Effect of Cocoa Supplementation and Aerobic Exercise on Pressure Parameters

Instituto de Cardiologia do Rio Grande do Sul

Status: Unknown

Conditions: Sedentary Behavior

Treatments: Dietary Supplement: Aerobic Exercise (AE); Dietary Supplement: Aerobic exercise + Theobroma cocoa (AETC); Dietary Supplement: Control Group (CG); Dietary Supplement: Theobroma Cocoa (TC)

Study type: Interventional

Funder types: Other

Identifiers

NCT04732754

UP 5839.20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 estimated patients

Sex: All

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

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);

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 4 patient groups, including a placebo group

Control Group (CG)

Placebo Comparator group

Description:

This group will receive placebo capsules to be consumed for 8 weeks daily and will not exercise;

Treatment:

Dietary Supplement: Control Group (CG)

Aerobic Exercise (AE)

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Aerobic Exercise (AE)

Aerobic exercise + Theobroma cocoa (AETC)

Experimental group

Description:

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

Treatment:

Dietary Supplement: Aerobic exercise + Theobroma cocoa (AETC)

Theobroma cocoa (TC)

Experimental group

Description:

This group will receive 500mg cocoa capsules to be consumed daily for 8 weeks.

Treatment:

Dietary Supplement: Theobroma Cocoa (TC)