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

NCT07008586 | Completed

• 1 other identifier: ETH2425-3172
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does an acute dose of OliPhenolia® reduce exercise associated inflammation markers and enhance functional recovery in healthy adult humans?
2. 2.Does a consecutive 16 day intake of OliPhenolia® reduce exercise associated inflammation markers and enhance functional recovery in healthy adult humans?
3. 3.Does a continued intake of OliPhenolia® during the recovery period after the exercise bout further amplify functional benefits compared experimental control?

Conditions

Healthy

Keywords

Hydroxytyrosol; Exercise; Inflammation; Mobility

Outcome Measures

Primary Outcomes (5)

• Interleukin 6

  Four days

• Interleukin 1 receptor antagonist

  Four days

• Transforming growth factor-beta

  Four days

• Lactate dehydrogenase

  Four days

• Superoxide dismutase

  Four days

Secondary Outcomes (9)

• Functional movement screen

  Four days

• Counter movement jump

  Four days

• Physical Readiness Questionnaire

  Four days

• Perceived Muscle soreness

  Four days

• Pain questionnaire

  Four days

Study Arms (2)

OliPhenolia

EXPERIMENTAL

Commercially available concentrated olive fruit wastewater (OliPhenolia®) will be provided in a dose relative to participant body mass. In this arm, to assess the acute effects, participants will consume an oral bolus of 1.0mg∙kg-1 olive derived hydroxytyrosol via OliPhenolia® ahead of the exercise test. Following a wash out and necessary cross-over, participants will consume two doses of 1.0mg∙kg-1 olive derived hydroxytyrosol via OliPhenolia® daily for 16 days to assess the chronic component of this study..

Dietary Supplement: OliPhenolia®

Placebo

PLACEBO COMPARATOR

In this arm, to assess the acute component, participants will consume a single oral bolus of placebo (matched for taste and appearance to OliPhenolia®) ahead of the exercise test. The volume of this will be prepared by an independent researcher to match the specific volume of OliPhenolia® required for each participant. Following a wash out and necessary cross-over, participants will consume two doses placebo (identical volume to the acute component) daily for 16 days to assess the chronic component of this study.

Dietary Supplement: Taste and appearance matched placebo

Interventions

OliPhenolia® DIETARY_SUPPLEMENT

Olive derived hydroxytyrosol will be ingested via a commercially available olive fruit wastewater (OliPhenolia®) in a dose relative to participant body mass.

OliPhenolia

Taste and appearance matched placebo DIETARY_SUPPLEMENT

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).

Placebo

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥ 21 in line with manufacturer recommendations.
• Written informed consent.
• Willingness and ability to conform to the full protocol (please see full protocol).
• Judged by the investigator to be in good health.
• To have a pre-study health screen signed off by the lead researcher.

You may not qualify if:

• Current or recent (within the last 4 weeks) engagement with a strict dietary regime i.e., vegetarian / vegan / ketogenic / paleolithic / high protein / weight loss.
• Any known issues with blood taking.
• Any known bleeding disorders.
• Any known allergy to olives, grapes, lemon, coca cola or prunes.
• Average alcohol use of \<21 glasses per week for men and \<14 glasses per week for women (on average for the last six months).
• Any drug or medicine abuse in the last six months
• Known cardiovascular disease, disease related to the immune system (including HIV and hepatitis) and / or the respiratory system.
• Known Diabetes Mellitus type I or type II.
• Known renal or liver issues or known thyroid dysfunction.
• Currently undertaking regular heavy and / or extreme exercise (please discuss with the lead researcher if you are unsure).
• Current smoker or stopped smoking for \<one month prior to the first visit.
• Current participation in any other clinical study within the month previous to the study start date (discuss with the lead researcher if unsure).
• Known pregnancy and / or lactation (women only)
• Uncertainty about the willingness or ability of the subject to comply with the protocol requirements.

Sponsors & Collaborators

• Anglia Ruskin University: lead
• Fattoria La Vialla di Gianni, Antonio e Bandino Lo Franco Soc. Agr. Sempl.: collaborator

Study Sites (1)

Cambridge Centre for Sport and Exercise Sciences, Anglia Ruskin University,

Cambridge, CB5 8DZ, United Kingdom

Location

Related Publications (1)

• Roberts JD, Lillis JB, Pinto JM, Chichger H, Lopez-Samanes A, Coso JD, Zacca R, Willmott AGB. The Effect of a Hydroxytyrosol-Rich, Olive-Derived Phytocomplex on Aerobic Exercise and Acute Recovery. Nutrients. 2023 Jan 13;15(2):421. doi: 10.3390/nu15020421.

  PMID: 36678293 RESULT

MeSH Terms

Conditions

Motor Activity; Inflammation

Interventions

Taste

Condition Hierarchy (Ancestors)

Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Justin D Roberts, Professor

  Anglia Ruskin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Nutritional supplement is provided in a double-blind manner. Both participants and research testers will be masked.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Phase 1: Participants are randomly assigned OliPhenolia or placebo (matched in taste and appearance) in a double blind manner. Following a ≥7 day wash out period, participants then cross-over to the alternate product. Phase 2: Following a further ≥7 day wash out period, participants will continue to consume the same product (OliPhenolia or placebo) for a further 16 days ahead of final exercise assessments.

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: June 6, 2025
• Study Start: July 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 10, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)