Cardiac and Vascular Responses to Creatine Supplementation in Elderly Men
1 other identifier
interventional
45
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 9, 2022
CompletedFirst Submitted
Initial submission to the registry
March 7, 2022
CompletedFirst Posted
Study publicly available on registry
April 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedApril 16, 2024
April 1, 2024
2.3 years
March 7, 2022
April 13, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline and day 8.
Secondary Outcomes (5)
Stroke Volume
Baseline and day 8.
Cardiac Index
Baseline and day 8.
Systemic Vascular Resistance
Baseline and day 8.
Ejection Fraction
Baseline and day 8.
Contractility Index
Baseline and day 8.
Study Arms (3)
Creatine Monohydrate Supplementation
EXPERIMENTALBlinded 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 COMPARATORBlinded 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 INTERVENTIONParticipants in the control group do not receive a supplement (creatine or placebo) to ingest over the 7 day period.
Interventions
Creatine Monohydrate powder, 4 separate 5g doses per day for 7 days.
Maltodextrin powder, 4 separate 5g doses per day for 7 days.
Eligibility Criteria
You may qualify if:
- Males
- years old
- No restrictions based on race, ethnicity, or socioeconomic status
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Carilion Roanoke Community Hospital
Roanoke, Virginia, 24013, United States
Related Publications (1)
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.
PMID: 39047868DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 7, 2022
First Posted
April 15, 2022
Study Start
February 9, 2022
Primary Completion
June 1, 2024
Study Completion
June 1, 2024
Last Updated
April 16, 2024
Record last verified: 2024-04