Tokyo, July 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062199) titled 'The effects of alfa-cyclodextrin on the intestinal environment and endurance capacity' on July 10.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Juntendo University
Condition:
Condition - Healthy people
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to assess the effect of alfa-cyclodextrin supplementation on the intestinal environment and endurance capacity of male university long-distance runners.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - alfa-cyclodextrin 1 g/day, 4 weeks
Interventions/Control_2 - alfa -cyclodextrin 2 g/day, 4 weeks
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male
Key inclusion criteria - 1. University student
2. Male athletes belonging to the track and field club's long-distance division
3. Individuals capable of completing all study procedures, including supplementation and measurements
4. Individuals who fully understand the study after receiving a thorough explanation and have provided written informed consent
Key exclusion criteria - 1. Individuals with a history or current diagnosis of severe cardiac, hepatic, renal, or gastrointestinal disease.
2. Individuals with a known allergy to the investigational product (or its ingredients).
3. Individuals currently participating in another clinical trial of a food product or pharmaceutical, or who have participated in one within 4 weeks prior to screening.
4. Individuals who plan to change their club affiliation or competitive discipline, or to suspend their athletic activities (e.g., due to leaves of absence or retirement) during the study period.
5. Individuals who have undergone major surgery (e.g., colonoscopic surgery, cholecystectomy, or gastric bypass) that could affect gastrointestinal structure, function, or study outcomes within 6 months prior to obtaining informed consent.
6. Individuals judged by the principal investigator or sub-investigator to be unsuitable for participation in this study for any other reason.
Target Size - 36
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2026 Year 06 Month 09 Day
Date of IRB - 2026 Year 06 Month 09 Day
Anticipated trial start date - 2026 Year 06 Month 17 Day
Last follow-up date - 2026 Year 08 Month 15 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071179
Disclaimer: Curated by HT Syndication.