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HealthyNCT07008586

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

A study testing OliPhenolia® in people with Healthy, run by Anglia Ruskin University at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
OliPhenolia®
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
1 siteUnited Kingdom
Study dates
1 Jul 2025to 10 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Cambridge Centre for Sport and Exercise Sciences, Anglia Ruskin University,

    Cambridge, CB5 8DZ

Other trials in United Kingdom

About this study

Official title: The Acute and Chronic Effects of OliPhenolia® Supplementation on Exercise Induced Inflammation and Functional Movement in Healthy Adult 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:

Read more
  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.

Read the detailed description

Following the current scientific interest surrounding the application of polyphenols in an exercise domain, the primary objectives of this research will build upon previously published work investigating polyphenol rich olive fruit water by identifying the acute and chronic effect of OliPhenolia® on inflammation and functional mobility following exercise induced inflammation. For the purpose of this research, the impact on inflammation will be investigated via the measurements of biomarkers Interleukin (IL)-6, IL-1ra, and Transforming growth factor-beta. Additionally, lactate dehydrogenase (a marker of muscle damage) and superoxide dismutase (a marker of oxidative stress) will also be measured to confirm the source and impact of the exercise induced inflammation. Furthermore, for the purpose of this research, a functional movement screen, localised goniometry and algometry will be measured surrounding the standardised exercise protocol to assess the impact of OliPhenolia on functional mobility. Within this study, participants will be required to attend a pre-screening and familiarisation session followed by three separate trials. Each trial, separated by a ~7 day wash out period will consist of four visits. The first visit (estimated duration 3 hours) will include the baseline resting venepuncture blood sample (0), basic physiological, anthropometric and cognitive assessments, standardised exercise protocol, post exercise blood sample (+1 hour) and post exercise physiological assessment. The standardised exercise protocol that will take place 40 minutes after the supplementation of OliPhenolia is as follows: A maximum of six sets of 25 drop jumps wearing a weighted vest (7.5% body mass) from a height of 60 cm with a maximum 10 second interval between jumps and a 1 min passive rest between sets (modified from Kirby et al., 2011). The following three visits (estimated duration 45 minutes) will take place over the following three days and require a resting venepuncture blood sample (+24 hours, +48 hours and +72 hours) and basic physiological assessment only. Prior to each visit, participants will be required to record a three-day habitual food and exercise diary and adhere to a prescribed low polyphenol meal the night before each laboratory visit. These measures are in place to increase the control of the study.

Conditions
Healthy
Being tested
OliPhenolia®, Taste and appearance matched placebo
Keywords
Hydroxytyrosol, Exercise, Inflammation, Mobility
Medical subject headings
Motor Activity, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Taste and appearance matched placeboDietary 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).

Study groups in NCT07008586
Study groupRoleWhat they receive
OliPhenoliaExperimentalCommercially 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..
Receives: Dietary Supplement: OliPhenolia®
PlaceboPlacebo comparatorIn 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.
Receives: Dietary Supplement: Taste and appearance matched placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Interleukin 6

    Measured: Four days

  2. Interleukin 1 receptor antagonist

    Measured: Four days

  3. Transforming growth factor-beta

    Measured: Four days

  4. Lactate dehydrogenase

    Measured: Four days

  5. Superoxide dismutase

    Measured: Four days

Secondary outcomes (9)
  1. Functional movement screen

    The functional movement screen (FMS) will utilise the FMS test kit (Functional Movement Systems s Inc, USA) and comprise of seven movement screens described by the creators of the method: (1) "Deep squat"; (2) "Hurdle step"; (3) "In-line lunge"; (4) "Shoulder mobility"; (5) "Active straight-leg raise"; (6) "Trunk stability push-up"; And (7) "Rotary stability. This test will be utilised to correlate to day-today functional movements through the assessment of hamstring and lumbar flexibility, whole body range of motion, core strength and stability.

    Measured: Four days

  2. Counter movement jump

    To assess lower body mechanical capacity and neuromuscular fatigue. Each participant will be invited to complete three repetitions of the counter movement jump with the highest repetition being recorded as the result.

    Measured: Four days

  3. Physical Readiness Questionnaire

    Participants will complete the European Federation of Sports Medicine Association (EFSMA) Pre-Participation Evaluation (PPE) form for recreationally active athletes (2021) to evaluate physical readiness. Section three of this form will be repeated to subjectively measure musculoskeletal soreness surrounding the standardised exercise bout. It is important to mention, this document is merely a guideline and the 'Medical' 'Laboratory tests' and 'Exercise Capacity' sections of this document within section 3 will not be used.

    Measured: Four days

  4. Perceived Muscle soreness

    Perceived muscle soreness of the lower body will be assessed using a visual analogue scale surrounding the standardised exercise protocol. Participants will subjectively rate their level of soreness during a maximal contraction of their quadriceps group by drawing an intersecting line across a continuum line extending from 0 cm (0 = no soreness) to 13 cm (13 = extreme soreness) (Buford et al. 2009). The scale is a continuous line and does not contain any segments or labels that would allow for quantification by the participant, therefore not allowing the participant to retain any perceived soreness value between testing sessions.

    Measured: Four days

  5. Pain questionnaire

    The McGill Pain Questionnaire will be employed to offer a subjective measure of musculoskeletal pain. The questionnaire that provides a list of 78 descriptors of pain from which the user can pick words that can later be summed to yield a sensory, effective, and evaluative overall pain score.

    Measured: Four days

  6. Algometry

    Participants perception of muscle soreness will be assessed using a simple handheld algometer (Wagner Instruments) in the non-dominant quadricep (thigh muscle). This device has been used numerous times within research studies in our laboratory. Data will be collected surrounding the standardised exercise protocol. Muscle soreness will be assessed using a standard process employing both pressure tolerance (reporting the maximum amount of pressure generating perceived discomfort that is tolerable) and secondly, pressure threshold (the minimum amount of force applied until the first verbal report of discomfort) is observed).

    Measured: Four days

  7. Range of motion at the knee and hip joint (Goiniometry)

    In order to obtain an objective measure of joint angle and range of motion in the hip and knee joint, a manual goniometer will be employed. Data will be collected at baseline, after the standardised exercise protocol as well as the three days following.

    Measured: Four days

  8. Cognitive Function

    The Mini Mental State Examination (MMSE), or similar, will be used to systematically and thoroughly assess mental status. It is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. Assessments of cognition will take place at baseline, 24, 48 and 72 hours following the standardised exercise protocol.

    Measured: Four days

  9. Heart Rate Variability

    Heart Rate Variability will be measured using a heart rate monitor to provide an objective physiological measure that is linked to the cardiovascular (CV) system and CV health.

    Measured: Four days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2025
  2. Study start1 Jul 2025
  3. Primary completion30 Nov 2025
  4. Study completion10 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07008586
Sponsor's protocol ID
ETH2425-3172
Status last verified
Mar 2026
First submitted
19 May 2025
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36678293

Questions about this trial

What is this clinical trial studying?

A study testing OliPhenolia® in people with Healthy, run by Anglia Ruskin University at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Interleukin 6 (time frame: Four days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07008586, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

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