Clinical trial NCT04732754: Effect of Cocoa Supplementation and Aerobic Exercise on Pressure Parameters
Official title: Effect of Cocoa Supplementation and Aerobic Exercise on Central Pressure and Arterial Stiffness Parameters in Physically Inactive Middle-aged Individuals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sedentary Behavior
Keywords: Flavonoids
Cocoa
Arterial Stiffness
Physical Exercise
Central blood pressure
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2021-02-01
Enrollment: 84
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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);

Primary outcomes:
measure: Arterial Stiffness by Pulse Wave Velocity
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia
state: Rio Grande Do Sul
Study officials:
affiliation: Instituto de Cardiologia
name: Tainah Ortiz, M.Sc
role: PRINCIPAL_INVESTIGATOR
References: