Sedentary BehaviorNCT04732754
Effect of Cocoa Supplementation and Aerobic Exercise on Pressure Parameters
A study testing Aerobic exercise + Theobroma cocoa (AETC), Aerobic Exercise (AE) and Theobroma Cocoa (TC) in people with Sedentary Behavior, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior
- What is being tested?
- Aerobic exercise + Theobroma cocoa (AETC), Aerobic Exercise (AE) and Theobroma Cocoa (TC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2021to 10 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sedentary lifestyle (IPAQ- International Physical Activity Questionnaire);
- Eutrophic or overweight (BMI >18,5kg/m² and <30kg/m²).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia
Porto Alegre, Rio Grande do Sul, 90620001
About this study
Official title: Effect of Cocoa Supplementation and Aerobic Exercise on Central Pressure and Arterial Stiffness Parameters in Physically Inactive Middle-aged Individuals
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.
Read the 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.
- Conditions
- Sedentary Behavior
- Being tested
- Aerobic exercise + Theobroma cocoa (AETC), Control Group (CG), Aerobic Exercise (AE), Theobroma Cocoa (TC)
- Keywords
- Flavonoids, Cocoa, Arterial Stiffness, Physical Exercise, Central blood pressure
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise + Theobroma cocoa (AETC)Dietary supplement
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)Dietary supplement
Daily consumption of placebo capsules for 8 weeks
Aerobic Exercise (AE)Dietary supplement
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)Dietary supplement
Daily consumption of 500mg cocoa in capsules for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (CG) | Placebo comparator | This group will receive placebo capsules to be consumed for 8 weeks daily and will not exercise; Receives: Dietary Supplement: Control Group (CG) |
| Aerobic Exercise (AE) | Active comparator | 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. Receives: Dietary Supplement: Aerobic Exercise (AE) |
| Aerobic exercise + Theobroma cocoa (AETC) | Experimental | 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 Receives: Dietary Supplement: Aerobic exercise + Theobroma cocoa (AETC) |
| Theobroma cocoa (TC) | Experimental | This group will receive 500mg cocoa capsules to be consumed daily for 8 weeks. Receives: Dietary Supplement: Theobroma Cocoa (TC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start1 Sep 2021 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion10 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tainah Ortiz, M.Sc, Principal investigator, Instituto de Cardiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732754
- Sponsor's protocol ID
- UP 5839.20
- Status last verified
- Aug 2021
- First submitted
- 27 Jan 2021
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cocoa Supplementation and Aerobic Exercise on Central Pressure and Arterial Stiffness Parameters in Physically Inactive Middle-aged Individuals
- ClinicalTrials.gov ID
- NCT04732754
- Acronym / sponsor ID
- UP 5839.20
- Conditions
- Sedentary Behavior
- Keywords
- Flavonoids, Cocoa, Arterial Stiffness, Physical Exercise, Central blood pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 10 Dec 2022 (estimated)
- First posted
- 1 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Group (CG) | Placebo comparator | Dietary Supplement: Control Group (CG)This group will receive placebo capsules to be consumed for 8 weeks daily and will not exercise; |
| Aerobic Exercise (AE) | Active comparator | Dietary Supplement: Aerobic Exercise (AE)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. |
| Aerobic exercise + Theobroma cocoa (AETC) | Experimental | Dietary Supplement: Aerobic exercise + Theobroma cocoa (AETC)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 |
| Theobroma cocoa (TC) | Experimental | Dietary Supplement: Theobroma Cocoa (TC)This group will receive 500mg cocoa capsules to be consumed daily for 8 weeks. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Sedentary lifestyle (IPAQ- International Physical Activity Questionnaire);
- Eutrophic or overweight (BMI >18,5kg/m² and <30kg/m²).
Key exclusion criteria (6 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Aerobic exercise + Theobroma cocoa (AETC) |
| Control Group (CG)Daily consumption of placebo capsules for 8 weeks | Dietary supplement | Control Group (CG) |
| 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. | Dietary supplement | Aerobic Exercise (AE) |
| Theobroma Cocoa (TC)Daily consumption of 500mg cocoa in capsules for 8 weeks. | Dietary supplement | Theobroma cocoa (TC) |
Primary outcome
Arterial Stiffness by Pulse Wave Velocity
Time frame: 8 weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tainah Ortiz, M.Sc principal investigator
Instituto de Cardiologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise + Theobroma cocoa (AETC), Aerobic Exercise (AE) and Theobroma Cocoa (TC) in people with Sedentary Behavior, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tainah Ortiz, M.Sc (55 51 999171990, tainahortiz05@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial Stiffness by Pulse Wave Velocity (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2021.