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

Anglia Ruskin University

Status: Enrolling

Conditions: Healthy

Treatments: Dietary Supplement: Anhydrous caffeine; Dietary Supplement: Concentrated olive fruit water; Dietary Supplement: Placebo; Dietary Supplement: Placebo beverage

Study type: Interventional

Funder types: Other

Identifiers

NCT07210099

ETH2425-5668

Details and patient eligibility

About

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.

Full 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).

Enrollment: 40 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 4 patient groups, including a placebo group

OliPhenolia® plus placebo beverage

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Placebo beverage

Dietary Supplement: Concentrated olive fruit water

Placebo product plus placebo beverage

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo beverage

Dietary Supplement: Placebo

OliPhenolia® +Caffeine (pre workout)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Concentrated olive fruit water

Dietary Supplement: Anhydrous caffeine

Placebo +Caffeine (pre workout)

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Anhydrous caffeine