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Acute Influence of Resveratrol Supplementation and Beet Extract in Recovery After Exercise in Coronary Paths

Primary Purpose

Coronary Artery Disease, Autonomic Nervous System Disease, Blood Pressure

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Placebo Protocol
Protocol Beet
Protocol Resveratrol
Protocol Beet and Resveratrol
Sponsored by
Universidade Estadual Paulista Júlio de Mesquita Filho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Coronary Artery Disease

Eligibility Criteria

40 Years - 79 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: adult men over 45 years of age diagnosed with ischemic coronary artery disease and with preserved left ventricular function (above 50%), confirmed by a previous echocardiogram Exclusion Criteria: Volunteers who present at least one of the following characteristics will be excluded: smokers alcohol drinkers those who did not attend a cardiovascular rehabilitation program for at least 3 months prior to data collection individuals who have known infections, metabolic and respiratory diseases that could interfere in cardiac autonomic control, unstable angina, uncontrolled hypertension, significant valvular disease, uncontrolled metabolic disease (e.g., uncontrolled diabetes and thyroid disease)

Sites / Locations

  • Universidade Estadual Paulista

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo Protocol

Protocol Beet

Protocol Resveratrol

Protocol Beet and Resveratrol

Arm Description

exercise and placebo capsules 500 mg (starch)

exercise and beet extract 500 mg

exercise and resveratrol capsules 500 mg

exercise and beet extract 500mg and resveratrol capsules 500 mg

Outcomes

Primary Outcome Measures

Heart rate variability (HRV)
Time and frequency domain of HRV

Secondary Outcome Measures

Blood Pressure
Systolic Blood Pressure and Diastolic Blood Pressure

Full Information

First Posted
October 4, 2023
Last Updated
October 18, 2023
Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
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1. Study Identification

Unique Protocol Identification Number
NCT06095635
Brief Title
Acute Influence of Resveratrol Supplementation and Beet Extract in Recovery After Exercise in Coronary Paths
Official Title
Acute Influence of Resveratrol Supplementation and Beet Extract in Recovery After Exercise Submaximal Aerobic in Coronary Paths: a Study Prospective, Randomized Placebo-controlled
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 10, 2022 (Actual)
Primary Completion Date
January 10, 2023 (Actual)
Study Completion Date
September 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Introduction: Most cardiovascular diseases (CVD) can be prevented and controlled by adopting lifestyle changes, such as regular physical exercise and nutrition. Resveratrol and beverage extract promote beneficial health effects due to their nutritional properties. Objective: to analyze the effects of resveratrol supplementation and withdrawal extract on post-exercise recovery in coronary heart disease patients. Methods: men diagnosed with ischemic coronary artery disease will undergo four exercise protocols consisting of 30 minutes of aerobic exercise on an ergometric treadmill, with 5 minutes of warm-up, intensity of 30% of the heart rate reserve (HRR), followed by 25 minutes at intensity 60% of FCR and for a final 30 minutes of recovery in the supine position. Before each exercise protocol, all volunteers will consume: 500 mg of placebo (starch), or 500 mg of beetroot, or 500 mg of resveratrol and will also consume resveratrol and drink (500 mg each) 30 minutes before exercise. , the order of each supplementation will be done randomly. Cardiorespiratory parameters and heart rate variability (HRV) will be assessed at different times throughout the experimental procedure. To analyze the moments (rest versus recovery), the Bonferroni post-test will be used for parametric distribution or the Dunn post-test for non-parametric distribution. Statistical significance will be calculated at 5% for all analyses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Autonomic Nervous System Disease, Blood Pressure, Heart Rate

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Protocol
Arm Type
Placebo Comparator
Arm Description
exercise and placebo capsules 500 mg (starch)
Arm Title
Protocol Beet
Arm Type
Experimental
Arm Description
exercise and beet extract 500 mg
Arm Title
Protocol Resveratrol
Arm Type
Experimental
Arm Description
exercise and resveratrol capsules 500 mg
Arm Title
Protocol Beet and Resveratrol
Arm Type
Experimental
Arm Description
exercise and beet extract 500mg and resveratrol capsules 500 mg
Intervention Type
Other
Intervention Name(s)
Placebo Protocol
Other Intervention Name(s)
500 mg of starch
Intervention Description
ingestion of 500 mg of starch following 30 minutes of exercise (treadmill)
Intervention Type
Other
Intervention Name(s)
Protocol Beet
Other Intervention Name(s)
500 mg of beet extract
Intervention Description
ingestion of 500 mg of beet extect following 30 minutes of exercise (treadmill)
Intervention Type
Other
Intervention Name(s)
Protocol Resveratrol
Other Intervention Name(s)
500 mg of resveratrol
Intervention Description
ingestion of 500 mg of resveratrol following 30 minutes of exercise (treadmill)
Intervention Type
Other
Intervention Name(s)
Protocol Beet and Resveratrol
Other Intervention Name(s)
500 mg of beet extect and 500 mg of resveratrol
Intervention Description
ingestion 500 mg of beet extect and 500 mg of resveratrol following 30 minutes of exercise (treadmill)
Primary Outcome Measure Information:
Title
Heart rate variability (HRV)
Description
Time and frequency domain of HRV
Time Frame
through study completion, an average of 1 hour
Secondary Outcome Measure Information:
Title
Blood Pressure
Description
Systolic Blood Pressure and Diastolic Blood Pressure
Time Frame
through study completion, an average of 1 hour

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult men over 45 years of age diagnosed with ischemic coronary artery disease and with preserved left ventricular function (above 50%), confirmed by a previous echocardiogram Exclusion Criteria: Volunteers who present at least one of the following characteristics will be excluded: smokers alcohol drinkers those who did not attend a cardiovascular rehabilitation program for at least 3 months prior to data collection individuals who have known infections, metabolic and respiratory diseases that could interfere in cardiac autonomic control, unstable angina, uncontrolled hypertension, significant valvular disease, uncontrolled metabolic disease (e.g., uncontrolled diabetes and thyroid disease)
Facility Information:
Facility Name
Universidade Estadual Paulista
City
Presidente Prudente
State/Province
São Paulo
ZIP/Postal Code
19060-900
Country
Brazil

12. IPD Sharing Statement

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Acute Influence of Resveratrol Supplementation and Beet Extract in Recovery After Exercise in Coronary Paths

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