are shiftworker and/or midnight-shift worker. 12) Subjects who plan to travel abroad, including overseas travel, during test periods. 13) Subjects who have donated over 200 mL of blood and/or blood components within the last 4 weeks prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study. 14) Subjects who are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study. 15) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.

Design outcomes

Primary

MeasureTime frame
questionnaire

Countries

Japan

Contacts

Public ContactYoshika Komori

KSO Corporation Sales department

eigyou27@kso.co.jp03-3452-7733

Outcome results

None listed

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