Идёт набор NCT07210099

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

Без фазы С лечением Healthy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Concentrated olive fruit water, Placebo, Anhydrous caffeine, Placebo beverage.
Кому может быть актуально: Состояния в реестре: Healthy. Базовые параметры: от 21 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Великобритания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

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

Первичные конечные точки

Maximal fat oxidation (g/min) [Срок оценки: Pre and post main intervention (8 days)]

Вторичные конечные точки (1)

Expired oxygen (L/min) [Срок оценки: Pre and post main intervention (8 days)]

Критерии участия

Критерии включения

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.