Effects of consumption of the test food on the coldness of the body in healthy Japanese

UMIN ID: UMIN000054039

Registered date:02/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy Japanese
• Date of first enrollment: 2024/04/02
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Duration: 12 weeks Test food: Capsule containing dried Aurantiochytrium Administration: Take one capsule with water once daily before sleep *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 Administration: Take one capsule with water once daily before sleep *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: 1. The area under the curve (AUC) of the right palmar skin surface temperature from immediately to 30 minutes after cold water load at examination 12 weeks after consumption (12w)
• Secondary Outcome: 1. The measured values of the right palmar skin surface temperature at each measurement point, and the changes from measurements before and immediately after cold water load at 12w 2. The recovery rate of the right palmar skin surface temperature at each measurement point (except before and immediately after cold water load) at 12w 3. The AUC of the left palmar skin surface blood flow from immediately to 30 minutes after cold water load, the measured values at each measurement point, and changes from measurements before and immediately after cold water load at 12w 4. The subjective cold-related symptoms measured by visual analogue scale (VAS) before and 30 minutes after cold water load at 12w

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Individuals who 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. are undergoing medical treatment or have a medical history of thyroid disease 5. are undergoing medical treatment or have a medical history of aspirin hypersensitivity 6. have hypotension (a systolic blood pressure less than 100 mmHg) 7. are undergoing medical treatment for anemia or cold sensitivity 8. are a smoker 9. cannot use water that flows out of the water pipes in the cold season (December~February) (whose fingertips change color to purple or white when these hands are put in water) 10. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 11. take food/beverage with functional ingredients which may influence the thermoregulation (e.g., monoglucosyl hesperidin, polyphenols from ginger, 6-gingerol, 6-shogaol, piperines from Piper longum, ellagic acid, L-citrulline, flavonoid from Crataegus laevigata, hyperin, capsaicin, eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), or camelliasaponin B2) 12. are taking or using medications (including herbal medicines) and supplements 13. are allergic to medicines and/or the test product related products 14. are pregnant, lactating, or planning to become pregnant during this study 15. have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate another study during this study 16. 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: SoPros Inc.