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

NCT06095635 | Completed

• 1 other identifier: UEPJMG
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Autonomic Nervous System Disease; Blood Pressure; Heart Rate

Outcome Measures

Primary Outcomes (1)

• Heart rate variability (HRV)

  Time and frequency domain of HRV

  through study completion, an average of 1 hour

Secondary Outcomes (1)

• Blood Pressure

  through study completion, an average of 1 hour

Study Arms (4)

Placebo Protocol

PLACEBO COMPARATOR

exercise and placebo capsules 500 mg (starch)

Other: Placebo Protocol

Protocol Beet

EXPERIMENTAL

exercise and beet extract 500 mg

Other: Protocol Beet

Protocol Resveratrol

EXPERIMENTAL

exercise and resveratrol capsules 500 mg

Other: Protocol Resveratrol

Protocol Beet and Resveratrol

EXPERIMENTAL

exercise and beet extract 500mg and resveratrol capsules 500 mg

Other: Protocol Beet and Resveratrol

Interventions

Placebo Protocol OTHER

ingestion of 500 mg of starch following 30 minutes of exercise (treadmill)

Also known as: 500 mg of starch

Placebo Protocol

Protocol Beet OTHER

ingestion of 500 mg of beet extect following 30 minutes of exercise (treadmill)

Also known as: 500 mg of beet extract

Protocol Beet

Protocol Resveratrol OTHER

ingestion of 500 mg of resveratrol following 30 minutes of exercise (treadmill)

Also known as: 500 mg of resveratrol

Protocol Resveratrol

Protocol Beet and Resveratrol OTHER

ingestion 500 mg of beet extect and 500 mg of resveratrol following 30 minutes of exercise (treadmill)

Also known as: 500 mg of beet extect and 500 mg of resveratrol

Protocol Beet and Resveratrol

Eligibility Criteria

• Age: 40 Years - 79 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universidade Estadual Paulista Júlio de Mesquita Filho: lead

Study Sites (1)

Universidade Estadual Paulista

Presidente Prudente, São Paulo, 19060-900, Brazil

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Starch; Sucrose; Resveratrol

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides; Disaccharides; Oligosaccharides; Sugars; Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 23, 2023
• Study Start: March 10, 2022
• Primary Completion: January 10, 2023
• Study Completion: September 30, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

BR (1)