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Recruiting NCT07210099

The Effect of Short-term Supplementation of OliPhenolia® on Fat Oxidation

No phase Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Concentrated olive fruit water, Placebo, Anhydrous caffeine, Placebo beverage.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effect of Short-term Supplementation of OliPhenolia® on Fat Oxidation in Recreationally Active Volunteers

Overview

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.

Detailed description

This exploratory study will involve initial recruitment of approximately 30-40 healthy volunteers to undertake an initial study briefing pre-screening health questionnaire, informed written consent and familiarisation to exercise equipment, before returning to the human physiology laboratory at Anglia Ruskin University on a separate occasion (Visit 1) to undertake a standard exercise test for maximal fitness capacity.

Following this, Visit 2 will see participants undertake a standard fat oxidation exercise test (aerobic exercise on a cycle ergometer) to ascertain maximal fat oxidation (Fatmax) with increasing exercise intensity, as well as a steady state exercise bout (30mins at FATmax).

After this participants will begin a short-term (8 days) supplementation period of either OliPhenolia or Placebo before returning for a follow up fat oxidation assessment (Visit 3) as above. Fat oxidation will be assessed by standard respiratory measures (breath to breath for oxygen and carbon dioxide). On the follow up test (Visit 3), a pre-exercise workout drink will be provided containing either caffeine flavoured water or placebo. This is to assess whether fat oxidation can be enhanced from short-term polyphenol supplementation (OliPhenolia) with or without additional caffeine prior to exercise.

Participants will therefore be randomised into 1 of 4 groups for this study (Placebo product for 8 days + placebo beverage at follow up; Oliphenolia for 8 days + placebo beverage at follow up; and OliPhenolia for 8 days plus caffeinated beverage at follow up; and placebo product for 8 days plus caffeinated beverage at follow up).

Interventions

  • Dietary supplement Concentrated olive fruit water
    Supplementation of OliPhenolia twice daily for eight days. Dose equivalent to ≤1.0mg∙kg-1 of hydroxytyrosol.
  • Dietary supplement Placebo
    Placebo matched for taste and appearance consumed twice daily for eight days in the equivalent volume to the experimental product.
  • Dietary supplement Anhydrous caffeine
    A single bolus of flavoured water (150mL) containing 6mg/kg anhydrous caffeine taken as a pre-exercise beverage
  • Dietary supplement Placebo beverage
    A single bolus of flavoured water (150mL) containing 6mg/kg microcrystalline cellulose

Primary outcome measures

  • Maximal fat oxidation (g/min) [Time frame: Pre and post main intervention (8 days)]
Secondary outcome measures (1)
  • Expired oxygen (L/min) [Time frame: Pre and post main intervention (8 days)]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • If any of the above criteria is not met.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Basic science

Study locations

United Kingdom · 1 center
  • Cambridge Centre for Sport and Exercise Sciences, Anglia Ruskin University, — Cambridge

Identifiers

NCT: NCT07210099 · ETH2425-5668

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗