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Effect of ingestion of fermented black maca-containing food "Aged black maca Macarhythm" on fatigue and QOL Placebo-controlled, double-blind, randomized, controlled trial

Effect of ingestion of fermented black maca-containing food "Aged black maca Macarhythm" on fatigue and QOL Placebo-controlled, double-blind, randomized, controlled trial - Effect of ingestion of fermented black maca-containing food "Aged black maca Macarhythm" on fatigue and QOL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000043288
Enrollment
30
Registered
2022-06-17
Start date
2021-02-16
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 individuals

Interventions

Ingestion of study food for 4 weeks Ingestion of control food substance for 4 weeks

Sponsors

Miura Clinic, Medical Corporation Kanonkai
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Subjects of men and women aged 20 to 80 (2) Subjects who are tired on a daily basis (3) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing.

Exclusion criteria

Exclusion criteria: (1) Subjects with a history of liver disease, renal disease, digestive system disease, heart disease, respiratory disease, peripheral angiopathy, and other diseases that may affect the results of this study, or subjects with a history of surgery (2) Subjects with diseases currently being treated (3) Subjects who have been diagnosed with psychiatric disorders such as chronic insomnia, depression, anxiety disorders, and schizophrenia (4) Subjects with food and drug allergies (5) Subjects on a diet (6) Subjects with irregular lives (7) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period (8) Subjects who are continuously taking medicines (including OTC and prescription medicines) (9) Subjects taking excessive alcohol intake (10) Subjects who cannot stop drinking from the day before the test to the day of the test (11) Pregnant, lactating, or prospective pregnant or lactating subjects during the study period (12) Subjects who are participating in or will participate in other clinical trials at the start of this study, and within 4 weeks after the end of the study. (13) Other subjects judged by the investigator to be inappropriate

Design outcomes

Primary

MeasureTime frame
CFS (Chalder Fatigue Scale) Fatigue VAS QOLVAS Athens Insomnia Scale OSA sleep questionnaire Urine frequency

Countries

Japan

Contacts

Public ContactMakoto Terashima

Oneness Support Co., Ltd. Clinical Trial Division

mterashima@oneness-sup.co.jp0648018917

Outcome results

None listed

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