Racial and Aging Effects of Acute Antioxidant Supplementation (RACE)

June 12, 2015 updated by: Bo Fernhall, University of Illinois at Chicago

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
93

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois - Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: 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.
Dietary supplement: Antioxidant
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
Other: Placebo
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
EXPERIMENTAL: 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.
Dietary supplement: Antioxidant
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
Other: Placebo
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 weeks
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
2 weeks
Endothelial function
Time Frame: 2 weeks
A third primary outcome is endothelial function assessed through brachial artery flow mediated dilation.
2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: 2 weeks
Both brachial and central blood pressure will be measured as secondary outcomes.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Illinois at Chicago

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bo Fernhall, Ph.D., University of Illinois at Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2013-0980

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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