Effect of Cocoa Supplementation and Aerobic Exercise on Pressure Parameters

Study Overview
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Brief Summary
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This study evaluates the cocoa supplementation and aerobic exercise on central pressure and arterial stiffness parameters in physically inactive middle-aged individuals. 500mg capsules will be offered to all patients. Of these, half will offer the content of 500mg of cocoa per capsule or placebo capsules. The placebo will contain a pharmacologically inert substance (microcrystalline cellulose) of the same color. A half will start 50' aerobic training 3 times/week while the other half will continue without exercise.

Detailed Description
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Cardiovascular diseases (CVDs) are the number one cause of death in the world: more people die annually from CVDs than from any other cause. The arterial hypertension is one of the main predictors of CVDs. The number of adults with high blood pressure increased from 594 million in 1975 to 1.13 billion in 2015( WHO, 2020). Due to the great increase in Hypertension around the world, new technological ways of assessing pressure have been discussed in the clinical setting, not only peripheral, but also central. In this sense, the applanation tonometry of different arteries (carotid and radial), the analysis of pulses by various algorithms and the ability to estimate the shape of the pulse wave in the descending aorta root has been gaining prominence. Flavonoids are a group of polyphenol compounds found in plants. The possible benefits from these compounds are related to cardiovascular health through specific actions on the artery wall. Prospective studies have shown that flavonoids can improve arterial stiffness, measured by Pulse Wave Velocity (PWV). Physical exercise can intensifies organic functioning in different systems oh human body, including the cardiovascular. Studies has shown that chronic adaptations of pshysical exercise can improve arterial stiffness and central blood pressure parameters.

Official Title
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Effect of Cocoa Supplementation and Aerobic Exercise on Central Pressure and Arterial Stiffness Parameters in Physically Inactive Middle-aged Individuals

Conditions
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Sedentary Behavior

Intervention / Treatment
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* Dietary Supplement: Aerobic exercise + Theobroma cocoa (AETC)
* Dietary Supplement: Control Group (CG)
* Dietary Supplement: Aerobic Exercise (AE)
* Dietary Supplement: Theobroma Cocoa (TC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sedentary lifestyle (IPAQ- International Physical Activity Questionnaire); Eutrophic or overweight (BMI >18,5kg/m² and <30kg/m²). Exclusion Criteria: Individuals with a feverish state and / or infectious disease; Individuals with diabetes mellitus or coronary artery disease; Individuals who have any recent cardiovascular events (last 3 months) or chronic renal failure; history of malignant diseases with life expectancy <2 years; Use of statins; Smokers (those who have never smoked or smoked less than 100 cigarettes (5 bags of 20 cigarettes) in their lifetime and for at least 5 years); Alcoholics (The WHO estabilish ad acceptable the consumption is up to 15 doses / week for men and 10 for women, with 1 dose equivalent to approximately 350 mL of beer, 150 mL of wine or 40 mL of a distilled drink, considering that each contains between 10 and 15 g of ethanol);

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group (CG)<br>This group will receive placebo capsules to be consumed for 8 weeks daily and will not exercise; | Dietary Supplement: Control Group (CG)<br>* Daily consumption of placebo capsules for 8 weeks<br>|
| Active Comparator: Aerobic Exercise (AE)<br>This group will receive placebo capsules and will perform 3 sessions of physical exercise / week, 50 min / session, with moderate intensity of 50-70% of VO2peak for 8 weeks. | Dietary Supplement: Aerobic Exercise (AE)<br>* Daily consumption of placebo capsules and 3 sessions of physical exercise / week, 50 min / session, with moderate intensity of 50-70% of VO2peak for 8 weeks.<br>|
| Experimental: Aerobic exercise + Theobroma cocoa (AETC)<br>This group will receive 500mg cocoa capsules to be consumed daily and will perform 3 sessions of physical exercise / week, 50 min / session, with moderate intensity of 50-70% VO2peak) for 8 weeks | Dietary Supplement: Aerobic exercise + Theobroma cocoa (AETC)<br>* Daily consumption of 500mg cocoa in capsules and 3 sessions of physical exercise / week, 50 min / session, with moderate intensity of 50-70% of VO2peak for 8 weeks.<br>|
| Experimental: Theobroma cocoa (TC)<br>This group will receive 500mg cocoa capsules to be consumed daily for 8 weeks. | Dietary Supplement: Theobroma Cocoa (TC)<br>* Daily consumption of 500mg cocoa in capsules for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial Stiffness by Pulse Wave Velocity | The assessment of arterial stiffness will be carried out using the non-invasive method of PWV , which is obtained by dividing the carotid-femoral distance by the systolic wave travel time (in the unit of m / s) It will be checked by the Complior Analyzer equipment, with the volunteer in a supine position in an air-conditioned environment and controlled lighting in a LIC room, with the sensors placed over the right carotid and femoral arteries. The distance between the two points is measured by an infantometer and the data of pressure, total body weight and distance between the points of the sensors in the carotid artery and in the femoral artery are entered in the software to calculate the PWV. This analysis will be carried out before and after the intervention period. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flavonoids, Cocoa, Arterial Stiffness, Physical Exercise, Central blood pressure