- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07586839
Effect of a Nutritional Supplement on Muscle Recovery (RECOVER)
7 maggio 2026 aggiornato da: Marlou Dirks, Wageningen University
The Role of a Nutritional Formulation Containing Caprylic Acid and Omega 3 Fatty Acids in Promoting Skeletal Muscle Function Recovery to Damaging Exercise in Healthy, Young Volunteers
The aim is to develop a food supplement drink that supports muscle health by combining specific fatty acids, which can positively affect metabolic and inflammation processes that are important for muscle health.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Descrizione dettagliata
This study will assess the effects of a vegan nutritional formulation containing caprylic acid and omega-3 fatty acids on recovery from muscle-damaging exercise.
The goal is to determine whether this supplement can mitigate muscle damage, reduce inflammation, and accelerate functional recovery, thereby supporting long-term muscle health and functional independence.
This research has the potential to reveal a novel approach to muscle health management, contributing to the development of safe and effective nutritional strategies that support healthy aging.
Tipo di studio
Interventistico
Iscrizione (Stimato)
28
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Silvie Timmers, PhD
- Numero di telefono: +31 317-484 136
- Email: silvie.timmers@wur.nl
Luoghi di studio
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Gelderland
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Wageningen, Gelderland, Olanda, 6708WD
- Reclutamento
- Wageningen University and Research
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Contatto:
- Human and Animal Physiology
- Numero di telefono: +31317484136
- Email: office.hap@wur.nl
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Sì
Descrizione
Inclusion Criteria:
- Young (≥18 and ≤35 years)
- Male sex
- Non-obese (≥18.5 and ≤27.5 kg/m2)
- Recreationally active (performing non-competitive exercise at least one time a week for minimally 30 minutes)
Exclusion Criteria:
- Smoking
- Participation in structural exercise with a major eccentric component (e.g. soccer, basketball, trail running, etc…)
- Chronic use of any prescribed over the counter pharmaceuticals
- Any history of medical or surgical events that may effect the study outcomes
- Following a specific diet (e.g. weight loss, ketogenic, vegan)
- Taking protein supplements
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Testdrink
Drink containing caprylic acid and omega-3 fatty acids
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Seven day supplementation with a muscle damaging exercise performed on day four
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Comparatore placebo: Control drink
Control drink that differs in fatty acid composition
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Seven day supplementation with a muscle damaging exercise performed on day four
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in isometric muscle strength of the vastus lateralis muscle on a muscle dynamometer before and 72h after damaging exercise
Lasso di tempo: The change in muscle strength will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
|
The main study endpoint is the change in skeletal muscle function recovery from a single bout of damaging eccentric exercise between an emulsion containing caprylic acid and omega 3 fatty acids, compared to a control emulsion, from before exercise (t=0) to 72 hours post-exercise.
Skeletal muscle function will be measured as maximal voluntary isometric muscle strength of the vastus lateralis muscle on a muscle dynamometer.
The maximal voluntary strength is expressed as maximal voluntary contraction (Newtons).
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The change in muscle strength will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in muscle fatigue from before until 72 hours after damaging exercise measured with electrical stimulation on a muscle dynamometer
Lasso di tempo: The change in fatigue resistance will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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The change in muscle fatigue recovery from a single bout of damaging eccentric exercise between an emulsion containing caprylic acid and omega 3 fatty acids compared to a control emulsion will be examined by means of a two-minute fatigue inducing protocol on a skeletal muscle dynamometer.
Every other second during two minutes, electrically induced muscle contractions will be evoked on the vastus lateralis muscle at 40% of the maximal voluntary muscle strength.
The percental decline in muscle force (N) generating capacity will be monitored as indicator of fatigue resistance.
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The change in fatigue resistance will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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Change in muscle soreness from before until up to 72 hours after a damaging exercise using a VAS-Scale and soreness questionnaire
Lasso di tempo: The change in muscle soreness will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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The change in muscle soreness from a single bout of eccentric exercise between an emulsion containing caprylic acid and omega 3 fatty acids, compared to a control emulsion will be measured by means of a VAS-Scale, measuring current muscle soreness, as well as a retrospective pain questionnaire, measuring muscle soreness over the preceding 24 hours.
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The change in muscle soreness will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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Plasma creatine kinase concentrations before and up to 72 hours after damaging exercise in blood
Lasso di tempo: The change in plasma creatine kinase will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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The change in creatine kinase concentrations from a single bout of eccentric exercise between an emulsion containing caprylic acid and omega 3 fatty acids, compared to a control emulsion, will be measured using commercially available kits.
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The change in plasma creatine kinase will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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Plasma cholesterol concentrations before and up to 72 hours after damaging exercise in blood
Lasso di tempo: The change in plasma cholesterol concentrations will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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The change in plasma cholesterol concentrations from a single bout of eccentric exercise between an emulsion containing caprylic acid and omega 3 fatty acids, compared to a control emulsion, will be measured using commercially available kits
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The change in plasma cholesterol concentrations will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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Plasma triglyceride concentrations before and up to 72 hours after damaging exercise in blood
Lasso di tempo: The change in plasma triglycerides will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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The change in plasma triglyceride concentrations from a single bout of eccentric exercise between an emulsion containing caprylic acid and omega 3 fatty acids, compared to a control emulsion, will be measured using commercially available kits.
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The change in plasma triglycerides will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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Plasma beta-hydroxybutyrate concentrations before and up to 72 hours after damaging exercise in blood
Lasso di tempo: The change in plasma beta-hydroxybutyrate will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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The change in plasma beta-hydroxybutyrate concentrations from a single bout of eccentric exercise between an emulsion containing caprylic acid and omega 3 fatty acids, compared to a control emulsion, will be measured using commercially available kits.
|
The change in plasma beta-hydroxybutyrate will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
26 settembre 2025
Completamento primario (Stimato)
1 giugno 2026
Completamento dello studio (Stimato)
1 settembre 2026
Date di iscrizione allo studio
Primo inviato
21 febbraio 2025
Primo inviato che soddisfa i criteri di controllo qualità
7 maggio 2026
Primo Inserito (Effettivo)
14 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
14 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
7 maggio 2026
Ultimo verificato
1 aprile 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- NL88300.028.24
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .