Racial and Aging Effects of Acute Antioxidant Supplementation

NCT02157207 | Completed DMC

• 1 other identifier: 2013-0980
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

antioxidants; Caucasians; healthy; African Americans; vascular; aging; racial differences

Outcome Measures

Primary Outcomes (3)

• Arterial stiffness

  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

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

  2 weeks

• Endothelial function

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

  2 weeks

Secondary Outcomes (1)

• Blood pressure

  2 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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; Other: Placebo

Antioxidant

EXPERIMENTAL

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; Other: Placebo

Interventions

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.

Also known as: Vitamin E, Vitamin C, α-lipoic acid

Antioxidant; Placebo

Placebo OTHER

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

Also known as: No other names

Antioxidant; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois - Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Interventions

Antioxidants; Vitamin E; Ascorbic Acid; Thioctic Acid

Intervention Hierarchy (Ancestors)

Biological Factors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Protective Agents; Physiological Effects of Drugs; Specialty Uses of Chemicals; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Officials

• Bo Fernhall, Ph.D.

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean

Study Record Dates

• First Submitted: June 1, 2014
• First Posted: June 5, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: June 1, 2015
• Last Updated: June 16, 2015

Record last verified: 2015-06

Locations

US (1)