- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06606717
Effects of Resistance-band Training and Creatine and Whey Protein
September 18, 2024 updated by: Darren Candow, University of Regina
Effects of Resistance-band Training and Nutritional Supplementation in Healthy Older Adults
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Sarcopenia, characterized by the age-related reduction in strength, muscle mass, and physical function, decreases the ability to perform activities of daily living.
Physical inactivity and inadequate nutrition are contributing factors to the development of sarcopenia.
Resistance training is a safe, viable and effective intervention which increases measures of muscle and bone mass, muscle performance (i.e., strength, endurance) and functional ability in older adults.
However, older adults indicate that high costs and difficulty finding training programming and/or facilities are barriers to participating in resistance training.
Home-based resistance-band training is safe, effective and serves as a viable alternative to traditional resistance training (i.e., involving free-weights and machine-based equipment).
From a healthy aging perspective, resistance-band training elicits similar improvements in strength (primary indicator of sarcopenia) and functional ability compared to traditional resistance training in older adults.
In addition to resistance training (involving resistance-bands), creatine and whey protein supplementations have also been shown to have favorable effects on measures of muscle, bone and functional ability in older adults.
However, no study has examined the effects of resistance-band training and creatine and whey protein supplementation in older adults.
Study Type
Interventional
Enrollment (Estimated)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Darren Candow
- Phone Number: 306-585-4906
- Email: Darren.Candow@uregina.ca
Study Locations
-
-
Saskatchewan
-
Regina, Saskatchewan, Canada, S4S 0A2
- Recruiting
- University of Regina
-
Contact:
- Darren Candow
- Phone Number: 306-585-4906
- Email: Darren.Candow@uregina.ca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Untrained (defined as those performing ≤ 1 resistance training session per week for ≥ 6 weeks prior to the start of the study)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Whey Protein
|
30 grams Whey Protein
|
|
Experimental: Creatine Whey Protein
|
3 grams creatine + 30 grams whey protein
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Whole-body lean mass (kg)
Time Frame: baseline, week 10, week 20
|
Bioelectrical impedance analysis
|
baseline, week 10, week 20
|
|
Strength (kg)
Time Frame: baseline, week 10, week 20
|
1-repetition maximum leg press and chest press
|
baseline, week 10, week 20
|
|
Endurance (number of repetitions to fatigue)
Time Frame: baseline, week 10, week 20
|
Leg press and chest press
|
baseline, week 10, week 20
|
|
Balance (Centre of Pressure)
Time Frame: baseline, week 10, week 20
|
Force Plate
|
baseline, week 10, week 20
|
|
Hydration (kg)
Time Frame: baseline, week 10, week 20
|
Bioelectrical impedance analysis
|
baseline, week 10, week 20
|
|
Gait Speed (meters)
Time Frame: baseline, week 10, week 20
|
Walking distance
|
baseline, week 10, week 20
|
|
Muscle Hypertrophy (cm)
Time Frame: baseline, week 10, week 20
|
B-mode ultrasound
|
baseline, week 10, week 20
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Darren Candow, University of Regina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 18, 2024
Primary Completion (Estimated)
July 1, 2025
Study Completion (Estimated)
July 1, 2025
Study Registration Dates
First Submitted
September 16, 2024
First Submitted That Met QC Criteria
September 18, 2024
First Posted (Actual)
September 23, 2024
Study Record Updates
Last Update Posted (Actual)
September 23, 2024
Last Update Submitted That Met QC Criteria
September 18, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 825
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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