Effect of Cocoa Supplementation and Aerobic Exercise on Pressure Parameters

Sedentary Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04732754
• Other study ID #: UP 5839.20
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 10, 2022

Study information

• Verified date: August 2021
• Source: Instituto de Cardiologia do Rio Grande do Sul
• Contact: Tainah Ortiz, M.Sc
• Phone: 55 51 999171990
• Email: tainahortiz05[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: December 10, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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);

Related Conditions & MeSH terms

• Sedentary Behavior

Intervention

Dietary Supplement:
• Aerobic exercise + Theobroma cocoa (AETC)
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.
• Control Group (CG)
Daily consumption of placebo capsules for 8 weeks
• Aerobic Exercise (AE)
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.
• Theobroma Cocoa (TC)
Daily consumption of 500mg cocoa in capsules for 8 weeks.

Locations

Country	Name	City	State
Brazil	Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Cardiologia do Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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