Tokyo, Nov. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059719) titled 'Effects of Test Beverage Consumption on Health Benefits' on Nov. 11.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Mizkan Holdings Co., Ltd.
Condition:
Condition - Healthy person
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To assess the health-promoting effects of four-week test beverage consumption.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Test beverage consumption twice daily for four weeks
Interventions/Control_2 - Placebo beverage consumption twice daily for four weeks
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1. Individuals aged 20 to 65 years who do not meet the exclusion criteria.
2. Individuals who understand the contents of the informed consent explanation and can provide written consent voluntarily.
3. Individuals who are not continuously consuming beverages containing the main ingredients of the test beverage.
Key exclusion criteria - 1. Individuals with a history of serious diseases of the brain, nervous system, cardiovascular system, or other severe disorders, or those currently under treatment (including individuals taking prescribed medications).
2. Individuals with a history of seizures (such as loss of consciousness, coma, or convulsions) due to neurological disorders.
3. Individuals who have difficulty performing essential evaluation items in this study due to hearing or visual impairments.
4. Individuals who are currently pregnant or breastfeeding.
5. Individuals who are currently participating in another clinical trial, or who have participated in another clinical trial within two months prior to obtaining consent.
6. Individuals judged as inappropriate for participation by the principal investigator.
Target Size - 120
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2024 Year 10 Month 25 Day
Date of IRB - 2024 Year 11 Month 12 Day
Anticipated trial start date - 2024 Year 12 Month 15 Day
Last follow-up date - 2025 Year 02 Month 25 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068268
Disclaimer: Curated by HT Syndication.