Tokyo, Dec. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060200) titled 'A randomized, double-blind, placebo-controlled, parallel-group comparative study to examine the effect of test food intake on heat acclimation' on Dec. 25.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Osaka Metropolitan University
Condition:
Condition - Healthy subjects
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The aim of this study is to verify whether combining exercise in a cool environment, a warm bath after exercise, and the intake of test food post-exercise can effectively enhance heat tolerance.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Intake of test food for two weeks
Interventions/Control_2 - Intake of placebo for two weeks
Eligibility:
Age-lower limit - 45
years-old
=
Gender - Male
Key inclusion criteria - 1. Healthy individuals
2. Males
3. Individuals aged 45 to 64 years at the time of consent
4. Individuals who have not participated in a regular exercise training program within the two years prior to the start of the study
5. Individuals who are able to participate in the study as specified, including exercise, hot baths, and blood sampling at the research facility
6. Individuals who have received a thorough explanation of the study and, after fully understanding it, have given their voluntary written consent
Key exclusion criteria - 1. Smokers
2. Obese individuals (body mass index 30 kg/m2 or higher)
3. Individuals with abnormalities requiring exercise restriction in a health checkup within the past year
4. Individuals who have been advised by a doctor not to engage in strenuous exercise
5. Individuals with allergies to test foods (soy or milk)
6. Individuals deemed inappropriate for participation by the research co-investigator (physician)
7. Individuals who answer "yes" to at least one of the seven questions on the physical activity risk screening sheet
Target Size - 32
Recruitment Status:
Recruitment status - Suspended
Date of protocol fixation - 2025 Year 08 Month 04 Day
Date of IRB - 2025 Year 09 Month 06 Day
Anticipated trial start date - 2025 Year 10 Month 22 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068718
Disclaimer: Curated by HT Syndication.