Effect of a Supplement Containing Olive Leaf Extract and Vitamins on Performance of Male Elite Cyclists

Summary

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.

Conditions

• Supplement
• Endurance Cycling Performance
• Endurance Exercise
• Performance

Interventions

DIETARY_SUPPLEMENT

Pre-activity shot

Water-based shot containing olive leaf extract (100mg Oleuropein), vitamins, and other active ingredients. The product will be provided in sterilized Nalgene bottles of 60 mL, equivalent to one dose. Participants will consume one dose of the test product before their training session on each intervention day (Day 5, Day 6, and Day 7).

DIETARY_SUPPLEMENT

Placebo

Water-based shot with similar appearance and taste but without the active ingredients of the test product. The placebo will be provided in sterilized Nalgene bottles of 60 mL, equivalent to one dose. Participants will consume one dose of the placebo before their training session on each intervention day (Day 5, Day 6, and Day 7).

Sponsors & Collaborators

• UCAM university

  collaborator UNKNOWN

• Société des Produits Nestlé (SPN)

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

36 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-01-07

Primary Completion

2025-01-14

Completion

2025-01-14

Countries

• Spain

Study Locations