- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tom G Gurney, PhD
- Phone Number: +44 (0) 1326 370400
- Email: t.g.gurney@exeter.ac.uk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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)
|
|
Placebo Comparator: Placebo Supplementation
Supplementation of placebo (2g/day for 2-weeks)
|
Placebo Supplementation (2g/day for 2-weeks)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in total work done
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in sleep quality
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 8096200
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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