Healthy Japanese
Conditions
Interventions
Duration: 15 days Test product: Hesperidin drink Administration: Prior to performing the standard program and simplified program, dissolve the powder (4.4 g) in 100 mL of water (refrigerated) and dr
Sponsors
Ezaki Glico Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Individuals aged 30 or more and less than 60 4. Healthy individuals 5. Individuals who have received an explanation of this study, understand its content, and are able to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Individuals who undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are undergoing treatment for the following chronic conditions: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, heart disease (e.g., myocardial infarction, angina pectoris), autonomic dysfunction, or other chronic diseases 4. Individuals who taking antihypertensive drug 5. Individuals who are allergic to medicines or foods related to the test product 6. Individuals who are pregnant, lactating, or planning to become pregnant during this study 7. Individuals who are unable to receive the treatment administered in this study, or who are prohibited from doing so by a physician 8. Individuals who are currently participating in other studies related to fatigue recovery 9. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 10. Individuals who are judged as ineligible to participate in this study by the principal investigator or the study request manager
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in fatigue Visual Analogue Scale (VAS) from baseline (pre-treatment on Day 1) to pre-treatment on Day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in fatigue VAS from baseline (post-treatment on Day 1) to pre-treatment on Day 15 2. Changes in fatigue VAS from baseline (pre-treatment and post-treatment on Day 1) to Day 8 and post-treatment on Day 15 3. Changes in heart rate, low frequency (LF)/high frequency (HF), Coefficient of variation of R-R interval (CVR-R), total power (TP), coefficient of component variance TP (ccvTP), muscle hardness, and salivary cortisol from baseline (pre-treatment and post-treatment on Day 1) to Day 8 and pre- and post-treatment on Day 15 4. Changes in feeling calm/relaxed or anxious/tense VAS and feeling refreshed or depressed VAS from baseline (the day before the intervention start) at each time point from the day of intervention start through Day 14 5. Measured values of fatigue VAS, heart rate, LF/HF, CVR-R, TP, ccvTP, muscle hardness, and salivary cortisol at Day 8 and pre- and post-treatment on Day 15 (intra-group comparisons with pre- and post-treatment on Day 1) 6. Measured values of fatigue VAS, heart rate, LF/HF, CVR-R, TP, ccvTP, muscle hardness, and salivary cortisol at post-treatment on Day 1 (intra-group comparison with pre-treatment on Day 1) 7. Measured values of fatigue VAS, heart rate, LF/HF, CVR-R, TP, ccvTP, muscle hardness, and salivary cortisol at post-treatment on Day 15 (intra-group comparison with pre-treatment on Day 15) | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed