A verification study of the anti-stress effects of the test food

UMIN ID: UMIN000051777

Registered date:26/12/2024

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy Japanese subjects
• Date of first enrollment: 2023/08/01
• Target sample size: 44
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Duration: 12 weeks Test food: Active capsule Administration: Take four capsules per day with water without chewing *If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
Duration: 12 weeks Test food: Placebo capsule Administration: Take four capsules per day with water without chewing *If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.

Outcome(s)

• Primary Outcome: The Profile of Mood States 2nd Edition (POMS2)
• Secondary Outcome: The MOS Short-Form 36-Item Health Survey version 2 (SF-36v2), fatigue measured by visual analogue scale (VAS), 8-hydroxy-2'-deoxyguanosine (8-OHdG) level in the urine, salivary cortisol, diacron-reactive oxygen metabolites (d-ROMs), biological anti-oxidant potential (BAP)

Key inclusion & exclusion criteria

• Age minimum: 30years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude 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 diseases: 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, lactating, or planning to become pregnant during this trial 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 have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues 10. Subjects whose sleeping time or habit is irregular due to work such as a late-night shift 11. Subjects who have irregular lifestyles (such as diet, exercise, and sleep) 12. Subjects who are undergoing medical treatment for chronic fatigue syndrome or menopausal syndrome 13. Subjects who work in physical labor such as transportation of heavy objects 14. Subjects who are judged as ineligible to participate in this study by the physician

Related Information

• Primary Sponsor: ORTHOMEDICO Inc.
• Secondary Sponsor: Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
• Source(s) of Monetary Support: Maruha Nichiro Corporation