Tokyo, Feb. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060625) titled 'Effect of test foods on ease of intake and gastrointestinal symptoms during exercise' on Feb. 9.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Morinaga & Co., Ltd.
Condition:
Condition - Healthy male
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To compare the ease of intake and effects on gastrointestinal symptoms of nutritional supplements used during exercise
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Test food 1
Interventions/Control_2 - Test food 2
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male
Key inclusion criteria - 1. Male university students belonging to a track and field club (or equivalent) who specialize in long-distance running of 5000m or longer.
2. Individuals aged 18 to less than 26 years at the time of obtaining informed consent.
3. Individuals whose personal best record in an official 5000m race within the past year is between 14 minutes 00 seconds and 15 minutes 30 seconds.
4. Individuals who agree not to change their dietary habits during the study period.
5. Healthy individuals with no chronic physical diseases.
6. Individuals who have received a full explanation regarding the purpose and content of the study, possess the capacity to consent, fully understand the study, voluntarily desire to participate, and are able to provide written consent.
7. Individuals able to undergo measurements on the designated dates.
Key exclusion criteria - 1. Individuals with symptoms of any chronic disease.
2. Individuals with a history or current history of severe hepatic, renal, cardiac, pulmonary, or hematological disorders.
3. Individuals with comorbidities or a history of gastrointestinal diseases (however, a history judged by the principal investigator not to affect study participation is acceptable).
4. Individuals with food allergies (including a history of such allergies).
5. Individuals with alcohol dependence or other psychiatric disorders.
6. Individuals with severe anemia.
7. Individuals with a smoking habit.
8. Individuals likely to change their lifestyle habits during the study period (e.g., night shifts, long-term travel).
9. Individuals planning to start taking new Foods with Health Claims or supplements during the study period.
10. Individuals who have had a period of training interruption due to injury lasting 1 week or more within the past 2 months.
11. Individuals who have received treatment requiring hospitalization within the past 6 months.
12. Individuals currently participating in other human studies, or within 3 months after participating in other human studies.
13. Others judged by the principal investigator to be inappropriate for this study.
Target Size - 6
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 05 Day
Date of IRB - 2026 Year 02 Month 05 Day
Anticipated trial start date - 2026 Year 02 Month 10 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=R000069279
Disclaimer: Curated by HT Syndication.
