Healthy Japanese subjects
Conditions
Interventions
Duration: Single ingestion (two test periods) Test food: <
Active food>
Active tablet <
Placebo food>
Placebo tablet Administration: After completing the pre-consumption examination, take one active tablet with a drink such as water in period I. After washout period, take one placebo tablet with a d
Placebo tablet Administration: After completing the pre-consumption examination, take one placebo tablet with a drink such as water in period I. After washout period, take one active tablet with a d
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Subjects aged 20 or more and less than 65 4. Healthy subjects 5. Subjects who easily feel fatigue due to work such as office work 6. Subjects whose subjective fatigue measured by VAS is 40 mm or more
Exclusion criteria
Exclusion criteria: Subjects who / whose 1.are undergoing medical treatment or have a medical history of malignancy, heart failure, and myocardial infarction 2.anthropometric measurements, physical examination values, or laboratory values are D or above in the criteria category of the Japan Society of Ningen Dock 3.have a medical history of cardiopathy, a pacemaker, or an implantable cardioverter defibrillator 4.have treatment for chronic disease such as arrhythmia, hepatopathy, nephropathy, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension 5.are going a psychiatric medical institute / meet the criteria for a major depressive episode 6.are going a hospital / receive treatment / take medicines or health food to improve sleep or stress 7.usually take "Foods for Specified Health Uses," or "Foods with Functional Claims" 8.have a disease with constant medication / have a medical history of malignancy with medication (except for remission) 9.usually take medicines (including herbal medicines) and supplements 10.habitually take an energy drink once weekly or more 11.are allergic to medicines and/or the test food related products 12.work in late-night / sleep between 6 and 10 AM and get up between 6 and 8 PM once weekly or more 13.work in physical labor 14.have hormonal treatment / are diagnosed with menopausal syndrome by a doctor 15.are diagnosed with arrhythmia by a doctor 16.smoke / stopped smoking within one year before screening 17.usually drink more than an appropriate amount (about 20 g/day as absolute alcohol) 18.are pregnant, lactating, or planning to become pregnant during this trial 19.suffer from COVID-19 / are a close contact person 20.have been enrolled in other clinical trials within the last 28 days before the agreement to participate or plan to participate another trial during this trial 21.are judged from the interview to have difficulty receiving prescribed examination or complying with the restrictions 22.are judged as ineligible by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Momentary subjective fatigue level of subjects measured by visual analogue scale (VAS) after the workload 2. Momentary subjective fatigue level of subjects measured by VAS before the workload | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Subjective symptoms measured by VAS 2. Salivary markers 3. Heart rate | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed