Tokyo, Oct. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059373) titled 'Effects of the test food on swelling in healthy Japanese' on Oct. 14.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - -
Condition:
Condition - Healthy adult female
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to investigate the test food on swelling.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Consumption of test beverage for 8 weeks
Interventions/Control_2 - Consumption of control beverage for 8 weeks
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Female
Key inclusion criteria - Healthy Japanese women who are 20 to 49 years of age at the time of consent.
Those who feel swelling.
Participants who received sufficient explanation about the purpose and content of the trial, had the ability to consent, volunteered to participate after understanding it well, and agreed to participate in the trial in writing.
Key exclusion criteria - Participants currently taking medication on a daily basis
Participants suffering from a medical condition or requiring continuous medical visits or follow-up monitoring
Participants who regularly consume rooibos tea at least four days a week
Participants who do not like the test or control beverages
Participants who cannot discontinue the intake of health foods (including supplements), foods for specified health uses, foods with nutrient functions, or foods with functional claims during the study period.
Participants who cannot participate in all three designated measurement dates
Participants who cannot stop wearing tight-fitting clothing (skinny jeans, tights, etc.) on the day of the measurement
Participants who cannot remove makeup from their cheeks immediately before the measurement
Participants who are pregnant, intend to become pregnant during the study period, or are breastfeeding
Target Size - 60
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 08 Month 29 Day
Date of IRB - 2025 Year 09 Month 29 Day
Anticipated trial start date - 2025 Year 10 Month 14 Day
Last follow-up date - 2026 Year 04 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067906
Disclaimer: Curated by HT Syndication.