Healthy Behavior Clinical Trial
Official title:
Effects of Photobiomodulation on Endothelial Function, Blood and Endothelial Markers, and Nitric Oxide Metabolites in Healthy Subjects.
Verified date | March 2020 |
Source | Federal University of Health Science of Porto Alegre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The endothelial cell layer is responsible for the control of vascular homeostasis, a process mediated by vasoconstricting and vasodilatory substances. The principal endothelium-dependent vascular dilator is nitric oxide (NO), and the reduction of its synthesis or bioavailability is the main cause for the development of endothelial dysfunction. The use of photobiomodulation may be beneficial in several clinical situations. At the endothelial level, the stimulatory effects on vascular endothelial growth factor, NO secretion, number of capillaries and proliferation of endothelial cells are outstanding. The objective of this study is to evaluate the effects of photobiomodulation on the arterial endothelial function of healthy individuals. The study design will be a randomized, crossover, clinical trial and the sample will be composed of subjects selected by the eligibility criteria, and randomly randomized according to the order of intervention of the groups. The hypothesis is that at the end of the protocol with photobiomodulation an increase in endothelial function and blood markers of endothelial function occurs, and no tissue temperature variation.
Status | Active, not recruiting |
Enrollment | 16 |
Est. completion date | December 30, 2020 |
Est. primary completion date | December 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Age between 18-40 years - Body mass index (BMI: kg / m2) lower than 30 - Absence of symptoms of musculoskeletal disorders - No use of medications - Non-smokers and / or alcoholics - Absence of previous diagnosis of diseases Rheumatological, cardiovascular, renal, metabolic, neurological, oncological, immunological, hematological, psychiatric or cognitive. Exclusion Criteria: On the days of evaluation and intervention: - Individuals who performed high intensity physical activity in the previous 72 hours - Individuals who had an inflammatory response (> 3 mg / dL, fibrinogen <200 or> 400mg / dL) or leukocytosis (> 11,000 x103 / Mm3) - Individuals who have consumed caffeine, juices or citrus fruits, high-fat foods and alcohol in the 12 hours prior to the test - Individuals who are not fasting for 12 hours - Individuals who have used anti-inflammatory, antipyretic or analgesic drugs - Individuals who having an arterial diameter <0.25 mm or> 5.0 mm - Individuals with present endothelial dysfunction evaluated by the FMD technique (dilation <8%). |
Country | Name | City | State |
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Brazil | Federal University of Health Science of Porto Alegre (UFCSPA) | Porto Alegre | Rio Grande Do Sul |
Lead Sponsor | Collaborator |
---|---|
Rodrigo Della Méa Plentz | Federal University of Health Science of Porto Alegre |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in arterial endothelial function | The assessment of arterial endothelial function will be performed through the technique of flow-mediated dilatation, by high resolution ultrasound | The evaluation of the arterial endothelial function will be performed 20 minutes before and 20 minutes after the intervention with photobiostimulation | |
Secondary | Change in body temperature | The local temperature will be evaluated by thermography | The evaluation of the arterial endothelial function will be performed 15 minutes before and 15 minutes after the intervention with photobiostimulation | |
Secondary | Change in inflammatory profile | The inflammatory profile will be evaluated by C-reactive protein dosage | Basal blood collection (5 minutes before) and immediately after each intervention (5 minutes after) | |
Secondary | Change in arterial endothelial function (vasodilatation) | The vasodilatation will be evaluated by nitrite/nitrate dosage | Basal blood collection (5 minutes before) and immediately after each intervention (5 minutes after) | |
Secondary | Time of blood vessel dilation | The duration of the vasodilation of brachial artery after photobiomodulation | The measurement of the brachial artery vasodilation time (Cruz 2016; Iida 2006) was made before (baseline), immediately after and every two minutes until completing 20 minutes of evaluation after photobiomodulation |