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Not yet recruiting NCT07729072

The Effect of Olive Leaf Extract Supplementation on Training-induced Skeletal Muscle Functional and Molecular Adaptations in Healthy Volunteers

No phase Interventional Healthy Adult Participants Exercise Training Neuromuscular Adaptations Nutritional Intervention

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: Olive leaf extract, Placebo.
Who it may be relevant to
Registry conditions: Healthy Adult Participants, Exercise Training, Neuromuscular Adaptations, Nutritional Intervention. Basic parameters: 18 years — 45 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
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The goal of this study is to investigate the effect of combining olive leaf extract supplementation with endurance training (moderate intensity continuous training or sprint interval training). We hypothesize that OLE supplementation during training, as compared to training alone with placebo, will translate into better performance outcomes. More specifically, we hypothesize that the additional benefits of OLE supplementation on performance will be mediated by improved mitochondrial characteristics in skeletal muscle and increased neural activation.

Detailed description

Maximal exercise capacity (VO2peak) predicts cardiovascular risk and all-cause mortality. Regular moderate to vigorous physical activity, a key determinant of VO2peak, is essential for an optimal health status of the general population. Thus, strategies that accentuate the health benefits of exercise may have considerable therapeutic benefits. Skeletal muscle Ca2+ handling is a primary determinant of exercise capacity. The regulation of skeletal muscle contraction by Ca2+ is coupled to mitochondrial energy production through a mechanism involving transport across the inner mitochondrial membrane by the mitochondrial Ca2+ uniporter (MCU). Ca2+ entry in the mitochondrial matrix controls Ca2+ -sensitive enzymes, including pyruvate dehydrogenase (PDH) activity, a rate-limiting enzyme for glycolysis. Olive leaf extract (OLE) contains \~40% of the natural polyphenol oleuropein and is a potent activator of MCU in skeletal muscle with anti-inflammatory and antioxidant properties. The present study will be a double-blind, randomized, placebo-controlled, parallel study in healthy young individuals (18-45 years) consisting of a 3-week endurance training (either moderate intensity continuous training or sprint interval training) period combined with OLE or placebo intake. We will examine the impact of OLE supplementation on maximal exercise capacity, knee extensor neuromuscular function, muscular and blood adaptations. The results of this study will elucidate whether OLE supplementation improves fitness parameters and the molecular mechanisms regulating these adaptations.

Interventions

  • Dietary supplement Olive leaf extract
    A capsule containing 250 mg of an olive leaf extract preparation will be swallowed with a glass of water daily for 21 days.
  • Dietary supplement Placebo
    A capsule containing 336 mg of cellulose microcrystalline will be swallowed with a glass of water daily for 21 days.

Primary outcome measures

  • maximal aerobic power [Time frame: before and after the three-week training period]
Secondary outcome measures (3)
  • Maximal oxygen uptake [Time frame: before and after the three-week training period]
  • Submaximal heart rate and power [Time frame: before and after the three-week training period]
  • Knee extensor neuromuscular function [Time frame: before and after the three-week training period]

Eligibility criteria

Inclusion criteria

  • Being between 18 and 45 years old
  • Being healthy (assessed through the PAR-Q questionnaire).
  • Being physically active, but not involved in any structured training program
  • Being available for the study period.

Exclusion criteria

  • If a participant answers positively to any YES/NO question in the PAR-Q health questionnaire. For questions requiring a precision, any positive answer will be reviewed by a medical doctor, who will determine the inclusion/exclusion of the participant.
  • Having allergy to xylocaine
  • Being pregnant.

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
Parallel assignment
Masking
Triple blind
Primary purpose
Basic science

Study locations

Switzerland · 1 center
  • Bâtiment Synathlon, quartier UNIL-Centre — Lausanne

Publications

  • Gherardi G, Weiser A, Bermont F, Migliavacca E, Brinon B, Jacot GE, Hermant A, Sturlese M, Nogara L, Vascon F, De Mario A, Mattarei A, Garratt E, Burton M, Lillycrop K, Godfrey KM, Cendron L, Barron D, Moro S, Blaauw B, Rizzuto R, Feige JN, Mammucari C, De Marchi U. Mitochondrial calcium uptake declines during aging and is directly activated by oleuropein to boost energy metabolism and skeletal mu PMID 39603237
  • Zanou N, Dridi H, Reiken S, Imamura de Lima T, Donnelly C, De Marchi U, Ferrini M, Vidal J, Sittenfeld L, Feige JN, Garcia-Roves PM, Lopez-Mejia IC, Marks AR, Auwerx J, Kayser B, Place N. Acute RyR1 Ca2+ leak enhances NADH-linked mitochondrial respiratory capacity. Nat Commun. 2021 Dec 10;12(1):7219. doi: 10.1038/s41467-021-27422-1. PMID 34893614
  • Lanfranchi C, Moreno-Asso A, Horstman AMH, Mistro S, Migliavacca E, Cominetti O, Stolte J, Metairon S, Hermant A, Pedersen AL, Dayon L, De Marchi U, Feige JN, Zanou N, Place N. Oleuropein-based olive leaf extract enhances muscle mitochondrial bioenergetics response to moderate - but not maximal - intensity exercise in humans. J Physiol. 2026 May;604(10):3802-3824. doi: 10.1113/JP290316. Epub 2026 PMID 41979147

Identifiers

NCT: NCT07729072 · 2026-00654

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗