- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02787733
The Effect of an Orange Peel Extract on Exercise Performance
Establishing the Effect of Long-term Orange Peel Extract Supplementation on Exercise Performance and Recovery
Rationale: Numerous studies have shown the positive effect of a healthy diet and regular moderate exercise. Although, exercise has also been correlated with an increase in reactive oxygen species (ROS) production and a higher incidence of injury. ROS production seems to induce muscle damage, which reduces muscle performance and induces fatigue. Increasing muscle recovery could be an effective way to increase exercise performance. Several food ingredients have been of growing interest due to their specific functioning on the human body. Citrus flavonoids are abundantly available in citrus fruits. Prior studies show a positive effect of citrus flavonoids on endothelial function, by promoting vasodilation. In addition it has a positive effect on the nitric oxide (NO) synthesis, a known compound in regulating endothelial response. This capacity of citrus flavonoids could be useful in stimulating performance and recovery after exercise. Additionally, the ability of scavenging ROS could reduce muscle damage caused by exercise induced oxidative damage.
Objective: Determine the 4-week effect of daily citrus flavonoid supplementation on exercise recovery and performance.
Study design: Randomized, double-blind, placebo-controlled study with parallel design, in which 40 subjects engage in three exercise sessions. The sessions will be subdivided into a pre-test and test 1 and 2. Between test 1 and 2, participants receive daily for 4 weeks citrus flavonoid supplement or a placebo. Each day, subjects should consume 2 capsules each morning, containing in total 500 mg of citrus flavonoids or 500 mg placebo.
Study population: The subjects will be healthy normal weight trained males, with an age of 18 - 25. Additionally, subjects are non-smokers and free of a medication.
Intervention: Participants will be randomly placed in either the citrus flavonoid or placebo group. Participants will be instructed to ingest 2 capsules each morning for 4 consecutive weeks. Each capsule equals to 250 mg of citrus flavonoids or cellulose in case of the placebo treatment.
Main study parameters/endpoints: The main study parameter is the average amount of work load produced during the 10-minute time trail test. In addition, oxygen per minute will be determined as well as the heart rate. Finally, for each test, the subjective rating of perceived exertion (RPE) will be determined during the pre-test and test 1 and 2 by using a Borg scale.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Gelderland
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Arnhem, Gelderland, 네덜란드, 6816VD
- InnoSportLab Papendal
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Trained participants, defined as engaging at least 3 times a week in moderate to high physical activity for a minimum of 30 minutes
- Non-smoking, defined as no smoking for the last 6 months
- Participants are capable and willing to give written informed consent voluntarily after receiving detailed information from the researchers
Exclusion Criteria:
- Cardiovascular complications
- Extreme BMI (i.e. lower than 18 or higher than 30)
- Use of medication
- Use of antioxidants, minerals and vitamin supplements available in pharmacies, drugstores, food markets or in alternative medicine
- Abuse of products; alcohol (> 20 alcoholic consumptions per week) and drugs
- Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator) in the 180 days prior to the study
- Failure to comply prohibited intake of hesperidin containing food products during study period. A list with forbidden food products will be provided to participant
- History of any side effects towards the intake of flavonoids or citrus fruits
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Citrus flavonoid
Citrus peel extract containing >90% flavonoids
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Daily dose of 500mg divided over two capsules
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위약 비교기: Placebo
Identical looking placebo
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Daily dose of 500mg divided over two capsules
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Average force output (Watts) in endurance cycling exercise after pre-exhaustive exercise
기간: 4 week
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Average force output is measured through a cycle ergometer
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4 week
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Maximum oxygen uptake (ml/kg/min) in endurance cycling exercise after pre-exhaustive exercise
기간: 4 weeks
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Maximum oxygen uptake is measured through an oxygen mask
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4 weeks
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Citrus flavonoid에 대한 임상 시험
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University of Palermo알려지지 않은
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Chung Shan Medical UniversityTCI Co., Ltd.모병