NCT06604793

Brief Summary

The purpose is to compare the effects of bolus ingestion (5 grams) vs. intermittent ingestion (2 x 2.5 grams) of creatine supplementation vs. placebo for 21 days on measures of body composition (lean tissue mass-indicator of muscle mass, total body water) and muscle performance (i.e., power, strength, endurance).

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

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

August 20, 2024

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

September 20, 2024

Status Verified

September 1, 2024

Enrollment Period

5 months

First QC Date

September 17, 2024

Last Update Submit

September 17, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • Whole-body lean mass (kg)

    Bioelectrical impedance analysis

    baseline, day 21

  • Strength

    1-repetition maximum leg press and chest press (kg)

    baseline, day 21

  • Endurance

    Repetitions to fatigue for leg press and chest press (total number)

    baseline, day 21

  • Hydration

    Total body water (kg) using bioelectrical impedance analysis

    baseline, day 21

  • Power

    Vertical Jump (cm)

    baseline, day 21

  • Power

    Medicine Ball Throw (feet)

    baseline, day 21

Study Arms (3)

Creatine Bolus

EXPERIMENTAL

(Serving 1: 5 grams of creatine monohydrate + 3 grams of placebo in the morning; Serving 2: 8 grams of placebo in the evening) for 21 days.

Dietary Supplement: Creatine

Creatine Intermittent

EXPERIMENTAL

(Serving 1: 2.5 grams of creatine monohydrate + 5.5 grams of placebo in the morning; Serving 2: 2.5 grams of creatine monohydrate + 5.5 grams of placebo in the evening) for 21 days.

Dietary Supplement: Creatine

Placebo

PLACEBO COMPARATOR

(Servings 1: 8 grams of placebo in the morning; Serving 2: 8 grams of placebo in the evening) for 21 days.

Dietary Supplement: Placebo

Interventions

CreatineDIETARY_SUPPLEMENT

Creatine monohydrate

Creatine BolusCreatine Intermittent
PlaceboDIETARY_SUPPLEMENT

Maltodextrin

Placebo

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • if you are 18-39 years of age
  • if you have not been performing resistance training for at least 4 weeks prior to the start of the study.

You may not qualify if:

  • if you are pregnant or nursing
  • have taken creatine monohydrate within 30 days prior to the start of the study
  • if you have pre-existing allergies to the placebo (corn-starch maltodextrin)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Regina

Regina, Saskatchewan, S4S 0A2, Canada

RECRUITING

MeSH Terms

Interventions

Creatine

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Darren Candow

    University of Regina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 17, 2024

First Posted

September 20, 2024

Study Start

August 20, 2024

Primary Completion

January 31, 2025

Study Completion

January 31, 2025

Last Updated

September 20, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations