Tokyo, Oct. 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059502) titled 'Confirmation of the fatigue improvement effects of continuous intervention with treatment programs and beverages aimed at fatigue recovery' on Oct. 22.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Placebo
Primary Sponsor:
Institute - Ezaki Glico Co., Ltd.
Condition:
Condition - Healthy Japanese
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To confirm the effects of continuous consumption of a dedicated beverage on fatigue recovery during the implementation of a continuous treatment program.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Duration: 15 days
Test product: Citric acid drink
Administration: Prior to performing the standard program and simplified program, dissolve the powder (4.4 g) in 100 mL of water (refrigerated) and drink it.
Interventions/Control_2 - Duration: 15 days
Test product: Water
Administration: Prior to performing the standard program and simplified program, drink 100 mL of water (refrigerated).
Eligibility:
Age-lower limit - 30
years-old
Gender - Male and Female
Key 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
Key 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
Target Size - 70
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 10 Month 22 Day
Date of IRB - 2025 Year 10 Month 22 Day
Anticipated trial start date - 2025 Year 10 Month 22 Day
Last follow-up date - 2025 Year 12 Month 19 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068060
Disclaimer: Curated by HT Syndication.
