- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07586839
Effect of a Nutritional Supplement on Muscle Recovery (RECOVER)
7 mei 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Conditie
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
28
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Silvie Timmers, PhD
- Telefoonnummer: +31 317-484 136
- E-mail: silvie.timmers@wur.nl
Studie Locaties
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-
Gelderland
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Wageningen, Gelderland, Nederland, 6708WD
- Werving
- Wageningen University and Research
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Contact:
- Human and Animal Physiology
- Telefoonnummer: +31317484136
- E-mail: office.hap@wur.nl
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Ja
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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
|
|
Placebo-vergelijker: Control drink
Control drink that differs in fatty acid composition
|
Seven day supplementation with a muscle damaging exercise performed on day four
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in isometric muscle strength of the vastus lateralis muscle on a muscle dynamometer before and 72h after damaging exercise
Tijdsspanne: 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).
|
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.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in muscle fatigue from before until 72 hours after damaging exercise measured with electrical stimulation on a muscle dynamometer
Tijdsspanne: 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.
|
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.
|
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.
|
|
Change in muscle soreness from before until up to 72 hours after a damaging exercise using a VAS-Scale and soreness questionnaire
Tijdsspanne: 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.
|
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.
|
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.
|
|
Plasma creatine kinase concentrations before and up to 72 hours after damaging exercise in blood
Tijdsspanne: 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.
|
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.
|
|
Plasma cholesterol concentrations before and up to 72 hours after damaging exercise in blood
Tijdsspanne: 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.
|
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
|
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.
|
|
Plasma triglyceride concentrations before and up to 72 hours after damaging exercise in blood
Tijdsspanne: 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.
|
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
Tijdsspanne: 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.
|
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.
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
26 september 2025
Primaire voltooiing (Geschat)
1 juni 2026
Studie voltooiing (Geschat)
1 september 2026
Studieregistratiedata
Eerst ingediend
21 februari 2025
Eerst ingediend dat voldeed aan de QC-criteria
7 mei 2026
Eerst geplaatst (Werkelijk)
14 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
14 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
7 mei 2026
Laatst geverifieerd
1 april 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- NL88300.028.24
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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