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

NCT06741163 | Completed

• 1 other identifier: 2414NR
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

performance; cycling; supplement; endurance; oleuropein

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scales for self reported performance over 3 days of intense exercise training between the test group and the placebo group

  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

  From Day 5 to Day 7 (included)

Secondary Outcomes (8)

• 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)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants will be randomly allocated to receive the placebo, which is a 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).

Dietary Supplement: Placebo

Intervention

EXPERIMENTAL

Participants will be randomly allocated to receive the test product, which is a 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: Pre-activity shot

Interventions

Pre-activity shot DIETARY_SUPPLEMENT

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).

Intervention

Placebo DIETARY_SUPPLEMENT

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).

Placebo

Eligibility Criteria

• Age: 21 Years - 36 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead
• UCAM university: collaborator

Study Sites (1)

Hotel Serawa Moraira

Moraira, 03724, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, two-arm parallel group study conducted in one center.

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 18, 2024
• Study Start: January 7, 2025
• Primary Completion: January 14, 2025
• Study Completion: January 14, 2025
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: IPD shared between November 2024 to May 2025
• Access Criteria: The study PI and the Scientific Lead will be able to access the IPD through regulated virtual access to the electronic data capture (medidata) and trial master file (Veeva). To access all sensitive files, a software-specific and cloud-specific password and granted access will be required. If necessary, any transfer of files between the company and Nestlé will be conducted through their secure server, ensuring the confidentiality and security of the data.

Locations

ES (1)