Effects of Oral Antioxidant Cocktail in Cardiovascular Disease Patients

NCT03629613 | Withdrawn

• 1 other identifier: 0557-18-FB
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Endothelial function

  Flow-mediated dilation will be used to measure endothelial function in the brachial artery. This will be done pre- and post-antioxidant intake.

  20 minutes

Secondary Outcomes (6)

• Arterial stiffness

  10 minutes

• Blood flow

  10 minutes

• Oxidative stress

  5 minutes

• Autonomic function

  40 minutes

• Muscle tissue oxygenation

  28 minutes (during physical walking capacity test)

Study Arms (2)

Baseline

SHAM COMPARATOR

Subjects will be tested on one day. Baseline testing will take place and will be followed by oral antioxidant cocktail intake. Oral antioxidant cocktail testing will take place \~2 hours after antioxidant intake. During baseline testing, no supplement or placebo intake will be used.

Other: Baseline

Oral antioxidant cocktail

EXPERIMENTAL

Subjects will be tested on one day. Baseline testing will take place and will be followed by oral antioxidant cocktail intake. Oral antioxidant cocktail testing will take place \~2 hours after antioxidant intake. Dose 1:(immediately after baseline) 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

Dietary Supplement: Oral antioxidant cocktail

Interventions

Oral antioxidant cocktail DIETARY_SUPPLEMENT

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

Oral antioxidant cocktail

Baseline OTHER

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

Baseline

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be able to give written, informed consent
• be diagnosed with CVD
• be between 50-85 years old
• be postmenopausal, meaning having had cessation of menses for at least 12 consecutive months
• be able to give written, informed consent
• no CVD conditions
• be between 50-85 years old
• be postmenopausal, meaning having had cessation of menses for at least 12 consecutive months

You may not qualify if:

• chronic kidney/renal disease
• chronic heart failure
• neuromuscular disease
• known cancer
• already supplementing with antioxidants or vitamins within 5 days of the study
• pregnant or nursing women

Sponsors & Collaborators

• University of Nebraska: lead

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MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

BaseLine dental cement

Study Officials

• Song-Young Park, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cardiovascular disease condition; healthy, age-matched control

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: August 14, 2018
• Study Start: December 1, 2020
• Primary Completion: September 13, 2022
• Study Completion: September 13, 2022
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share