NCT05014659

Creatine Monohydrate Supplementation and Vascular Endothelial Health

The Impact of Creatine Supplementation on Vascular Endothelial Function, Blood Flow and Functional Exercise Capacity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Florida State University · Academic / Other
• Sex: All
• Age: 50 Years – 64 Years
• Healthy volunteers: Accepted

Summary

To determine the effects of 4 weeks of creatine monohydrate supplementation on markers of macrovascular and microvascular function, cognitive performance, and physical performance.

Detailed description

This is a randomized, double-blind (participant and principle investigator), placebo-controlled, crossover study. After a pre-screen telephone interview, potential participants will be invited to Florida State University for a "Screening visit". During this visit, individuals will be provided with a verbal and written explanation of the study. Individuals will complete an informed consent, a health history questionnaire and physical activity readiness questionnaire. If they meet study inclusion criteria, they will undergo anthropometric measurements and a venous blood draw to determine cardiovascular and kidney disease risk profile. If cleared for participation, participants will be asked to complete a "3-Day Food Log" prior to their next visit. Once qualified, participants will return to the laboratory to undergo their "Baseline Testing Visit". Following the completion of the first "Baseline Testing Visit", participants will be randomly assigned to one of two interventions: 1) creatine monohydrate; or, 2) maltodextrin "placebo". Participants will be given their supplement and asked to complete the supplementation protocol, complying with instructions given. Following the 4-week supplementation period, participants will return to the laboratory for their "Post-Supplement #1 Testing". During this visit, all procedures from the "Baseline Testing Visit" will be repeated. Once these measurements are completed, participants will be asked to return to their normal daily lifestyles for a 4-week "wash-out" period. During these 4-weeks, participants will be contacted weekly to ensure retention and to schedule the next visit. Following the washout, participants will return to the laboratory to undergo another "Baseline Testing Visit", completing the exact procedures as outlined previously. Following this, participants will be given their remaining supplement intervention. Following the intervention, participants will return to the lab for their final "Post-Supplement #2 Testing" to conclude the study.

Conditions

• Endothelial Dysfunction
• Oxidative Stress

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Creatine monohydrate	4 x 5g doses daily for 5 days, followed by 1 x 5g dose daily for 23 days.
DIETARY_SUPPLEMENT	Placebo	4 x 5g doses daily for 5 days, followed by 1 x 5g dose daily for 23 days.

Timeline

• Start date: 2020-10-17
• Primary completion: 2022-12-12
• Completion: 2022-12-12
• First posted: 2021-08-20
• Last updated: 2023-01-13

Locations

1 site across 1 country: United States