Effect of Cocoa Supplementation and Aerobic Exercise on Pressure Parameters
1 other identifier
interventional
84
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2021
CompletedFirst Posted
Study publicly available on registry
February 1, 2021
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2022
CompletedAugust 20, 2021
August 1, 2021
1 year
January 27, 2021
August 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
Control Group (CG)
PLACEBO COMPARATORThis group will receive placebo capsules to be consumed for 8 weeks daily and will not exercise;
Aerobic Exercise (AE)
ACTIVE COMPARATORThis 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.
Aerobic exercise + Theobroma cocoa (AETC)
EXPERIMENTALThis 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
Theobroma cocoa (TC)
EXPERIMENTALThis group will receive 500mg cocoa capsules to be consumed daily for 8 weeks.
Interventions
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.
Daily consumption of placebo capsules for 8 weeks
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.
Daily consumption of 500mg cocoa in capsules for 8 weeks.
Eligibility Criteria
You may qualify if:
- Sedentary lifestyle (IPAQ- International Physical Activity Questionnaire);
- Eutrophic or overweight (BMI \>18,5kg/m² and \<30kg/m²).
You may not qualify if:
- 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);
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia
Porto Alegre, Rio Grande do Sul, 90620001, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tainah Ortiz, M.Sc
Instituto de Cardiologia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2021
First Posted
February 1, 2021
Study Start
September 1, 2021
Primary Completion
September 1, 2022
Study Completion
December 10, 2022
Last Updated
August 20, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share