Tokyo, July 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058589) titled 'An Exploratory Study on the Effects of Short-Term Oligonol Supplementation on High-Altitude Training Adaptation in Female Long-Distance Runners' on July 28.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Toyo University
Condition:
Condition - Female Athletes
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study examines the potential physiological benefits of short-term Oligonol supplementation in healthy female long-distance runners undergoing high-altitude residence and training. Oligonol is a low-molecular-weight polyphenol derived from lychee. Specifically, the study examines its impact on anaemia-related biomarkers, psychophysiological stress and inflammatory responses, with the aim of evaluating its potential as a nutritional recovery and conditioning strategy under hypoxic conditions.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Participants will orally take one hard capsule containing 100 mg of Oligonol after breakfast and one after dinner (2 capsules per day), with water or lukewarm water. The supplementation period will be 9 days.
Interventions/Control_2 - Participants will orally take one hard capsule containing dextrin (placebo) after breakfast and one after dinner (2 capsules per day), with water or lukewarm water. The supplementation period will be 9 days.
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Female
Key inclusion criteria - (1) Written informed consent has been obtained from the participant.
(2) The participant is a healthy female aged 18 years or older.
(3) The participant does not plan to take any new supplements or health foods during the study period.
Key exclusion criteria - (1) Individuals with a current or past history of allergy to any component contained in the study food.
(2) Current smokers or individuals with a history of smoking within the past three months.
(3) Individuals who are pregnant, lactating, possibly pregnant, or planning to become pregnant or breastfeed during the study period.
(4) Individuals with gastrointestinal disorders that may impair nutrient absorption, such as malabsorption syndrome or a history of gastrectomy.
(5) Individuals receiving ongoing pharmacological treatment for any medical condition, including endocrine disorders.
(6) Individuals currently participating in another clinical or observational study, or planning to participate in one during the study period.
(7) Individuals deemed inappropriate for study participation by the principal investigator.
Target Size - 28
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 07 Month 22 Day
Date of IRB - 2025 Year 07 Month 22 Day
Anticipated trial start date - 2025 Year 08 Month 16 Day
Last follow-up date - 2025 Year 09 Month 15 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066990
Disclaimer: Curated by HT Syndication.