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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000051050
Enrollment
70
Registered
2023-05-14
Start date
2023-05-15
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

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

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Healthy males and females aged 30 to 49 years old. (2)Subjects who feel decreasing vitality in daily life. (3)Subjects who can make self-judgment and are voluntarily giving written informed consent.

Exclusion criteria

Exclusion criteria: Subjects (who) 1)have a probability of idiopathic chronic fatigue or chronic fatigue syndrome based on self-report. 2)have a chronic disease and regularly use medications. 3)have a probability of depression by CES-D scores, medical interview, etc. 4)with a history of and/or current sleep disorders. 5)contract or are under treatment for serious diseases (eg, liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, thyroid disease, adrenal disease and/or metabolic disease). 6)use supplements, functional foods, or drugs associated with fatigue recovery or lack of sleep. 7)have a history and/or a surgical history of digestive disease affecting digestion and absorption. 8)may have allergy to test foods. 9)are pregnant or planning to become pregnant or breastfeed during the study period. 10)have excessive alcohol intake more than 20 g/day of pure alcohol equivalent for more than 4 days a week. 11)can't stop drinking from 2 days before each measurement. 12)are under treatment for or have a history of drug addiction and/or alcoholism. 13)smoke 20 or more cigarettes a day, or cannot quit smoking during from waking to inspection completed. 14)are shiftworker, midnight worker and/or physical labor. 15)have regular hard exercise. 16)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. 17)are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study. 18)are judged as unsuitable for the current study by the investigator for other reasons.

Design outcomes

Primary

MeasureTime frame
Questionnaire on overall mood

Secondary

MeasureTime frame
Other 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