AgingNCT06606704
Effects of Resistance-band Training and Creatine Supplementation Strategies in Healthy Older Adults
A study testing Creatine Bolus 5, Creatine Bolus 3 and Creatine Intermittent 5 in people with Aging, run by University of Regina at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Creatine Bolus 5, Creatine Bolus 3 and Creatine Intermittent 5
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- 20 Aug 2024to 30 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
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Regina
Regina, Saskatchewan, S4S4H4
Darren G Candow, PhD, 3062090280, Darren.Candow@uregina.ca
Darren G Candow, PhD
About this study
Official title: Effects of Resistance-band Training and Creatine Supplementation in Healthy Older Adults
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).
Read the detailed description
Resistance-band training is safe, conveient, easy-to-use, eliminates potential barriers to exercise participation (i.e., lack of transportation to and from commercial training facilities) and results in high exercise compliance and adherence. Further, resistance-band training results in similar improvements in muscle performance and functional ability compared to traditional resistance-type training using free-weights and machines.
Creatine is a naturally occurring nitrogen-containing compound produced in the body in the liver and brain and can also be found in food products such as red meat and seafood or through commercially available manufactured creatine products.
Evidence-based research shows that creatine supplementation, when ingested during a resistance exercise training program, improves measures of lean mass and muscle growth, muscle performance and functional ability. However, the optimal creatine supplementation protocol to achieve these benefits is unknown.
- Conditions
- Aging
- Being tested
- Creatine Bolus 5, Creatine Bolus 3, Creatine Intermittent 5, Placebo
- Keywords
- Aging, Creatine, Resistance-Bands, Muscle, Strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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 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).
PlaceboDietary supplement
(Serving: 8 grams of placebo in the morning; Servings 2: 8 grams of placebo at least 6 hours after Serving 1).
| Study group | Role | What they receive |
|---|---|---|
| Creatine Bolus 5 | Experimental | Not described Receives: Dietary Supplement: Creatine Bolus 5 |
| Creatine Bolus 3 | Experimental | Not described Receives: Dietary Supplement: Creatine Bolus 3 |
| Creatine Intermittent 5 | Experimental | Not described Receives: Dietary Supplement: Creatine Intermittent 5 |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
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 16
Muscle Hypertrophy (cm)
B-mode ultrasound
Measured: baseline, week 16
Strength (kg)
1-repetition maximum leg press and chest press
Measured: baseline, week 16
Endurance (number of repetitions to fatigue)
Leg press and chest press
Measured: baseline, week 16
Power (feet)
medicine ball throw
Measured: baseline, week 16
Balance (Centre of Pressure)
Force Plate
Measured: baseline, week 16
Gait Speed (meters)
Walking distance
Measured: baseline, week 16
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 start20 Aug 2024
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- 52 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
- NCT06606704
- Sponsor's protocol ID
- 853
- 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 Creatine Supplementation in Healthy Older Adults
- ClinicalTrials.gov ID
- NCT06606704
- Acronym / sponsor ID
- 853
- Conditions
- Aging
- Keywords
- Aging, Creatine, Resistance-Bands, Muscle, Strength
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of ReginaUniversity, hospital or other
- Collaborators
- Iovate Health Sciences International Inc
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 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 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).
Detailed description
Resistance-band training is safe, conveient, easy-to-use, eliminates potential barriers to exercise participation (i.e., lack of transportation to and from commercial training facilities) and results in high exercise compliance and adherence. Further, resistance-band training results in similar improvements in muscle performance and functional ability compared to traditional resistance-type training using free-weights and machines.
Creatine is a naturally occurring nitrogen-containing compound produced in the body in the liver and brain and can also be found in food products such as red meat and seafood or through commercially available manufactured creatine products.
Evidence-based research shows that creatine supplementation, when ingested during a resistance exercise training program, improves measures of lean mass and muscle growth, muscle performance and functional ability. However, the optimal creatine supplementation protocol to achieve these benefits is unknown.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
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 Bolus 5(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). | Dietary supplement | Creatine Bolus 5 |
| Creatine Bolus 3(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). | Dietary supplement | Creatine Bolus 3 |
| Creatine Intermittent 5(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). | Dietary supplement | Creatine Intermittent 5 |
| Placebo(Serving: 8 grams of placebo in the morning; Servings 2: 8 grams of placebo at least 6 hours after Serving 1). | Dietary supplement | Placebo |
Primary outcome
Whole-body lean mass (kg)
Time frame: baseline, week 16
Bioelectrical impedance analysis
Muscle Hypertrophy (cm)
Time frame: baseline, week 16
B-mode ultrasound
Strength (kg)
Time frame: baseline, week 16
1-repetition maximum leg press and chest press
Endurance (number of repetitions to fatigue)
Time frame: baseline, week 16
Leg press and chest press
Power (feet)
Time frame: baseline, week 16
medicine ball throw
Balance (Centre of Pressure)
Time frame: baseline, week 16
Force Plate
Gait Speed (meters)
Time frame: baseline, week 16
Walking distance
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 Bolus 5, Creatine Bolus 3 and Creatine Intermittent 5 in people with Aging, 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 2 inclusion and 2 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. Some participants in this study may receive a placebo. 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 16). 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.