Carnosine Supplementation and Cardiovascular Function

Study Overview
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Brief Summary
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Carnosine is a dipeptide synthesized in the body from β-alanine and L-histidine. It was originally discovered in skeletal muscle where it is present in larger amounts than in other tissues, but it is also found in high concentrations in the brain, heart, and gastrointestinal tissues of humans. Although its physiological role has not been completely understood yet, carnosine is a non-enzymatic free-radical scavenger and a natural antioxidant and has anti-inflammatory and neuroprotective properties. The hypothesis of this research is that the consumption of carnosine supplements in the form of capsules, as well as chicken meat enriched with carnosine (functional food) has a beneficial effect on vascular reactivity measured in different vascular basins, and the lipid profile with a positive effect on the reduction of oxidative stress and inflammatory response in healthy sedentary people. subjects and active athletes measured in different vascular basins. The main goal of this study is to investigate the influence of carnosine supplement consumption (in the form of capsules and functional food) on vascular and endothelial function in a population of healthy young subjects and active athletes.

Official Title
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Effects of Carnosine Supplementation in Form of Capsules and Functional Food on Cardiovascular Function

Conditions
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Carnosine

Intervention / Treatment
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* Dietary Supplement: Carnosine supplementation
* Dietary Supplement: Controls


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: young healthy sedentary individuals - did not perform regular physical activities for at least 12 months before conducting the study young healthy active athletes - have a minimum of 5 training sessions per week (mainly endurance training) for at least 12 months prior to conducting the study Exclusion Criteria: smoking hypertension coronary disease diabetes hyperlipidemia kidney damage cerebrovascular and peripheral artery diseases and any other disease that could have an impact on vascular and endothelial function

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carnosine<br>Intake of carnosine supplement in form of capsules or functionally enriched chicken meet for three weeks | Dietary Supplement: Carnosine supplementation<br>* Intake of carnosine supplement in form of capsules or functionally enriched chicken meet for three weeks<br>|
| Placebo Comparator: Control<br>Intake of placebo capsules or regular chicken meet for three weeks | Dietary Supplement: Controls<br>* Intake of placebo capsules or regular chicken meet for three weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microvascular endothelial function | Cutaneous microvascular blood flow will be measured by Laser Doppler Flowmetry in response to vascular occlusion (post occlusive reactive hyperaemia - PORH), in response to iontophoresis of acetylcholine (ACh) and local thermal hyperemia (LTH). | 3 weeks | 
| Macrovascular endothelial function | Measurement of flow mediated dilation (FMD) of brachial artery using ultrasound. | 3 weeks | 
| Cerebrovascular reactivity | Measurement of cerebrovascular blood flow using transcranial color Doppler (TCD). | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid profile | Measurement of plasma cholesterol, HDL cholesterol, LDL cholesterol and triglycerides level. | 3 weeks | 
| Oxidative stress status | Measurement of Thiobarbituric Acid Reactive Substances (TBARS). | 3 weeks | 
| Systemic hemodynamics | Non-invasive assessment of systemic hemodynamics using impedance cardiography (CardioScreen 2000) - SV Stroke Volume (mL). | 3 weeks | 
| Serum Pro- and Anti-Inflammatory Cytokines, Chemokines, Growth Factors and Soluble Cell Adhesion Molecules Protein Concentration | Measurement of serum protein concentration (pg/mL) of various pro- and anti-inflammatory cytokines, chemokines, growth factors and soluble cell adhesion molecules by kits and panels for multiplex protein quantitation using the Luminex 200 instrument platform. | 3 weeks | 
| Body composition | Body composition and body fluid status measurement by a four-terminal portable impedance analyzer. Based on the value of skin resistance (Ohm) empirically derived formulas (the original manufacturer's software) will be used to calculate the estimated Fat Free Mass (FFM kg) and Fat (Fat Mass kg). | 3 weeks | 
| Body fluid status | Body fluid status measurement by a four-terminal portable impedance analyzer. Based on the value of skin resistance (Ohm) empirically derived formulas (the original manufacturer's software) will be used to calculate the estimated Total Body Water (TBW L), Extracellular Water (ECW L), Intracellular Water (ICW L), Plasma Fluid (PF L) and Interstitial Fluid (IF L). | 3 weeks | 
| Oxidative stress status | Measurement of Ferric-Reducing Ability of Plasma (FRAP). | 3 weeks | 
| Oxidative stress status | Measurement of enzyme activity assay of glutathione peroxidase (GPx). | 3 weeks | 
| Systemic hemodynamics | Non-invasive assessment of systemic hemodynamics using impedance cardiography (CardioScreen 2000) - CO Cardiac Output (L/min). | 3 weeks | 
| Systemic hemodynamics | Non-invasive assessment of systemic hemodynamics using impedance cardiography (CardioScreen 2000) - SVRI Systemic Vascular Resistance Index (dyn.s.cm-5 m2). | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carnosine, oxidative stress, vascular reactivity, endothelium, inflammation, microcirculation, macrocirculation