The Impact of OliPhenolia® Supplementation on Exercise Induced Inflammation and Functional Movement in Humans.

This research proposal follows on from previously undertaken work investigating a commercially available olive derived product (OliPhenolia®) on potential exercise / functional benefits for healthy adults. Previous research investigated a dose response bioavailability of the main polyphenol in OliPhenolia® and related metabolites. Based on this data, the current study will aim to investigate, for the first time, whether the polyphenols in the product can positively influence exercise specific inflammation which may be pertinent to improving exercise recovery and is of current scientific interest. As such this research aims to understand the short term (Phase 1) and longer term (Phase 2) use of OliPhenolia® on acute recovery from a standard exercise bout. Research questions: 1. Does an acute dose of OliPhenolia® reduce exercise associated inflammation markers and enhance functional recovery in healthy adult humans? 2. Does a consecutive 16 day intake of OliPhenolia® reduce exercise associated inflammation markers and enhance functional recovery in healthy adult humans? 3. Does a continued intake of OliPhenolia® during the recovery period after the exercise bout further amplify functional benefits compared experimental control? Proposed methodology: Phase 1 - To answer research question 1, following a randomisation procedure, participants will be allocated product (OliPhenolia®) or colour and taste matched placebo. A single serve of product (no more than 1.5 mg/kg of hydroxytyrosol (HT) via OliPhenolia®) or placebo will be provided \~40 minutes prior to a standardised exercise protocol. Resting wholeblood samples will be collected at 0 (baseline) +1, +24, +48 and +72 hours following the exercise bout to identify the impact of an acute dose of OliPhenolia® has on selected inflammatory biomarkers. This phase will be a placebo-controlled crossover design and therefore after a ≥7 day wash out period, participants will return to the exercise laboratory (Compass House Human Physiology laboratories, Anglia Ruskin University, Cambridge), supplement the alternate product and repeat the experimental protocol as outlined above. Phase 2 - To answer research question 2, having completed Phase 1 (and following another ≥7 day wash out period), all participants will continue onto Phase 2, maintaining their previously assigned product, but this time will continue supplementation for 16 consecutive days. Phase 2 is therefore a parallel placebo-controlled design that focusses on a chronic supplementation of OliPhenolia®. Participants will consume one serve of either product or placebo twice daily for 16 days. After 16 days of supplementation participants will return to the exercise laboratory, and in the same manner as Phase 1, consume a single dose of their assigned product or placebo \~ 40 minutes prior to the standardised exercise protocol. Resting wholeblood samples will be collected following exercise at baseline, +1, +24, +48 and +72 hours. To answer research question 3, all participants will be informed that they may be asked to consume an additional three days supplementation in a random manner (total 19 days). To limit participant burden 50 % of the experimental group (those that have been supplementing OliPhenolia®) and placebo group will continue supplementing two doses daily for the three days following the standardised exercise protocol (the three days where blood samples occur) in order to understand if a sustained course of OliPhenolia® can reduce the time taken for inflammatory mediators to return to baseline values.

NCT Number	NCT07008586
Lead Sponsor	Anglia Ruskin University Collaborators: Fattoria La Vialla di Gianni, Antonio e Bandino Lo Franco Soc. Agr. Sempl.
Conditions	Healthy
Enrollment	18 participants
Start Date	2025-07-01
Primary Completion	2025-11-30 (estimated)
Study Completion	2025-12-10 (estimated)
Updated on ClinicalTrials.gov	2026-03-27