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Effects of consumption of anserine on fatigue in healthy Japanese subjects

Effects of consumption of anserine on fatigue in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study - Effects of consumption of anserine on fatigue in healthy Japanese subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000048173
Enrollment
44
Registered
2023-12-17
Start date
2022-06-28
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 Japanese subjects

Interventions

Food containing anserine Duration: Eight weeks The placebo food Duration: Eight weeks

Sponsors

ORTHOMEDICO Inc.
Lead Sponsor
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Men or women 3. Subjects aged 20 or more and less than 60 4. Healthy subjects 5. Subjects who easily feel fatigue due to usual work 6. Subjects who are judged as eligible to participate in the study on the physician by result of Beck Depression Inventory-II (BDI2) at screening (before consumption; Scr) 7. Subjects who are judged as eligible to participate in the study by the physician

Exclusion criteria

Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. Subjects who are currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, lactation, or planning to become pregnant 8. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 9. Subjects who are judged as ineligible to participate in the study by the physician 10. Subjects whose working form are irregular (subjects whose number of working days vary every week, and who do not have a series of at least three days per week) 11. Subjects whose ifestyles are irregula (whose habits vary every day such as dietary habits, exercise habits, and sleeping habits) 12. Subjects who drink to excess (average of more than about 20 g/day as absolute alcohol intake) 13. Subjects who are undergoing medical treatment or have a medical history of chronic fatigue syndrome 14. Subjects who take food containing functional ingredients which may influence fatigue or stress in daily

Design outcomes

Primary

MeasureTime frame
Subjective evaluation of fatigue

Countries

Japan

Contacts

Public ContactNaoko Suzuki

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

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