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

October 18, 2023 updated by: Luana Almeida Gonzaga, Universidade Estadual Paulista Júlio de Mesquita Filho

Acute Influence of Resveratrol Supplementation and Beet Extract in Recovery After Exercise Submaximal Aerobic in Coronary Paths: a Study Prospective, Randomized Placebo-controlled

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Presidente Prudente, São Paulo, Brazil, 19060-900
        • Universidade Estadual Paulista

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Protocol
exercise and placebo capsules 500 mg (starch)
Other: Placebo Protocol
ingestion of 500 mg of starch following 30 minutes of exercise (treadmill)
Other Names:
  • 500 mg of starch
Experimental: Protocol Beet
exercise and beet extract 500 mg
Other: Protocol Beet
ingestion of 500 mg of beet extect following 30 minutes of exercise (treadmill)
Other Names:
  • 500 mg of beet extract
Experimental: Protocol Resveratrol
exercise and resveratrol capsules 500 mg
Other: Protocol Resveratrol
ingestion of 500 mg of resveratrol following 30 minutes of exercise (treadmill)
Other Names:
  • 500 mg of resveratrol
Experimental: Protocol Beet and Resveratrol
exercise and beet extract 500mg and resveratrol capsules 500 mg
Other: Protocol Beet and Resveratrol
ingestion 500 mg of beet extect and 500 mg of resveratrol following 30 minutes of exercise (treadmill)
Other Names:
  • 500 mg of beet extect and 500 mg of resveratrol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate variability (HRV)
Time Frame: through study completion, an average of 1 hour
Time and frequency domain of HRV
through study completion, an average of 1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure
Time Frame: through study completion, an average of 1 hour
Systolic Blood Pressure and Diastolic Blood Pressure
through study completion, an average of 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2022

Primary Completion (Actual)

January 10, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

October 4, 2023

First Submitted That Met QC Criteria

October 18, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UEPJMG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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