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Completed

NCT Number: NCT07008586

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.

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Key information

Conditions

Healthy Behavior Inflammation Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Cambridge, CB5 8DZ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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 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).

Primary outcomes

  1. Interleukin 6

    Time frame: Four days

  2. Interleukin 1 receptor antagonist

    Time frame: Four days

  3. Transforming growth factor-beta

    Time frame: Four days

  4. Lactate dehydrogenase

    Time frame: Four days

  5. Superoxide dismutase

    Time frame: Four days

Secondary outcomes

  1. Functional movement screen

    Time frame: Four days

    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.

  2. Counter movement jump

    Time frame: Four days

    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.

  3. Physical Readiness Questionnaire

    Time frame: Four days

    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.

  4. Perceived Muscle soreness

    Time frame: Four days

    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.

  5. Pain questionnaire

    Time frame: Four days

    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.

  6. Algometry

    Time frame: Four days

    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).

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

    Time frame: Four days

    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.

  8. Cognitive Function

    Time frame: Four days

    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.

  9. Heart Rate Variability

    Time frame: Four days

    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.

Sponsors and collaborators

Lead sponsor

Anglia Ruskin University

Other

Collaborators

  • Fattoria La Vialla di Gianni, Antonio e Bandino Lo Franco Soc. Agr. Sempl.

Registry information

Official study title

The Acute and Chronic Effects of OliPhenolia® Supplementation on Exercise Induced Inflammation and Functional Movement in Healthy Adult Humans.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 6, 2025
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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