Clinical trial NCT07008586: The Impact of OliPhenolia® Supplementation on Exercise Induced Inflammation and Functional Movement in Humans.
Official title: The Acute and Chronic Effects of OliPhenolia® Supplementation on Exercise Induced Inflammation and Functional Movement in Healthy Adult Humans.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Hydroxytyrosol
Exercise
Inflammation
Mobility
Lead sponsor: Anglia Ruskin University
Sponsor class: OTHER
Collaborators: name: Fattoria La Vialla di Gianni, Antonio e Bandino Lo Franco Soc. Agr. Sempl.
First posted: 2025-06-06
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: BASIC_SCIENCE

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. 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Interleukin 6
timeFrame: Four days
measure: Interleukin 1 receptor antagonist
timeFrame: Four days
measure: Transforming growth factor-beta
timeFrame: Four days
measure: Lactate dehydrogenase
timeFrame: Four days
measure: Superoxide dismutase
timeFrame: Four days
Secondary outcomes:
measure: Functional movement screen
timeFrame: Four days
measure: Counter movement jump
timeFrame: Four days
measure: Physical Readiness Questionnaire
timeFrame: Four days
measure: Perceived Muscle soreness
timeFrame: Four days
measure: Pain questionnaire
timeFrame: Four days
measure: Algometry
timeFrame: Four days
measure: Range of motion at the knee and hip joint (Goiniometry)
timeFrame: Four days
measure: Cognitive Function
timeFrame: Four days
measure: Heart Rate Variability
timeFrame: Four days
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge Centre for Sport and Exercise Sciences, Anglia Ruskin University,
Study officials:
affiliation: Anglia Ruskin University
name: Justin D Roberts, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.