The Effects of a Multicomponent Sleep & Recovery Supplement on Muscle Fatigue and Sleep

August 5, 2026 updated by: 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:

  1. Does the supplement reduce delayed onset muscle soreness (DOMS) following an intense exercise protocol?
  2. 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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Magnesium-based sleep & recovery supplementation
Supplementation of a magnesium-based sleep & recovery supplement (2g/day for 2-weeks)
Dietary supplement: magnesium-based sleep & recovery supplement
magnesium-based sleep & recovery supplement (2g/day for 2-weeks)
Placebo Comparator: Placebo Supplementation
Supplementation of placebo (2g/day for 2-weeks)
Dietary supplement: Placebo Supplementation
Placebo Supplementation (2g/day for 2-weeks)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Exeter

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 8096200

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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