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- Klinische proef NCT07756164
The Effects of a Multicomponent Sleep & Recovery Supplement on Muscle Fatigue and Sleep
The Effects of a Multicomponent Sleep & Recovery Supplement on Exercise Performance and Recovery Following a Muscle Damaging Protocol
The goal of this clinical trial (randomised crossover study) is to learn if a multi-component sleep and exercise recovery supplement can improve sleep quality and enhance recovery following exercise in healthy, recreationally active adults aged 18-40.
The main questions it aims to answer are:
- Does the supplement reduce delayed onset muscle soreness (DOMS) following an intense exercise protocol?
- Does the supplement improve sleep quality?
Researchers will compare the supplement to a placebo (a look-alike tablet with no active ingredients) to see if the supplement improves exercise recovery and sleep quality. In this crossover design, all participants will receive both the supplement and the placebo in separate 2-week periods, with a 2-week washout period in between.
Participants will:
- Take the supplement during one 2-week period and the placebo during another (order randomised), 30 minutes before bed each day
- Complete an exercise protocol involving repeated leg extensions designed to induce muscle fatigue
- Attend six laboratory visits, including baseline testing and follow-up assessments at 24 and 48 hours post-exercise
- Complete daily sleep questionnaires during each supplementation period
- Record food intake prior to exercise trials and replicate it for consistency
- Perform muscle soreness assessments and single-leg jump tests before and after exercise, and during recovery
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Tom G Gurney, PhD
- Telefoonnummer: +44 (0) 1326 370400
- E-mail: t.g.gurney@exeter.ac.uk
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Aged between 18-40, healthy and non smokers
- Recreationally active, exercise at least 2 times a week
Exclusion Criteria:
• Not have any injuries that would affect performance
- Not taking any medications that could affect drowsiness or energy levels
- Not taking any other dietary supplements high in magnesium
- Not be pregnant
- Not have any illness or medical condition that could make intense exercise unsafe
- Not be participating in other studies that could interfere with the outcomes of this study
- Not have any current sleep problems e.g. Insomnia
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Magnesium-based sleep & recovery supplementation
Supplementation of a magnesium-based sleep & recovery supplement (2g/day for 2-weeks)
|
magnesium-based sleep & recovery supplement (2g/day for 2-weeks)
|
|
Placebo-vergelijker: Placebo Supplementation
Supplementation of placebo (2g/day for 2-weeks)
|
Placebo Supplementation (2g/day for 2-weeks)
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Changes in total work done
Tijdsspanne: Following each 2-week supplementation period of either supplement
|
Changes in total work done as measured by the Biodex
|
Following each 2-week supplementation period of either supplement
|
|
Changes in work done (Flexion)
Tijdsspanne: Following each 2-week supplementation period of either supplement
|
Changes in work done (Flexion) as measured by the Biodex
|
Following each 2-week supplementation period of either supplement
|
|
Changes in work done (Extension)
Tijdsspanne: Following each 2-week supplementation period of either supplement
|
Changes in work done (Extension) as measured by the Biodex
|
Following each 2-week supplementation period of either supplement
|
|
Changes in Single Leg jump height
Tijdsspanne: Before and Immediately After Muscle Damaging Protocol at the End of Each 2-Week Supplementation Period
|
Changes in Single Leg jump height (m)
|
Before and Immediately After Muscle Damaging Protocol at the End of Each 2-Week Supplementation Period
|
|
Changes in Single Leg Jump hang time
Tijdsspanne: Before and Immediately After Muscle Damaging Protocol at the End of Each 2-Week Supplementation Period
|
Changes in Single Leg Jump hang time (s)
|
Before and Immediately After Muscle Damaging Protocol at the End of Each 2-Week Supplementation Period
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Changes in sleep quality
Tijdsspanne: Following each 2-week supplementation period of either supplement.
|
Changes in sleep quality as measured by the Groningen Sleep Quality questionnaire where a lower score indicates better sleep quality.
|
Following each 2-week supplementation period of either supplement.
|
|
Changes in perceived muscle soreness (Pain pressure threshold)
Tijdsspanne: Following each 2-week supplementation period of either supplement and 24hr and 48hr following the muscle damaging protocol.
|
Changes in perceived muscle soreness (Pain pressure threshold in Newtons) as measured by the muscle algometer where a higher score means a better outcome
|
Following each 2-week supplementation period of either supplement and 24hr and 48hr following the muscle damaging protocol.
|
|
Change in Self-Reported Readiness to Train Score (5-Point Likert Scale)
Tijdsspanne: Following each 2-week supplementation period of either supplement and 24hr and 48hr following the muscle damaging protocol
|
Change in perceived readiness to train or compete assessed using a self-reported 5-point Likert scale, where 1 = not at all ready (extremely fatigued/sore) and 5 = completely ready (fresh, no limitations)
|
Following each 2-week supplementation period of either supplement and 24hr and 48hr following the muscle damaging protocol
|
|
Changes in Sleep Quality
Tijdsspanne: Following each 2-week supplementation period of either supplement.
|
Changes in Sleep Quality as measured by the Consensus Sleep Diary.
|
Following each 2-week supplementation period of either supplement.
|
|
Change in perceived recovery status (10-Point Likert Scale)
Tijdsspanne: Following each 2-week supplementation period of either supplement and 24hr and 48hr following the muscle damaging protocol
|
Change in perceived readiness to train or compete assessed using a self-reported 10-point Likert scale, where 0 = very poorly recovered and 10 = fully recovered
|
Following each 2-week supplementation period of either supplement and 24hr and 48hr following the muscle damaging protocol
|
|
Change in perceived overall muscle soreness (10-Point Likert Scale)
Tijdsspanne: Following each 2-week supplementation period of either supplement and 24hr and 48hr following the muscle damaging protocol
|
Change in perceived readiness to train or compete assessed using a self-reported 10-point Likert scale, where 0 = no soreness and 10 = worse soreness imaginable
|
Following each 2-week supplementation period of either supplement and 24hr and 48hr following the muscle damaging protocol
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 8096200
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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