Effects of Oral Antioxidant Cocktail in Cardiovascular Disease Patients

NCT03629613 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-08-15

No results posted yet for this study

Summary

Title: Effects of oral antioxidant cocktail on vascular function and muscle function in cardiovascular disease patients

Cardiovascular disease (CVD) generally refers to various conditions involving narrowed or blocked dysfunctional blood vessels that often lead to heart attack or stroke. One of the main contributors to blood vessel dysfunction is damage to the vascular endothelium. This often results from the accumulation of oxidative stress (OS) and inflammation due to a decrease in blood flow and oxygen transport to the body's organs and skeletal muscle.

The body's natural antioxidant defense system cannot keep up with the high level of OS clearance necessary to maintain proper vascular homeostasis. Previous research has addressed the use of single antioxidants (e.g. vitamin E, beta-carotene, ascorbic acid) in CVD patients, but the use of a combination of antioxidants has yet to be examined. Therefore, the purpose of this study is to examine the effects of acute oral antioxidant cocktail administration (containing vitamin C, E, and alpha-lipoic acid) on oxidative stress, vascular function, autonomic function (heart rate variability), leg blood flow, leg muscle tissue oxygenation, and walking capacity in CVD patients.

This is a parallel study design that will assess the effects of oral antioxidant cocktail administration on CVD patients ages 50-85. Subjects will be required to visit the lab 1 time. This visit will consist of 1) obtaining informed consent and questions, 2) baseline blood sampling and baseline measurements of endothelial function, arterial stiffness, autonomic function (heart rate variability), leg blood flow, leg muscle oxygenation, and a walking test, 3) first dose oral antioxidant cocktail administration followed by a 2-hour break, 4) second dose oral antioxidant cocktail 30 minutes after the first dose, 5) post-consumption blood sampling and measurements of endothelial function, arterial stiffness, autonomic function (heart rate variability), leg blood flow, leg muscle oxygenation, and a walking test.

Conditions

Interventions

DIETARY_SUPPLEMENT

Oral antioxidant cocktail

Oral antioxidant cocktail intake will occur after baseline measurements: Dose 1 (immediately after baseline testing): 300 mg alpha-lipoic acid, 500 mg vitamin C, 200 IU vitamin E Dose 2 (30 minutes after Dose 1): 300 mg alpha-lipoic acid, 500 mg vitamin C, 400 IU vitamin E

OTHER

Baseline

No oral antioxidant cocktail intake or placebo intake will occur prior to baseline measurements

Sponsors & Collaborators

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Song-Young Park, PhD · University of Nebraska

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2022-09-13
Completion
2022-09-13

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03629613 on ClinicalTrials.gov