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Antioxidant Functions of Lipoic Acid

NCT ID: NCT00065624

Last Updated: 2007-10-02

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

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2007-07-31

Brief Summary

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The goal of this study is to determine whether a short treatment with lipoic acid, an antioxidant used in the treatment of diabetic neuropathy, improves blood vessel reactivity and decreases oxidant stress in persons with elevated blood cholesterol.

Detailed Description

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As per Brief Summary

Conditions

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Hypercholesterolemia

Keywords

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Lipoic acid F2-isoprostanes endothelial dysfunction natural product

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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lipoic acid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Lipid criteria for inclusion are a plasma LDL between 160 and 190 mg/dl (total cholesterol usually 240-285 mg/dl)
* Less than 2 coronary risk factors, and already on a cholesterol-lowering diet.

Exclusion Criteria

* Overt or clinical atherosclerosis
* Diabetes
* Currently taking cholesterol-lowering medication.
* Subjects with other lipid disorders
* Subjects taking supplemental lipoic acid, vitamin C, or vitamin E.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role lead

Principal Investigators

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James M May, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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R21AT001062-01A2

Identifier Type: NIH

Identifier Source: org_study_id

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