The Impact of OliPhenolia® Supplementation on Exercise Induced Inflammation and Functional Movement in Humans.
NCT07008586 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2026-03-27
Summary
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.
Conditions
- Healthy
Interventions
- DIETARY_SUPPLEMENT
-
OliPhenolia®
Olive derived hydroxytyrosol will be ingested via a commercially available olive fruit wastewater (OliPhenolia®) in a dose relative to participant body mass.
- DIETARY_SUPPLEMENT
-
Taste and appearance matched placebo
Equal parts prune juice (Sunsweet California Prune Juice, Yuba City, CA, USA), diet cola (Tesco Cola, Tesco, UK) and tonic water (Tesco low calorie Indian tonic water, Tesco, UK).
Sponsors & Collaborators
-
Fattoria La Vialla di Gianni, Antonio e Bandino Lo Franco Soc. Agr. Sempl.
collaborator UNKNOWN -
Anglia Ruskin University
lead OTHER
Principal Investigators
-
Justin D Roberts, Professor · Anglia Ruskin University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 21 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-07-01
- Primary Completion
- 2025-11-30
- Completion
- 2025-12-10
Countries
- United Kingdom
Study Locations
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