Effect of a Supplement Containing Olive Leaf Extract and Vitamins on Performance of Male Elite Cyclists
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Visual Analogue Scales for self reported performance over 3 days of intense exercise training between the test group and the placebo group
研究概览
简要总结
The study focuses on olive leaf extract, particularly its active component, Oleuropein, which has shown promise in enhancing energy metabolism and muscle performance in previous studies. Despite the existing evidence on the individual effects of olive leaf extract and various vitamins, there is a lack of data on their combined effects, especially in elite athletes. Therefore, the study aims to assess whether this supplement can positively influence perceived endurance, performance, mood, vitality, and fatigue during intensive training.
The study is a randomized, double-blind, placebo-controlled trial involving up to 40 male professional cyclists aged 21 to 36 years. Participants will be randomly assigned to either the test group, receiving the supplement, or the placebo group. The study will unfold over a 10-day period, including a baseline phase without the supplement and an intervention phase where participants will consume the product before training sessions.
The primary objective is to demonstrate that the supplement positively affects perceived endurance compared to a placebo. The primary endpoint will measure differences in average perceived endurance over three days of intense training. Secondary objectives include evaluating the effects of the supplement on perceived performance, mood, alertness, and physiological metrics (heart rate, power, cadence, and speed).
Participants will fill out questionnaires to assess their perceived endurance, performance, and mood before and after training sessions. Data on physiological performance will be collected through devices monitoring heart rate and other metrics. The study will employ mixed generalized linear regression models for statistical analysis, with a focus on superiority testing.
The study poses minimal risk to participants, as the investigational products have been previously tested for safety. No direct health benefits are anticipated from participation, but the research may contribute valuable insights into athletic performance enhancement.
Data collected will be securely managed and anonymized, adhering to Good Clinical Practices (GCP) and local regulations. Participants will be informed about the study's procedures and will provide informed consent prior to enrollment.
In summary, the NutriRide study seeks to explore the potential benefits of a supplement containing olive leaf extract and vitamins on the performance of elite male cyclists, aiming to fill gaps in current research on dietary interventions in sports performance.
详细描述
Olive leaf extract, particularly its active component Oleuropein, is of particular interest to the investigators due to the findings of a pre-clinical study, which demonstrated that this natural bioactive compound from olive leaf extract (OLE) enhanced energy metabolism, improved muscle performance, and reversed muscle decline. Furthermore, the clinical efficacy of OLE in supporting muscle energy metabolism has been validated in healthy adults. Other nutrients, such as B vitamins and guarana seed extract, have also been identified as essential for mitochondrial function and energy metabolism, improving attention, memory, mood, and alertness, particularly after intense exercise.
This study aims to build on these findings by administering a to professional cyclists a supplement rich in olive leaf extract, vitamins, and guarana seed extracts during their training camp and assessing its impact on their perceived endurance and performance.
The rationale for this project is grounded in the lack of available data on the combined effects of compounds such as OLE, B vitamins, magnesium and guarana extract, despite previous literature describing their individual effects on energy. The selection of professional cyclists as the study population is based on their high level of fitness and the rigorous physical demands they face during training. This makes them an ideal group for evaluating the potential benefits of the product on endurance and performance, and for generating new evidence on the potential advantages of such supplementation during the training phase of athletes.
The study involves the administration of a product and a placebo, both of which are water-based shots containing. Potential risks include adverse reactions to the product, although the ingredients have been tested in previous studies and found to be safe. Participants may experience discomfort from filling out the questionnaire 12 times in total.There are no direct health benefits expected for participants. The study aims to contribute to the scientific understanding of the effects of olive leaf extract on endurance and performance, which could benefit the wider athletic community. The study is considered to be of minimal risk due to the non-invasive nature of the procedures and the established safety profile of the investigational products.
The primary objective is to evaluate the superiority of the product supplemented with olive leaf extract and vitamins over the placebo in improving average perceived endurance after 3 days of intense exercise training. The secondary objectives of the study are to evaluate the effects of the supplement compared to placebo and baseline on:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 36 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males aged 21-36 years, inclusive, at enrolment.
- •Able to understand and to sign a written informed consent prior to study enrolment.
- •Willing and able to comply with the requirements for participation in this study.
排除标准
- •Currently participating in another interventional research study.
- •Family or hierarchical relationships with the research team members.
- •Any known/suspected food allergies. As reported by participant.
结局指标
主要结局
Visual Analogue Scales for self reported performance over 3 days of intense exercise training between the test group and the placebo group
时间窗: From Day 5 to Day 7 (included)
The difference in average perceived endurance will be assessed through Visual Analogue Scales over 3 days of intense exercise training between the test group that received a product supplemented with olive leaf extract and vitamins and the placebo group
次要结局
- Visual Analogue Scales (VAS) on the difference in average perceived performance between the test group and the placebo group(Day 5 to Day 7 (included))
- Bond-Lader Visual Analogue Scales (BL-VAS) © on subjective measures of mood and alertness after intense physical activity and their recovery overnight(Day 5 to Day 7 (included))
- Difference in average heart rate, power, cadence & speed, over 3 days of intense exercise training between the test group and the placebo group.(Day 5 to Day 7 (included))
- Visual Analogue Scales (VAS) on average perceived endurance and performance, over 3 days of intense exercise training between the baseline and the intervention periods.(Day 1 to day 7 (included))
- Bond-Lader Visual Analogue Scales (BL-VAS) © on average mood and alertness after intense physical activity and their recovery overnight(Day 1 to day 7 (included))
- Difference in average heart rate (Wahoo Trackr Heart Rate Monitor Chest Strap), power (SRAM Red AXS Quarrq power meter), cadence & speed (Wahoo Bolt V2 Bike computer), between the baseline and the intervention per(Day 1 to day 7 (included))
- Visual Analogue Scales (VAS) on perceived endurance and performance during intense physical activity(Day 5 to Day 7 (included))
- Difference in overtime heart rate, power, cadence & speed, over 3 days of intense exercise training between the test group and the placebo group.(Day 5 to Day 7 (included))