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

Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho (Other)
Overall Status
Completed
CT.gov ID
NCT06095635
Collaborator
(none)
17
Enrollment
1
Location
4
Arms
18.7
Actual Duration (Months)
0.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Placebo Protocol
  • Other: Protocol Beet
  • Other: Protocol Resveratrol
  • Other: Protocol Beet and Resveratrol
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
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
Actual Study Start Date :
Mar 10, 2022
Actual Primary Completion Date :
Jan 10, 2023
Actual Study Completion Date :
Sep 30, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Heart rate variability (HRV) [through study completion, an average of 1 hour]

      Time and frequency domain of HRV

    Secondary Outcome Measures

    1. Blood Pressure [through study completion, an average of 1 hour]

      Systolic Blood Pressure and Diastolic Blood Pressure

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 79 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universidade Estadual Paulista Presidente Prudente São Paulo Brazil 19060-900

    Sponsors and Collaborators

    • Universidade Estadual Paulista Júlio de Mesquita Filho

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Luana Almeida Gonzaga, MD, Universidade Estadual Paulista Júlio de Mesquita Filho
    ClinicalTrials.gov Identifier:
    NCT06095635
    Other Study ID Numbers:
    • UEPJMG
    First Posted:
    Oct 23, 2023
    Last Update Posted:
    Oct 23, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Nervous System Diseases
    Autonomic Nervous System Diseases
    Primary Dysautonomias
    Coronary Artery Disease
    Resveratrol

    Study Results

    No Results Posted as of Oct 23, 2023