NCT06606717

Brief Summary

The primary purpose of this research is to compare the effects of creatine monohydrate and/or whey protein supplementation during the first 10 weeks of a 20-week resistance-band training program on measures of body composition (whole-body lean tissue mass, total body water), arm and leg muscle thickness, upper- and lower-body muscle performance (i.e., strength, endurance) and functional ability (walking speed, balance). A secondary purpose of this research is to examine the effects of supplementation cessation (i.e., no creatine and/or whey protein supplementation) during the final 10 weeks of the 20-week resistance-band training program on these measures.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 18, 2024

Completed
29 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
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 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

Resistance ExerciseCreatineWhey ProteinStrengthLean Mass

Outcome Measures

Primary Outcomes (7)

  • Whole-body lean mass (kg)

    Bioelectrical impedance analysis

    baseline, week 10, week 20

  • Strength (kg)

    1-repetition maximum leg press and chest press

    baseline, week 10, week 20

  • Endurance (number of repetitions to fatigue)

    Leg press and chest press

    baseline, week 10, week 20

  • Balance (Centre of Pressure)

    Force Plate

    baseline, week 10, week 20

  • Hydration (kg)

    Bioelectrical impedance analysis

    baseline, week 10, week 20

  • Gait Speed (meters)

    Walking distance

    baseline, week 10, week 20

  • Muscle Hypertrophy (cm)

    B-mode ultrasound

    baseline, week 10, week 20

Study Arms (2)

Creatine Whey Protein

EXPERIMENTAL
Dietary Supplement: Creatine Whey Protein

Whey Protein

EXPERIMENTAL
Dietary Supplement: Whey Protein

Interventions

Creatine Whey ProteinDIETARY_SUPPLEMENT

3 grams creatine + 30 grams whey protein

Creatine Whey Protein
Whey ProteinDIETARY_SUPPLEMENT

30 grams Whey Protein

Whey Protein

Eligibility Criteria

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

You may qualify if:

  • Untrained (defined as those performing ≤ 1 resistance training session per week for ≥ 6 weeks prior to the start of the study)

You may not qualify if:

  • Taking creatine monohydrate within 30 days prior to the start of the study
  • Currently ingesting whey protein
  • Have pre-existing allergies to latex, fruit, dairy, nuts, seafood and mustard

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Regina

Regina, Saskatchewan, S4S 0A2, Canada

RECRUITING

MeSH Terms

Interventions

Whey Proteins

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

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 18, 2024

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

September 23, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations