Tokyo, July 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062146) titled 'Effect of Lactic Acid Bacteria Supplementation on Exercise-Induced Intestinal Inflammation' on July 6.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Meiji Co., Ltd.
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effect of lactic acid bacteria supplementation on exercise-induced intestinal inflammation compared with a placebo supplement.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Four consecutive days of endurance exercise combined with a lactic acid bacteria supplement for six days starting on the first day of exercise.
Interventions/Control_2 - Four consecutive days of endurance exercise combined with a placebo supplement for six days starting on the first day of exercise.
Eligibility:
Age-lower limit - 30
years-old
Gender - Male
Key inclusion criteria - 1. Male subjects aged 30 to 49 years
2. Subjects who voluntarily provided written informed consent
Key exclusion criteria - 1. Subjects with regular exercise habits within the past year
2. Subjects without a history of regular exercise for at least one year
3. Subjects receiving treatment for chronic diseases or with a history of serious disease
4. Subjects with musculoskeletal disorders
5. Subjects using implantable medical devices
6. Subjects with exercise restrictions
7. Subjects judged unsuitable for study participation by the study physician based on ECG results
8. Subjects with SBP >= 150 mmHg or DBP >= 100 mmHg
9. Subjects with milk or soy allergy
10. Subjects with BMI = 25.0
11. Current smokers
12. Subjects not participating in any other human studies
13. Subjects judged unsuitable for study participation by the principal investigator or study physician
Target Size - 12
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 05 Month 07 Day
Date of IRB - 2026 Year 05 Month 15 Day
Anticipated trial start date - 2026 Year 07 Month 12 Day
Last follow-up date - 2026 Year 09 Month 22 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071115
Disclaimer: Curated by HT Syndication.
