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OpenTrials
Completed

NCT Number: NCT02157207

Racial and Aging Effects of Acute Antioxidant Supplementation

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois - Chicago

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • Participants on medications (not listed in the Exclusion Criteria) will take medication as normal on all days of study visits.

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

Treatment and study plan

Antioxidant

Dietary Supplement

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

Other names: Vitamin E, Vitamin C, α-lipoic acid

Placebo

Other

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

Other names: No other names

Primary outcomes

  1. Arterial stiffness

    Time frame: 2 weeks

    The overall aim of this study is to examine the effects of an acute dose of an antioxidant cocktail on arterial stiffness (measured by ventral pulse wave velocity) in younger and older African Americans in comparison to younger and older Caucasians.

  2. Arm blood flow

    Time frame: 2 weeks

    A second primary outcome is arm blood flow at rest and during two different intensities of hand grip exercise

  3. Endothelial function

    Time frame: 2 weeks

    A third primary outcome is endothelial function assessed through brachial artery flow mediated dilation.

Secondary outcomes

  1. Blood pressure

    Time frame: 2 weeks

    Both brachial and central blood pressure will be measured as secondary outcomes.

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Acronym: RACE

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Jun 5, 2014
Registry last updated
Jun 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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