- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Tom G Gurney, PhD
- Telefonní číslo: +44 (0) 1326 370400
- E-mail: t.g.gurney@exeter.ac.uk
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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)
|
|
Komparátor placeba: Placebo Supplementation
Supplementation of placebo (2g/day for 2-weeks)
|
Placebo Supplementation (2g/day for 2-weeks)
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Changes in total work done
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Changes in sleep quality
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 8096200
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .