Racial and Aging Effects of Acute Antioxidant Supplementation

NCT ID: NCT02157207

Last Updated: 2015-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-06-30

Brief Summary

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This research is,being done to better understand how antioxidants (vitamins C, E and Alpha Lipoic Acid) af,f,ect the heart,and arteries. For this study, we will obtain blood samples to measure oxidative stress markers (substances in the blood that are linked to oxidative stress), cholesterol, insulin and blood glucose (sugar), as well as measure how well the heart and arteries are working following supplementation with the antioxidants.

Our central hypothesis is that acute antioxidant supplementation will improve arterial function at rest and during exercise in African Americans without an impact of age, whereas aging will modify these effects in Caucasians.

Detailed Description

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The overall goal of this application is to investigate the effect of aging on how acute antioxidant supplementation affects decrements in arterial function observed in African Americans (AA). Additionally, this application will facilitate the applicant's emergence as an independent investigator in integrative clinical physiology. Oxidative stress (OS), contributes to hypertension, diabetes, heart failure, atherosclerosis, sepsis and aging. Increased OS leads to the development of endothelial dysfunction and subsequent development of cardiovascular disease through the inactivation of nitric oxide (NO) by superoxide (O2) and other free radicals. African Americans (AA) have increased OS and inflammation in vivo and in vitro, and have a lower serum concentration of most antioxidants. Endothelial cells of AAs have steady state NO/ O2/ONOO- balance that is close to redox state, which is a characteristic of endothelium impaired function disorders. Endothelium-derived NO is a vasodilator and inhibits monocyte adhesion and platelet activity and therefore is important in the maintenance of vascular homeostasis. These specific differences in OS could be a contributing mechanism to the high prevalence of cardiovascular disease, especially hypertension and heart failure, observed in AA. Aging causes increases in OS, endothelial dysfunction, and decreased arterial compliance, thus increasing the risk of cardiovascular disease. Acute supra-physiological dosages of antioxidants have been shown to transiently restore endothelial function in older adults and patients with coronary artery disease and hypertension by scavenging free radicals.However, it is unknown if acute antioxidant supplementation can diminish differences in vascular function between AA and Caucasians (CA). It is also unknown if acute antioxidant supplementation with known efficacy will differentially affect blood flow in AA vs CA during exercise.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Placebo will be ingested in front of laboratory personnel in two doses, separated by 30 minutes to increase absorption, consumed 90 and 60 minutes before the testing protocol. Placebo microcrystalline cellulose capsules will be of similar taste, color and appearance.

Group Type PLACEBO_COMPARATOR

Antioxidant

Intervention Type DIETARY_SUPPLEMENT

Comparison of antioxidant supplementation with a placebo. Effects of race and age and race in repsonse to the supplementation will be evaluated.

Placebo

Intervention Type OTHER

Comparison of antioxidant supplementation with a placebo. Effects of race and age and race in repsonse to the supplementation will be evaluated.

Antioxidant

Supplementation will be ingested in front of laboratory personnel in two doses, separated by 30 minutes to increase absorption, consumed 90 and 60 minutes before the testing protocol. The first dose will consist of 300 mg of α-lipoic acid, 500 mg of vitamin C, and 200 IU of vitamin E, and the second dose will be 300 mg of α-lipoic acid, 500 mg of vitamin C, and 400 IU.

of vitamin E.

Group Type EXPERIMENTAL

Antioxidant

Intervention Type DIETARY_SUPPLEMENT

Comparison of antioxidant supplementation with a placebo. Effects of race and age and race in repsonse to the supplementation will be evaluated.

Placebo

Intervention Type OTHER

Comparison of antioxidant supplementation with a placebo. Effects of race and age and race in repsonse to the supplementation will be evaluated.

Interventions

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Antioxidant

Comparison of antioxidant supplementation with a placebo. Effects of race and age and race in repsonse to the supplementation will be evaluated.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Comparison of antioxidant supplementation with a placebo. Effects of race and age and race in repsonse to the supplementation will be evaluated.

Intervention Type OTHER

Other Intervention Names

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Vitamin E, Vitamin C, α-lipoic acid No other names

Eligibility Criteria

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Inclusion Criteria

* 18-35 or 55-75 years of age
* General Good health
* Without diagnosed atherosclerotic disease
* Without metabolic or inflammatory disease
* Do not use antioxidant vitamin supplementation
* Do not use anti-inflammatory medication within last 2 weeks
* Do not use steroidal substances within past 2 weeks

Exclusion Criteria

* Current smoker
* Severe obesity (BMI\>40 kg/m2)
* Blood pressure greater than 140/90 mmHg
* Diabetes (fasting glucose \>110 mg/dl)
* Hyperlipidemia (total cholesterol \>240 mg/dl)
* Inflammatory disease (rheumatoid arthritis, systemic lupus erythematosus, etc)
* Diagnosed atherosclerotic heart disease
* Diagnosed cardiac arrhythmia
* Bacterial, viral or upper respiratory infection within past 1 month
* Bleeding disorder
* Anticoagulant medication
* Pregnant women
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

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Bo Fernhall

Dean

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bo Fernhall, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

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University of Illinois - Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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2013-0980

Identifier Type: -

Identifier Source: org_study_id

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