The Effects of a Multicomponent Sleep & Recovery Supplement on Muscle Fatigue and Sleep
5 de agosto de 2026 atualizado por: University of Exeter
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
Visão geral do estudo
Status
Ainda não está recrutando
Tipo de estudo
Intervencional
Inscrição (Estimado)
25
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Tom G Gurney, PhD
- Número de telefone: +44 (0) 1326 370400
- E-mail: t.g.gurney@exeter.ac.uk
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Sim
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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)
|
|
Comparador de Placebo: Placebo Supplementation
Supplementation of placebo (2g/day for 2-weeks)
|
Placebo Supplementation (2g/day for 2-weeks)
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Changes in total work done
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Changes in sleep quality
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de agosto de 2026
Conclusão Primária (Estimado)
1 de outubro de 2026
Conclusão do estudo (Estimado)
1 de dezembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
16 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
5 de agosto de 2026
Primeira postagem (Real)
10 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
10 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
5 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 8096200
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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