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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06095635
• Other study ID #: UEPJMG
• Status: Completed
• Phase: N/A
• Start date: March 10, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2023
• Source: Universidade Estadual Paulista Júlio de Mesquita Filho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 30, 2023
• Est. primary completion date: January 10, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 79 Years

Eligibility

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)

Related Conditions & MeSH terms

• Autonomic Nervous System Disease
• Autonomic Nervous System Diseases
• Blood Pressure
• Coronary Artery Disease
• Heart Rate
• Nervous System Diseases
• Primary Dysautonomias

Intervention

Other:
• Placebo Protocol
ingestion of 500 mg of starch following 30 minutes of exercise (treadmill)
• Protocol Beet
ingestion of 500 mg of beet extect following 30 minutes of exercise (treadmill)
• Protocol Resveratrol
ingestion of 500 mg of resveratrol following 30 minutes of exercise (treadmill)
• Protocol Beet and Resveratrol
ingestion 500 mg of beet extect and 500 mg of resveratrol following 30 minutes of exercise (treadmill)

Locations

Country	Name	City	State
Brazil	Universidade Estadual Paulista	Presidente Prudente	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Estadual Paulista Júlio de Mesquita Filho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate variability (HRV)	Time and frequency domain of HRV	through study completion, an average of 1 hour
Secondary	Blood Pressure	Systolic Blood Pressure and Diastolic Blood Pressure	through study completion, an average of 1 hour