- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07586839
Effect of a Nutritional Supplement on Muscle Recovery (RECOVER)
7. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Intervensjonell
Registrering (Antatt)
28
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Silvie Timmers, PhD
- Telefonnummer: +31 317-484 136
- E-post: silvie.timmers@wur.nl
Studiesteder
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Gelderland
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Wageningen, Gelderland, Nederland, 6708WD
- Rekruttering
- Wageningen University and Research
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Ta kontakt med:
- Human and Animal Physiology
- Telefonnummer: +31317484136
- E-post: office.hap@wur.nl
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Ja
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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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Placebo komparator: Control drink
Control drink that differs in fatty acid composition
|
Seven day supplementation with a muscle damaging exercise performed on day four
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in isometric muscle strength of the vastus lateralis muscle on a muscle dynamometer before and 72h after damaging exercise
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in muscle fatigue from before until 72 hours after damaging exercise measured with electrical stimulation on a muscle dynamometer
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
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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.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
26. september 2025
Primær fullføring (Antatt)
1. juni 2026
Studiet fullført (Antatt)
1. september 2026
Datoer for studieregistrering
Først innsendt
21. februar 2025
Først innsendt som oppfylte QC-kriteriene
7. mai 2026
Først lagt ut (Faktiske)
14. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. mai 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NL88300.028.24
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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