NCT07210099

Brief Summary

There is current research interest in the use of fruit and plant-based food products containing high levels of natural antioxidants and their impact on exercise, which may be particularly beneficial for recreationally or low-active populations. One such product is an olive extract drink (called OliPhenolia®) produced by Fattoria La Vialla (an organic farm based in Northern Italy) and commercially available for the general public. Whilst previous research from the investigators (at Anglia Ruskin University) using this product has demonstrated potential antioxidant benefits and reduced oxygen cost during aerobic exercise, there are to date no studies investigating whether the short-term consumption of OliPhenolia® can benefit fat oxidation during exercise or whether such effects can be further enhanced employing a pre workout caffeinated beverage. Therefore the aim of this study is two-fold: i) to assess the impact of short-term supplementation (8 days) of OliPhenolia® relative to body mass on fat oxidation during aerobic cycling exercise in comparison to placebo in healthy recreationally active volunteers; and ii) whether potential benefits of OliPhenolia® on fat oxidation are enhanced with a pre-workout caffeinated beverage in comparison to placebo in healthy recreationally active volunteers.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
5mo left

Started May 2025

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress70%
May 2025Sep 2026

Study Start

First participant enrolled

May 30, 2025

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 7, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

June 3, 2025

Last Update Submit

March 26, 2026

Conditions

Keywords

FatMaxFat OxidationPolyphenolsCaffeine

Outcome Measures

Primary Outcomes (1)

  • Maximal fat oxidation (g/min)

    Assessment of total fat oxidation from stochiometrics (based on oxygen and carbon dioxide breath to breath measurements during exercise)

    Pre and post main intervention (8 days)

Secondary Outcomes (1)

  • Expired oxygen (L/min)

    Pre and post main intervention (8 days)

Study Arms (4)

OliPhenolia® plus placebo beverage

EXPERIMENTAL

OliPhenolia® is to be consumed twice daily, away from food and separated by ≥4 hours, for a period of 8 days. Note each serving of OliPhenolia® is a volume equivalent to ≤1.0mg∙kg-1 of Hydroxytyrosol. At the follow up test participants will also be provided with a 150mL placebo (microcrystalline cellulose at a dose of 6mg/kg) beverage pre-exercise.

Dietary Supplement: Concentrated olive fruit waterDietary Supplement: Placebo beverage

Placebo product plus placebo beverage

PLACEBO COMPARATOR

A taste and appearance matched placebo will be used within this research, conforming to the recipe utilised in previously published OliPhenolia® research. Recipe as follows; equal ratio \[1:1:1\] of prune juice, diet cola, and tonic water. The placebo formula will be provided in matched 28mL sterilised jars provided order to match OliPhenolia® original packaging. At the follow up test participants will also be provided with a 150mL placebo (microcrystalline cellulose at a dose of 6mg/kg) beverage pre-exercise.

Dietary Supplement: PlaceboDietary Supplement: Placebo beverage

OliPhenolia® +Caffeine (pre workout)

EXPERIMENTAL

OliPhenolia® is to be consumed twice daily, away from food and separated by ≥4 hours, for a period of 8 days. Note each serving of OliPhenolia® is a volume equivalent to ≤1.0mg∙kg-1 of Hydroxytyrosol. For the pre workout beverage this will be a single serve drink (150mL) containing flavoured water with 6mg/kg anhydrous caffeine based on previous research. The product will only be used pre-exercise as a single bolus.

Dietary Supplement: Concentrated olive fruit waterDietary Supplement: Anhydrous caffeine

Placebo +Caffeine (pre workout)

ACTIVE COMPARATOR

A taste and appearance matched placebo will be used within this research, conforming to the recipe utilised in previously published OliPhenolia® research. Recipe as follows; equal ratio \[1:1:1\] of prune juice, diet cola, and tonic water. The placebo formula will be provided in matched 28mL sterilised jars provided order to match OliPhenolia® original packaging. For the pre workout beverage this will be a single serve drink (150mL) containing flavoured water with 6mg/kg anhydrous caffeine based on previous research. The product will only be used pre-exercise as a single bolus.

Dietary Supplement: PlaceboDietary Supplement: Anhydrous caffeine

Interventions

PlaceboDIETARY_SUPPLEMENT

Placebo matched for taste and appearance consumed twice daily for eight days in the equivalent volume to the experimental product.

Placebo +Caffeine (pre workout)Placebo product plus placebo beverage
Anhydrous caffeineDIETARY_SUPPLEMENT

A single bolus of flavoured water (150mL) containing 6mg/kg anhydrous caffeine taken as a pre-exercise beverage

OliPhenolia® +Caffeine (pre workout)Placebo +Caffeine (pre workout)
Placebo beverageDIETARY_SUPPLEMENT

A single bolus of flavoured water (150mL) containing 6mg/kg microcrystalline cellulose

OliPhenolia® plus placebo beveragePlacebo product plus placebo beverage

Supplementation of OliPhenolia twice daily for eight days. Dose equivalent to ≤1.0mg∙kg-1 of hydroxytyrosol.

Also known as: OliPhenolia
OliPhenolia® +Caffeine (pre workout)OliPhenolia® plus placebo beverage

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women, UK based, above 21 years of age with a body mass index (BMI) \>18 and \<30 kg·m2 determined during baseline testing
  • Considered to be recreationally active i.e. approximately 150mins of general physical activity/ exercise per week (meeting the WHO physical activity guidelines); and a VO2peak (fitness) score \>20 and \<50 mL·kg-1·min-1 determined during baseline testing.
  • No known history (including family history) of heart abnormalities, hypertension, coronary heart disease or diabetes (determined from pre-study health screen questionnaire).
  • Not currently suffering from any musculoskeletal injury, or any other reason that may prevent participation in cardiovascular exercise.
  • Have not suffered from recent viral infections ie: influenza (defined within the prior 2 months).
  • Not taking any prescribed or over-the-counter medication which may influence exercise training (with the exception of inhalers for exercise induced asthma or contraceptive pill).
  • Not consuming or prepared to refrain from consumption, any commercial supplementation which conflicts with the study parameters ie: antioxidants.
  • No known allergy or intolerance to olives or prune/grape juice, or any known side effects from caffeine ingestion.

You may not qualify if:

  • If any of the above criteria is not met.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Cambridge, CB1 1PT, United Kingdom

RECRUITING

Study Officials

  • Justin D Roberts, Professor

    Anglia Ruskin University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Justin D Roberts, Professor

CONTACT

Joseph B Lillis

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Supplements (product, placebo and product and product + caffeine) will be provided in a randomized, double-blinded manner. Both the participants and research testers will be masked from knowing the specifics of the supplement intervention.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Participants will be randomly assigned to one of the 2 main experimental groups in a double-blinded manner. Following completion of the first round of testing, those participants consuming OliPhenolia will return after a 1 week wash out period and repeat the process but taking placebo, and vice versa. Therefore all participants will have consumed either test product or placebo. For the pre-follow up test beverage, participants will be randomly assigned to either placebo or caffeine in block manner. This exploratory study will only involve a single cross over.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 3, 2025

First Posted

October 7, 2025

Study Start

May 30, 2025

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations