NCT06606704

Brief Summary

The primary purpose is to compare the effects of creatine supplementation (bolus ingestion of 5 grams vs. 3 grams) during 16 weeks of resistance-band training on measures of body composition (i.e., whole-body lean tissue mass, total body water), arm and leg muscle thickness (growth), muscle performance (i.e., power, strength, endurance) and functional ability (i.e., walking speed, balance). A secondary purpose of this research is to examine the effects of bolus ingestion of creatine (5 grams) compared to intermittent ingestion of creatine (2 x 2.5 grams) during 16 weeks of resistance-band training on measures of body composition (i.e., whole-body lean tissue mass, total body water), arm and leg muscle thickness (growth), muscle performance (i.e., power, strength, endurance) and functional ability (i.e., walking speed, balance).

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

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
27 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 23, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

September 23, 2024

Status Verified

September 1, 2024

Enrollment Period

11 months

First QC Date

September 16, 2024

Last Update Submit

September 18, 2024

Conditions

Keywords

AgingCreatineResistance-BandsMuscleStrength

Outcome Measures

Primary Outcomes (7)

  • Whole-body lean mass (kg)

    Bioelectrical impedance analysis

    baseline, week 16

  • Muscle Hypertrophy (cm)

    B-mode ultrasound

    baseline, week 16

  • Strength (kg)

    1-repetition maximum leg press and chest press

    baseline, week 16

  • Endurance (number of repetitions to fatigue)

    Leg press and chest press

    baseline, week 16

  • Power (feet)

    medicine ball throw

    baseline, week 16

  • Balance (Centre of Pressure)

    Force Plate

    baseline, week 16

  • Gait Speed (meters)

    Walking distance

    baseline, week 16

Study Arms (4)

Creatine Bolus 5

EXPERIMENTAL
Dietary Supplement: Creatine Bolus 5

Creatine Bolus 3

EXPERIMENTAL
Dietary Supplement: Creatine Bolus 3

Creatine Intermittent 5

EXPERIMENTAL
Dietary Supplement: Creatine Intermittent 5

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Creatine Bolus 5DIETARY_SUPPLEMENT

(Serving 1: 5 grams of creatine + 3 grams of placebo in the morning; Serving 2: 8 grams of placebo at least 6 hours after Serving 1).

Creatine Bolus 5
Creatine Bolus 3DIETARY_SUPPLEMENT

(Serving 1: 3 grams of creatine + 5 grams of placebo in the morning; Serving 2: 8 grams of placebo at least 6 hours after Serving 1).

Creatine Bolus 3
Creatine Intermittent 5DIETARY_SUPPLEMENT

(Serving 1: 2.5 grams of creatine + 5.5 grams of placebo in the morning, Serving 2: 2.5 grams of creatine + 5.5 grams of placebo at least 6 hours after Serving 1).

Creatine Intermittent 5
PlaceboDIETARY_SUPPLEMENT

(Serving: 8 grams of placebo in the morning; Servings 2: 8 grams of placebo at least 6 hours after Serving 1).

Placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • if you are 50 years of age and older
  • if you have not been performing more than 1 resistance training session per week for the past 6 weeks or more.

You may not qualify if:

  • if you have taken creatine supplements 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, S4S4H4, Canada

RECRUITING

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 16, 2024

First Posted

September 23, 2024

Study Start

August 20, 2024

Primary Completion

July 30, 2025

Study Completion

July 30, 2025

Last Updated

September 23, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations