NCT06937190

Brief Summary

This study is a randomized, double-blind, placebo-controlled trial designed to examine the effects of pre-sleep creatine monohydrate supplementation on anaerobic performance and muscle damage markers in recreationally active females. Participants will be randomly assigned to receive either 5 grams of creatine monohydrate or a placebo 30 minutes before sleep for seven consecutive days. Anaerobic performance will be assessed using the Wingate Anaerobic Test, evaluating peak and average power output and fatigue index. Blood samples will be collected before and after the supplementation period to analyze markers of muscle damage, including creatine kinase and lactate dehydrogenase. This study aims to provide insight into the efficacy of short-term, time-specific creatine supplementation for enhancing performance and recovery.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2025

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 22, 2025

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2025

Completed
Last Updated

April 22, 2025

Status Verified

April 1, 2025

Enrollment Period

1 month

First QC Date

April 15, 2025

Last Update Submit

April 15, 2025

Conditions

Keywords

Creatine MonohydratePre-Sleep SupplementationAnaerobic PowerWingate TestMuscle Damage MarkersCreatine Kinase (CK)Lactate Dehydrogenase (LDH)Female Exercise PerformanceNutritional Ergogenic AidResistance TrainingRecovery Enhancement

Outcome Measures

Primary Outcomes (1)

  • Average Power Output (Watts) - 30-Second Wingate Test

    Average anaerobic power output will be calculated across the 30-second Wingate cycling test.

    Baseline and post-intervention (Day 0 and Day 7)

Secondary Outcomes (4)

  • Peak Power Output (Watts) - Wingate Test

    Baseline and post-intervention (Day 0 and Day 7)

  • Fatigue Index (%) - Wingate Test

    Baseline and post-intervention (Day 0 and Day 7)

  • Serum Creatine Kinase (CK) Activity

    Baseline and 24 hours post Wingate Test (Day 0 and Day 8)

  • Serum Lactate Dehydrogenase (LDH) Activity

    Baseline and 24 hours post Wingate Test (Day 0 and Day 8)

Study Arms (2)

Creatine Monohydrate Supplementation

EXPERIMENTAL

Participants will receive 5 grams of creatine monohydrate powder dissolved in water, flavored with a sugar-free agent, 30 minutes before sleep each night for 7 days.

Dietary Supplement: Creatine Monohydrate

Placebo Supplementation

PLACEBO COMPARATOR

Participants will receive 5 grams of a placebo powder (maltodextrin), visually identical and similarly flavored to the creatine supplement, 30 minutes before sleep each night for 7 days.

Dietary Supplement: Placebo (Maltodextrin)

Interventions

Creatine MonohydrateDIETARY_SUPPLEMENT

Participants will receive 5 grams of creatine monohydrate powder dissolved in water, flavored with a sugar-free agent, 30 minutes before sleep each night for 7 days.

Creatine Monohydrate Supplementation
Placebo (Maltodextrin)DIETARY_SUPPLEMENT

Visually identical placebo (maltodextrin powder, 5 g/day), flavored with a sugar-free agent, dissolved in water and consumed 30 minutes before sleep for 7 consecutive days.

Placebo Supplementation

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female, aged 18 to 25 years
  • Recreationally active (engaging in structured resistance training 3-4 times per week for the past 6 months)
  • Regular menstrual cycles (used for scheduling purposes)
  • Able and willing to provide informed consent
  • Agreement to maintain normal diet and training routines throughout the study

You may not qualify if:

  • History of musculoskeletal injury affecting lower or upper limbs within the past 6 months
  • Known allergy or intolerance to creatine or maltodextrin
  • Use of performance-enhancing substances or supplements within the last 30 days
  • Use of recovery modalities such as massage, cryotherapy, or compression garments during the study period
  • Current use of anti-inflammatory medication
  • Pregnancy or breastfeeding
  • Inability to comply with study protocol or scheduled assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Islamic Azad University, Shabestar Branch

Shabestar, East Azerbaijan Province, 5381637183, Iran

RECRUITING

MeSH Terms

Interventions

Creatinemaltodextrin

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Central Study Contacts

Morteza Jourkesh, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Neither the participants nor the investigators know which intervention the participant is receiving.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomly assigned to one of two groups: a creatine supplementation group or a placebo group, and they remain in that group for the duration of the trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asisstant Professor

Study Record Dates

First Submitted

April 15, 2025

First Posted

April 22, 2025

Study Start

April 1, 2025

Primary Completion

May 10, 2025

Study Completion

July 10, 2025

Last Updated

April 22, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

The individual participant data (IPD) will not be shared due to privacy concerns and the limited scope of this study. The study involves a small sample size, and data sharing could risk participant confidentiality. Additionally, there are currently no external collaborations or repositories arranged for data sharing.

Locations