Cardiac Function and HemodynamicsNCT05329480
Cardiac and Vascular Responses to Creatine Supplementation in Elderly Men
A study testing Creatine Monohydrate and Maltodextrin in people with Cardiac Function and Hemodynamics, run by Radford University at 1 site in United States.
Trial summary
The purpose of this study is to investigate the impact of creatine supplementation alone or in combination with a moderate session of physical activity on vascular reactivity and heart hemodynamics in elderly men. Read more about this study
- Who is it for?
- Ages 55 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiac Function and Hemodynamics
- What is being tested?
- Creatine Monohydrate and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2022to Jun 2024
- 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 55 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males
- 55-80 years old
- No restrictions based on race, ethnicity, or socioeconomic status
Who cannot join
- Females
- <55 or >80 years old
- Individuals with known serious cardiac pathology
- Individuals with known serious kidney pathology
- Appropriate for moderate intensity exercise (screening using PAR-Q+)
- Individuals currently consuming or had consumed creatine supplement within 3 months prior to screening
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Carilion Roanoke Community Hospital
Roanoke, Virginia, 24013
About this study
The purpose of this study is to investigate the impact of creatine supplementation alone or in combination with a moderate session of physical activity on vascular reactivity and heart hemodynamics in elderly men.
Read the detailed description
Before beginning baseline testing, subjects' vitals will be measured (heart rate, blood pressure) in order to ensure that they are safe to participate in the submaximal exercise test. Subjects will also complete the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) to screen for cardiovascular risk factors. Information about physical activity level, medical history, and creatine supplementation use history will also be acquired. After anthropometric measurements, subjects will be asked to lay down in a hospital-type bed for measuring heart function and vascular responses at rest.
For measures of heart function, a non-invasive bioimpedance device will be used. Five ECG electrodes will be placed on chest and neck areas that will continuously collect information about heart rate, stroke volume, contractility index, ejection fraction and systemic vascular resistance. Vascular responses will be assessed using a non-invasive arterial pulse wave velocity equipment. This test uses four blood pressure cuffs placed on the wrists and calves, which, after 10 seconds inflation, are able to calculate an index of stiffness.
After resting values are collected, the cuffs will be removed, and subjects will be asked to walk on a treadmill at 6 km/h (3.1mph) and 5% grade for 10 minutes. During the treadmill walking, subjects will have their heart monitored using the non-invasive bioimpedance device with the ECG attached to their chest and neck. After 10 minutes have passed, subjects will be asked to step down from the treadmill and lay down on in the same hospital type bed.
At this time, the four blood pressure cuffs will be placed again on the wrists and calves to measure the vascular responses. We plan on performing two arterial stiffness measurements, after 10 and 20 minutes of the treadmill walking. After 20 minutes of monitoring while lying in bed, subjects will be disconnected from all ECGs and blood pressure cuffs.
Randomization in one of the three groups will occur using a computer generated sequence. The groups will have 15 subjects each and will consist of creatine supplementation, placebo supplementation (maltodextrin) and control (no supplementation). After randomization, subjects will receive their assigned packages containing the supplementation supplies corresponding to their group allocation (creatine or placebo). After 7 days of 20g/day supplementation, subjects will be asked to come back to the testing center for a repeat of the exercise test and corresponding heart monitoring and vascular responses before and after the treadmill walk.
To ensure good compliance with supplementation, subjects will receive daily text messages with reminders about their dose ingestion. The 20g/day will be divided in 4 dosages of 5g each that should be taken with water or other liquids throughout the day (breakfast, lunch, afternoon and evening).
- Conditions
- Cardiac Function and Hemodynamics
- Being tested
- Creatine Monohydrate, Maltodextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine MonohydrateDietary supplement
Creatine Monohydrate powder, 4 separate 5g doses per day for 7 days.
MaltodextrinDietary supplement
Maltodextrin powder, 4 separate 5g doses per day for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Creatine Monohydrate Supplementation | Experimental | Blinded subjects are instructed to ingest 20g of creatine monohydrate for 7 days divided into 4 dosages of 5g each that should be taken with water or other liquids throughout the day (breakfast, lunch, afternoon and evening). Receives: Dietary Supplement: Creatine Monohydrate |
| Maltodextrin Supplementation | Placebo comparator | Blinded subjects are instructed to ingest 20g of maltodextrin for 7 days divided into 4 dosages of 5g each that should be taken with water or other liquids throughout the day (breakfast, lunch, afternoon and evening). Receives: Dietary Supplement: Maltodextrin |
| Control | No intervention | Participants in the control group do not receive a supplement (creatine or placebo) to ingest over the 7 day period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in brachial-ankle pulse wave velocity (baPWV)
PWV is a validated, non-invasive, clinical technique used to measure arterial stiffness. Participants will lay supine, and 4 blood pressure cuffs will be wrapped around the limbs. One cuff on each arm (brachial artery) and one cuff on each ankle (posterior tibial artery). The distance between the two sampling points (arms and ankles) will be calculated according to the height of the subject. PWV is measured as the distance between two recording sites divided by the transit time of the pulse wave detected. PWV will be given as meters/second. Values will be measured at rest, during a 10 minute bout of exercise, 10 and 20 minutes post-exercise.
Measured: Baseline and day 8.
Secondary outcomes (5)
Stroke Volume
Determined by bioimpedance. The technique measures the change in impedance using a high frequency alternating electrical current (66 kHz) of low magnitude (4.5 mA peak to peak) between different electrodes positioned around the chest and neck. Values will be measured at rest, during a 10 minute bout of exercise, 10 and 20 minutes post-exercise.
Measured: Baseline and day 8.
Cardiac Index
Determined by bioimpedance. The technique measures the change in impedance using a high frequency alternating electrical current (66 kHz) of low magnitude (4.5 mA peak to peak) between different electrodes positioned around the chest and neck. Values will be measured at rest, during a 10 minute bout of exercise, 10 and 20 minutes post-exercise.
Measured: Baseline and day 8.
Systemic Vascular Resistance
Determined by bioimpedance. The technique measures the change in impedance using a high frequency alternating electrical current (66 kHz) of low magnitude (4.5 mA peak to peak) between different electrodes positioned around the chest and neck. Values will be measured at rest, during a 10 minute bout of exercise, 10 and 20 minutes post-exercise.
Measured: Baseline and day 8.
Ejection Fraction
Determined by bioimpedance. The technique measures the change in impedance using a high frequency alternating electrical current (66 kHz) of low magnitude (4.5 mA peak to peak) between different electrodes positioned around the chest and neck. Values will be measured at rest, during a 10 minute bout of exercise, 10 and 20 minutes post-exercise.
Measured: Baseline and day 8.
Contractility Index
Determined by bioimpedance. The technique measures the change in impedance using a high frequency alternating electrical current (66 kHz) of low magnitude (4.5 mA peak to peak) between different electrodes positioned around the chest and neck. Values will be measured at rest, during a 10 minute bout of exercise, 10 and 20 minutes post-exercise.
Measured: Baseline and day 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start9 Feb 2022
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Function and HemodynamicsStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrian Aron, Radford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329480
- Sponsor's protocol ID
- 2021-431
- Status last verified
- Apr 2024
- First submitted
- 7 Mar 2022
- Last updated
- 16 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aron A, Landrum EJ, Schneider AD, Via M, Evans L, Rawson ES. Effects of acute creatine supplementation on cardiac and vascular responses in older men; a randomized controlled trial. Clin Nutr ESPEN. 2024 Oct;63:557-563. doi: 10.1016/j.clnesp.2024.07.008. Epub 2024 Jul 22.
PubMed 39047868
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac and Vascular Responses to Creatine Supplementation in Elderly Men
- ClinicalTrials.gov ID
- NCT05329480
- Acronym / sponsor ID
- 2021-431
- Conditions
- Cardiac Function and Hemodynamics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Radford UniversityUniversity, hospital or other
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 15 Apr 2022 (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 purpose of this study is to investigate the impact of creatine supplementation alone or in combination with a moderate session of physical activity on vascular reactivity and heart hemodynamics in elderly men.
Detailed description
Before beginning baseline testing, subjects' vitals will be measured (heart rate, blood pressure) in order to ensure that they are safe to participate in the submaximal exercise test. Subjects will also complete the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) to screen for cardiovascular risk factors. Information about physical activity level, medical history, and creatine supplementation use history will also be acquired. After anthropometric measurements, subjects will be asked to lay down in a hospital-type bed for measuring heart function and vascular responses at rest.
For measures of heart function, a non-invasive bioimpedance device will be used. Five ECG electrodes will be placed on chest and neck areas that will continuously collect information about heart rate, stroke volume, contractility index, ejection fraction and systemic vascular resistance. Vascular responses will be assessed using a non-invasive arterial pulse wave velocity equipment. This test uses four blood pressure cuffs placed on the wrists and calves, which, after 10 seconds inflation, are able to calculate an index of stiffness.
After resting values are collected, the cuffs will be removed, and subjects will be asked to walk on a treadmill at 6 km/h (3.1mph) and 5% grade for 10 minutes. During the treadmill walking, subjects will have their heart monitored using the non-invasive bioimpedance device with the ECG attached to their chest and neck. After 10 minutes have passed, subjects will be asked to step down from the treadmill and lay down on in the same hospital type bed.
At this time, the four blood pressure cuffs will be placed again on the wrists and calves to measure the vascular responses. We plan on performing two arterial stiffness measurements, after 10 and 20 minutes of the treadmill walking. After 20 minutes of monitoring while lying in bed, subjects will be disconnected from all ECGs and blood pressure cuffs.
Randomization in one of the three groups will occur using a computer generated sequence. The groups will have 15 subjects each and will consist of creatine supplementation, placebo supplementation (maltodextrin) and control (no supplementation). After randomization, subjects will receive their assigned packages containing the supplementation supplies corresponding to their group allocation (creatine or placebo). After 7 days of 20g/day supplementation, subjects will be asked to come back to the testing center for a repeat of the exercise test and corresponding heart monitoring and vascular responses before and after the treadmill walk.
To ensure good compliance with supplementation, subjects will receive daily text messages with reminders about their dose ingestion. The 20g/day will be divided in 4 dosages of 5g each that should be taken with water or other liquids throughout the day (breakfast, lunch, afternoon and evening).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Creatine Monohydrate Supplementation | Experimental | Dietary Supplement: Creatine MonohydrateBlinded subjects are instructed to ingest 20g of creatine monohydrate for 7 days divided into 4 dosages of 5g each that should be taken with water or other liquids throughout the day (breakfast, lunch, afternoon and evening). |
| Maltodextrin Supplementation | Placebo comparator | Dietary Supplement: MaltodextrinBlinded subjects are instructed to ingest 20g of maltodextrin for 7 days divided into 4 dosages of 5g each that should be taken with water or other liquids throughout the day (breakfast, lunch, afternoon and evening). |
| Control | No intervention | –Participants in the control group do not receive a supplement (creatine or placebo) to ingest over the 7 day period. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males
- 55-80 years old
- No restrictions based on race, ethnicity, or socioeconomic status
Key exclusion criteria (6 listed)
- Females
- <55 or >80 years old
- Individuals with known serious cardiac pathology
- Individuals with known serious kidney pathology
- Appropriate for moderate intensity exercise (screening using PAR-Q+)
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 MonohydrateCreatine Monohydrate powder, 4 separate 5g doses per day for 7 days. | Dietary supplement | Creatine Monohydrate Supplementation |
| MaltodextrinMaltodextrin powder, 4 separate 5g doses per day for 7 days. | Dietary supplement | Maltodextrin Supplementation |
Primary outcome
Change from baseline in brachial-ankle pulse wave velocity (baPWV)
Time frame: Baseline and day 8.
PWV is a validated, non-invasive, clinical technique used to measure arterial stiffness. Participants will lay supine, and 4 blood pressure cuffs will be wrapped around the limbs. One cuff on each arm (brachial artery) and one cuff on each ankle (posterior tibial artery). The distance between the two sampling points (arms and ankles) will be calculated according to the height of the subject. PWV is measured as the distance between two recording sites divided by the transit time of the pulse wave detected. PWV will be given as meters/second. Values will be measured at rest, during a 10 minute bout of exercise, 10 and 20 minutes post-exercise.
5 secondary outcomes
Stroke Volume
Time frame: Baseline and day 8.
Cardiac Index
Time frame: Baseline and day 8.
Systemic Vascular Resistance
Time frame: Baseline and day 8.
Ejection Fraction
Time frame: Baseline and day 8.
Contractility Index
Time frame: Baseline and day 8.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Derived from this study: PubMed 39047868Aron A, Landrum EJ, Schneider AD, Via M, Evans L, Rawson ES. Effects of acute creatine supplementation on cardiac and vascular responses in older men; a randomized controlled trial. Clin Nutr ESPEN. 2024 Oct;63:557-563. doi: 10.1016/j.clnesp.2024.07.008. Epub 2024 Jul 22.
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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.
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 Monohydrate and Maltodextrin in people with Cardiac Function and Hemodynamics, run by Radford University at 1 site in United States.
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 3 inclusion and 6 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 16 Apr 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 United States. 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 Adrian Aron (5402246665, aaron@radford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in brachial-ankle pulse wave velocity (baPWV) (time frame: Baseline and day 8.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05329480, which also lists 1 linked publication.
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 16 Apr 2024.