Cardiac and Vascular Responses to Creatine Supplementation in Elderly Men

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Function and Hemodynamics
• Intervention / Treatment: Dietary supplement: Creatine Monohydrate; Dietary supplement: Maltodextrin

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 Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adrian Aron; Phone Number: 5402246665; Email: aaron@radford.edu

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 24013
      • Recruiting
      • Carilion Roanoke Community Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Males
• 55-80 years old
• No restrictions based on race, ethnicity, or socioeconomic status

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Creatine Monohydrate Supplementation; 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).	Dietary supplement: Creatine Monohydrate; Creatine Monohydrate powder, 4 separate 5g doses per day for 7 days.
Placebo Comparator: Maltodextrin Supplementation; 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).	Dietary supplement: Maltodextrin; Maltodextrin powder, 4 separate 5g doses per day for 7 days.
No Intervention: Control; Participants in the control group do not receive a supplement (creatine or placebo) to ingest over the 7 day period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Baseline and day 8.

Collaborators and Investigators

• Sponsor: Radford University

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: March 7, 2022
• First Submitted That Met QC Criteria: April 7, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 13, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2021-431

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No