Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06009276
Status:
RECRUITING
Last Update Posted:
2023-11-29
First Post:
2023-08-18
Brief Title:
Associations Between the Microbiome Skeletal Muscle Perfusion and Fitness Status
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Associations Between the Microbiome Skeletal Muscle Perfusion and Fitness Status
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to determine associations between fitness status bacteria in the mouth and the blood flow to muscle This study is trying to find out if fitness status impacts the bacteria that are present in the oral microbiome environment in the mouth or the ability of the body to send blood to the skeletal muscle
Participants will complete all or some of the following
A mouth swab to assess the bacteria in their mouths
Produce a saliva sample into a tube
Cycle on a bike until you reach maximum effort
Undergo blood draws
Wear a 24-hour non-invasive device that monitors blood pressure
Undergo a test to assess blood flow to the muscles measured with an ultrasound
Drink 70mL 13 of a cup of concentrated beetroot juice once
Participants will complete all or some of the following
A mouth swab to assess the bacteria in their mouths
Produce a saliva sample into a tube
Cycle on a bike until you reach maximum effort
Undergo blood draws
Wear a 24-hour non-invasive device that monitors blood pressure
Undergo a test to assess blood flow to the muscles measured with an ultrasound
Drink 70mL 13 of a cup of concentrated beetroot juice once
Detailed Description:
Cardiovascular disease CVD is the leading cause of morbidity and mortality in the United States Nitric oxide NO is a gaseous diatomic free-radical and is essential for a plethora of physiological functions involved in cardiometabolic health and CVD risk NO bioavailability is associated with greater tissue perfusion mitochondrial function glucose regulation and overall reduced CVD risk The primary source of circulating NO is vascular endothelial nitric oxide synthase
Unfortunately the endothelium can be disrupteddamaged via a variety of CVD risk factors such as hypertension smoking hyperlipidemia diabetes inflammation and hypercholesteremia Disruption of the vascular endothelium and loss of bioavailable NO is a preliminary step in the progression of atherosclerosis and CVD Decreased NO bioavailability and vascular dysfunction have been shown in a variety of clinical conditions including patients heart failure and peripheral artery disease PAD
Recently an exogenous approach to increasing NO bioavailability via oral supplementation of inorganic nitrate NO3- has been utilized to increase NO bioavailability in various healthy and clinical populations Briefly inorganic NO3- is swallowed absorbed into the circulation and sequestered back into the salivary glands NO3- is then secreted into the oral cavity where bacteria containing nitrate reductase enzymes convert NO3- to nitrite NO2- which is again swallowed and absorbed into the circulation NO2- in the plasma is then easily reduced to NO via non-enzymatic reactions
This study aims to better elucidate the relationship between the oral microbiome abundance and diversity and NO3- to NO2- to NO conversion across a variety of subject populations ranging from healthy subjects to those with risk factors for CVD and people with diagnosed CVD We also aim to examine the relationship between oral microbiome NO3- reduction and impaired skeletal muscle perfusion and exercise capacity as NO bioavailability plays a large role in these physiological processes
The results of this study may allow us to better understand how novel interventions to modify the oral microbiome may improve cardiometabolic health and physical function in individuals with CVD and outline potential new therapeutic approaches
The primary objective of this preliminary study is to compare the abundance and diversity of oral NO3- reducing bacteria in a variety of subjects with varying cardiometabolic health status and their ability to convert oral inorganic nitrate to nitrite measured in the saliva and plasma
A secondary objective is to determine associations between the abundance and diversity of oral NO3- reducing bacteria and both skeletal muscle tissue perfusion during exercise and exercise capacity A tertiary objective is to determine the stability of these relationships over time following lifestyle modifications ie exercise diet
Unfortunately the endothelium can be disrupteddamaged via a variety of CVD risk factors such as hypertension smoking hyperlipidemia diabetes inflammation and hypercholesteremia Disruption of the vascular endothelium and loss of bioavailable NO is a preliminary step in the progression of atherosclerosis and CVD Decreased NO bioavailability and vascular dysfunction have been shown in a variety of clinical conditions including patients heart failure and peripheral artery disease PAD
Recently an exogenous approach to increasing NO bioavailability via oral supplementation of inorganic nitrate NO3- has been utilized to increase NO bioavailability in various healthy and clinical populations Briefly inorganic NO3- is swallowed absorbed into the circulation and sequestered back into the salivary glands NO3- is then secreted into the oral cavity where bacteria containing nitrate reductase enzymes convert NO3- to nitrite NO2- which is again swallowed and absorbed into the circulation NO2- in the plasma is then easily reduced to NO via non-enzymatic reactions
This study aims to better elucidate the relationship between the oral microbiome abundance and diversity and NO3- to NO2- to NO conversion across a variety of subject populations ranging from healthy subjects to those with risk factors for CVD and people with diagnosed CVD We also aim to examine the relationship between oral microbiome NO3- reduction and impaired skeletal muscle perfusion and exercise capacity as NO bioavailability plays a large role in these physiological processes
The results of this study may allow us to better understand how novel interventions to modify the oral microbiome may improve cardiometabolic health and physical function in individuals with CVD and outline potential new therapeutic approaches
The primary objective of this preliminary study is to compare the abundance and diversity of oral NO3- reducing bacteria in a variety of subjects with varying cardiometabolic health status and their ability to convert oral inorganic nitrate to nitrite measured in the saliva and plasma
A secondary objective is to determine associations between the abundance and diversity of oral NO3- reducing bacteria and both skeletal muscle tissue perfusion during exercise and exercise capacity A tertiary objective is to determine the stability of these relationships over time following lifestyle modifications ie exercise diet
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None