None listed
Conditions
Interventions
Oral ingestion of a test food (3 tablets in a day
8 weeks).
Oral ingestion of a placebo food (3 tablets in a day
8 weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Males and females aged 30 years or older but under 65 years at the time of obtaining consent to participate in the trial. 2) Individuals in good health with no chronic physical conditions. 3) Individuals who frequently experience shoulder strain or stiffness in daily life. 4) Individuals who have received sufficient explanation regarding the purpose and content of this trial, possess the capacity to consent, voluntarily volunteer to participate after fully understanding, and can provide written consent to participate in this trial. 5) Individuals who can attend the designated examination date and undergo the examination. 6) Individuals deemed suitable for participation in this trial by the principal investigator.
Exclusion criteria
Exclusion criteria: 1) Individuals using medical products. 2) Individuals suffering from shoulder joint disorders or similar conditions. 3) Individuals with a history or current condition of serious impairment affecting the eyes, digestive organs, liver, kidneys, heart, lungs, blood, or mental health. 4) Individuals who used a drug to treat a disease in the past 1 month. 5) Individuals whose BMI is over 30 kg/m2. 6) Individuals with drug and food allergies. 7) Individuals who currently have, or have had within the past three months, a habit of regularly consuming functional foods, health foods, or supplements that claim to improve blood flow or reduce fatigue, or that contain ingredients that could potentially affect test results; as well as individuals who plan to consume such products during the test period. 8) Individuals whose average weekly pure alcohol consumption exceeds 40 g/day for men and 20 g/day for women. 9) Individuals with possible changes of life style during the test period. 10) Individuals engaged in shift work or night work involving regular fluctuations in working hours. 11) Individuals who have a smoking habit. 12) Individuals who are or are possibly pregnant, or are lactating. 13) Individuals unable to restrict the use of massage, osteopathy, chiropractic, acupuncture, or the application of heat packs and hot compresses during exam periods. 14) Individuals who participated in other clinical studies in the past 3 months. 15) Individuals who are or whose family is engaged in healthy or functional foods. 16) Individuals who are unable to follow instructions from the study supervisor or who judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Shoulder Function Assessment Index | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary Evaluation Items 1)Patient-Reported Shoulder 36 (V1.3) 2)Muscle Hardness Measurement *Safety Evaluation Items 1)Blood Pressure/Pulse Rate 2)Weight/Body Fat Percentage/BMI 3)Hematological Tests 4)Blood Biochemical Tests 5)Urinalysis 6)Physician Interview/Adverse Event Assessment 7)Daily Activity Log | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed