STUDY PROTOCOL article
Front. Med.
Sec. Family Medicine and Primary Care
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1653559
This article is part of the Research TopicClinical Evidence of Dietary Supplements as Support for Medical Therapy and PrognosisView all articles
Effect of Pinus koraiensis leaf extract on fatigue reduction and exercise performance: study protocol for a randomized, double-blind, placebocontrolled clinical trial
Provisionally accepted
- 1Korea Institute of Oriental Medicine (KIOM), Daejeon, Republic of Korea
- 2Huons N, Gyeonggi, Republic of Korea
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Background: Previous research has shown that Pinus koraiensis leaf (PKL) extract exhibits promising anti-fatigue potential in mice, showing improved exercise endurance, decreased stress-related biochemical markers, and enhanced antioxidant activity. Based on this previous animal study, the present study aims to evaluate the efficacy of PKL extract on fatigue reduction and exercise performance in healthy adults with moderate to severe fatigue. Method and analysis: This randomized, double-blind, placebo-controlled clinical trial will enroll volunteers who meet the eligibility criteria, specifically those with a Fatigue Severity Scale (FSS) score of 27 or higher, indicating clinically significant fatigue. Eligible participants will be randomly assigned to either the PKL extract or placebo group. The intervention will consist of daily consumption of the assigned investigational product for 8 weeks, with evaluations conducted at 4-week intervals. Primary outcome measures include the Fatigue Severity Scale (FSS) and time to exhaustion during a treadmill exercise test. Secondary outcomes include blood fatigue markers, exercise performance parameters, rating of perceived exertion, visual analogue scale for fatigue, and grip strength. Discussion: This clinical trial aims to develop PKL extract as a functional health food ingredient for fatigue improvement. The findings will provide evidence regarding the efficacy of PKL extract for alleviating fatigue and enhancing exercise performance in humans. Trial registration number: Clinical Research Information Service KCT0010247 (https://cris.nih.go.kr/cris/search/detailSearch.do?seq=29219)
Keywords: Pinus koraiensis, Pine leaf extract, Fatigue, exercise performance, Dietary Supplements, Functional Food, Clinical trial protocol
Received: 25 Jun 2025; Accepted: 22 Aug 2025.
Copyright: © 2025 Choi, Yang, Yoon, Kim, Kim and Lee. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Sang-Yoon Kim, Huons N, Gyeonggi, Republic of Korea
Mi Young Lee, Korea Institute of Oriental Medicine (KIOM), Daejeon, Republic of Korea
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.