Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063051) titled 'Effects of Test Food Intake on Delayed-Onset Muscle Soreness and Blood Biomarkers of Muscle Damage Following Eccentric Exercise: A Double-Blind, Placebo-Controlled Crossover Study' on Oct. 1.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Kyushu Women's University
Condition:
Condition - No
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The effects of the test food on reducing muscle damage induced by eccentric exercise will be evaluated using subjective assessments of delayed-onset muscle soreness (DOMS) and blood biomarkers, including creatine kinase (CK).
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Full-dose of test food
Interventions/Control_2 - Half-dose of test food
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - 1) Healthy men and women aged 18-45 years
2) No use of other dietary supplements during the study period
3) No known allergies or chronic diseases
Key exclusion criteria - 1) Individuals who have, or have a history of, serious cardiovascular, hepatic, renal, respiratory, endocrine, or metabolic disorders.
2) Individuals with a history of serious illness requiring continuous medication.
3) Individuals who may be at risk of developing an allergic reaction related to the study intervention.
4) Individuals who are pregnant, breastfeeding, or planning to become pregnant during the study period.
5) Individuals who are otherwise deemed unsuitable for participation in the study by the study investigators.
Target Size - 24
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 27 Day
Date of IRB - 2026 Year 08 Month 04 Day
Anticipated trial start date - 2026 Year 10 Month 01 Day
Last follow-up date - 2026 Year 11 Month 20 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072183
Disclaimer: Curated by HT Syndication.