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A Study on the Effect of Food Containing Plant Extract on QOL -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-

A Study on the Effect of Food Containing Plant Extract on QOL -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study- - A Study on the Effect of Food Containing Plant Extract on QOL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000044186
Enrollment
50
Registered
2021-05-14
Start date
2021-05-15
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

Foods containing plant extract, 4 weeks consumption Foods not containing plant extract, 4 weeks consumption

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Healthy Japanese males and females aged 20 to 64 years-old. 2)Subjects who tend to feel tired easily in daily life. 3)Subjects who can make self-judgment and are voluntarily giving written informed consent.

Exclusion criteria

Exclusion criteria: Subjects (who) 1)are judged by doctors to have a high probability of chronic fatigue syndrome. 2)contract or are under treatment for serious diseases (e.g., liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, and/or other metabolic disease). 3)have a chronic disease and use medications. 4)contract or have a surgical history of digestive disease affecting digestion and absorption. 5)may have allergy to test foods. 6)have alcohol intake more than approximately 20 g/day of pure alcohol equivalent or a habit of drinking not less than 4 days a week. 7)can't stop drinking from 2 days before each measurement. 8) smoke 10 or more cigarettes a day, or cannot quit smoking during from waking to inspection completed. 9)use drugs, supplements, or functional foods associated with fatigue recovery. 10)are shiftworker, midnight worker and/or hard worker. 11)have regular hard exercise. 12) are pregnant or breast-feeding or planned to become pregnant during the study period. 13) have donated over 200 mL of blood and/or blood components within the last one month 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)are participating in or willing to participate in other clinical studies. 15)are judged as unsuitable for the current study by the investigator for other reasons.

Design outcomes

Primary

MeasureTime frame
QOL questionnaire

Secondary

MeasureTime frame
complexion

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