NCT07756164

Brief Summary

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:

  • 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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Aug 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Aug 2026Dec 2026

First Submitted

Initial submission to the registry

April 16, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 10, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

August 10, 2026

Status Verified

August 1, 2026

Enrollment Period

2 months

First QC Date

April 16, 2026

Last Update Submit

August 5, 2026

Conditions

Keywords

Muscle DamageSleepSupplementationRecovery

Outcome Measures

Primary Outcomes (5)

  • Changes in total work done

    Changes in total work done as measured by the Biodex

    Following each 2-week supplementation period of either supplement

  • Changes in work done (Flexion)

    Changes in work done (Flexion) as measured by the Biodex

    Following each 2-week supplementation period of either supplement

  • Changes in work done (Extension)

    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

    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

    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 Outcomes (6)

  • Changes in sleep quality

    Following each 2-week supplementation period of either supplement.

  • Changes in perceived muscle soreness (Pain pressure threshold)

    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)

    Following each 2-week supplementation period of either supplement and 24hr and 48hr following the muscle damaging protocol

  • Changes in Sleep Quality

    Following each 2-week supplementation period of either supplement.

  • Change in perceived recovery status (10-Point Likert Scale)

    Following each 2-week supplementation period of either supplement and 24hr and 48hr following the muscle damaging protocol

  • +1 more secondary outcomes

Study Arms (2)

Magnesium-based sleep & recovery supplementation

EXPERIMENTAL

Supplementation of a magnesium-based sleep \& recovery supplement (2g/day for 2-weeks)

Dietary Supplement: magnesium-based sleep & recovery supplement

Placebo Supplementation

PLACEBO COMPARATOR

Supplementation of placebo (2g/day for 2-weeks)

Dietary Supplement: Placebo Supplementation

Interventions

magnesium-based sleep \& recovery supplement (2g/day for 2-weeks)

Magnesium-based sleep & recovery supplementation
Placebo SupplementationDIETARY_SUPPLEMENT

Placebo Supplementation (2g/day for 2-weeks)

Placebo Supplementation

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged between 18-40, healthy and non smokers
  • Recreationally active, exercise at least 2 times a week

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2026

First Posted

August 10, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

August 10, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF