Sarcopenia in ElderlyNCT06606717
Effects of Resistance-band Training and Creatine and Whey Protein
A study testing Creatine Whey Protein and Whey Protein in people with Sarcopenia in Elderly, run by University of Regina at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia in Elderly
- What is being tested?
- Creatine Whey Protein and Whey Protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- 18 Aug 2024to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Untrained (defined as those performing ≤ 1 resistance training session per week for ≥ 6 weeks prior to the start of the study)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Regina
Regina, Saskatchewan, S4S 0A2
Darren Candow, 306-585-4906, Darren.Candow@uregina.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Sarcopenia in Elderly
- Being tested
- Creatine Whey Protein, Whey Protein
- Keywords
- Resistance Exercise, Creatine, Whey Protein, Strength, Lean Mass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine Whey ProteinDietary supplement
3 grams creatine + 30 grams whey protein
Whey ProteinDietary supplement
30 grams Whey Protein
| Study group | Role | What they receive |
|---|---|---|
| Creatine Whey Protein | Experimental | Not described Receives: Dietary Supplement: Creatine Whey Protein |
| Whey Protein | Experimental | Not described Receives: Dietary Supplement: Whey Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole-body lean mass (kg)
Bioelectrical impedance analysis
Measured: baseline, week 10, week 20
Strength (kg)
1-repetition maximum leg press and chest press
Measured: baseline, week 10, week 20
Endurance (number of repetitions to fatigue)
Leg press and chest press
Measured: baseline, week 10, week 20
Balance (Centre of Pressure)
Force Plate
Measured: baseline, week 10, week 20
Hydration (kg)
Bioelectrical impedance analysis
Measured: baseline, week 10, week 20
Gait Speed (meters)
Walking distance
Measured: baseline, week 10, week 20
Muscle Hypertrophy (cm)
B-mode ultrasound
Measured: baseline, week 10, week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start18 Aug 2024
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcopenia in ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Regina
- Sponsor type
- University, hospital or other
- Collaborators
- Iovate Health Sciences International Inc
- Responsible party
- Principal investigator, Darren Candow, University of Regina
- Investigators
- Darren Candow, Principal investigator, University of Regina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606717
- Sponsor's protocol ID
- 825
- Status last verified
- Sep 2024
- First submitted
- 16 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resistance-band Training and Nutritional Supplementation in Healthy Older Adults
- ClinicalTrials.gov ID
- NCT06606717
- Acronym / sponsor ID
- 825
- Conditions
- Sarcopenia in Elderly
- Keywords
- Resistance Exercise, Creatine, Whey Protein, Strength, Lean Mass
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of ReginaUniversity, hospital or other
- Collaborators
- Iovate Health Sciences International Inc
- Study start
- 18 Aug 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Creatine Whey Protein | Experimental | Dietary Supplement: Creatine Whey Protein |
| Whey Protein | Experimental | Dietary Supplement: Whey Protein |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Untrained (defined as those performing ≤ 1 resistance training session per week for ≥ 6 weeks prior to the start of the study)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Creatine Whey Protein3 grams creatine + 30 grams whey protein | Dietary supplement | Creatine Whey Protein |
| Whey Protein30 grams Whey Protein | Dietary supplement | Whey Protein |
Primary outcome
Whole-body lean mass (kg)
Time frame: baseline, week 10, week 20
Bioelectrical impedance analysis
Strength (kg)
Time frame: baseline, week 10, week 20
1-repetition maximum leg press and chest press
Endurance (number of repetitions to fatigue)
Time frame: baseline, week 10, week 20
Leg press and chest press
Balance (Centre of Pressure)
Time frame: baseline, week 10, week 20
Force Plate
Hydration (kg)
Time frame: baseline, week 10, week 20
Bioelectrical impedance analysis
Gait Speed (meters)
Time frame: baseline, week 10, week 20
Walking distance
Muscle Hypertrophy (cm)
Time frame: baseline, week 10, week 20
B-mode ultrasound
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darren Candow principal investigator
University of Regina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine Whey Protein and Whey Protein in people with Sarcopenia in Elderly, run by University of Regina at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Darren Candow (306-585-4906, Darren.Candow@uregina.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole-body lean mass (kg) (time frame: baseline, week 10, week 20). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.