Dose Ranging Study of the Effects of Alpha Lipoic Acid on Oxidative Stress

This study has been completed.
Sponsor:
Collaborator:
Jarrow Formulas Inc
Information provided by (Responsible Party):
Pamela Ouyang, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00857376
First received: March 4, 2009
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

Heart disease is the most common cause of death in the United States and it is commonly found in people with diabetes and high cholesterol. Inflammation is one mechanism by which diabetes and elevated cholesterol damage blood vessels. Inflammation can be increased by oxidative stress. This study will see if Alpha Lipoic acid, a potent antioxidant and over the counter product, reduces blood levels of markers of oxidative stress and inflammation when compared with placebo. Placebo is a substance that looks like the real product, but contains no active product.


Condition Intervention Phase
Metabolic Syndrome
Dietary Supplement: Alpha lipoic acid at 3 doses compared to placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: Dose Ranging Study of the Effects of Alpha Lipoic Acid on Oxidative Stress

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • This study will provide information on the effect of a dose range of ALA on oxidative stress biomarkers. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine whether ALA improves vascular function through its effects on oxidative stress [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 77
Study Start Date: March 2008
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
Placebo 2 tabs three times daily
Dietary Supplement: Alpha lipoic acid at 3 doses compared to placebo
This is a randomized study comparing the antioxidant effects of 3 doses of alpha lipoic acid (total of 600 mg daily, 1200 mg daily and 1800 mg daily) compared to placebo. These doses will be taken as 2 pills 3 times a day for 8 to 10 weeks.
Experimental: Alpha lipoic acid 1
Alpha lipoic acid 600 mg daily
Dietary Supplement: Alpha lipoic acid at 3 doses compared to placebo
This is a randomized study comparing the antioxidant effects of 3 doses of alpha lipoic acid (total of 600 mg daily, 1200 mg daily and 1800 mg daily) compared to placebo. These doses will be taken as 2 pills 3 times a day for 8 to 10 weeks.
Experimental: Alpha lipoic acid 2
Alpha Lipoic acid 1200 mg daily
Dietary Supplement: Alpha lipoic acid at 3 doses compared to placebo
This is a randomized study comparing the antioxidant effects of 3 doses of alpha lipoic acid (total of 600 mg daily, 1200 mg daily and 1800 mg daily) compared to placebo. These doses will be taken as 2 pills 3 times a day for 8 to 10 weeks.
Experimental: Alpha lipoic acid 3
Alpha lipoic acid 1800 mg daily
Dietary Supplement: Alpha lipoic acid at 3 doses compared to placebo
This is a randomized study comparing the antioxidant effects of 3 doses of alpha lipoic acid (total of 600 mg daily, 1200 mg daily and 1800 mg daily) compared to placebo. These doses will be taken as 2 pills 3 times a day for 8 to 10 weeks.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 40 or more yrs,
  • Are able to give informed consent
  • Diabetic on stable doses of oral medications or diet or
  • Metabolic syndrome defined as having 3 or more of the following:
  • Impaired or fasting glucose > or = 100 mg/dL) or impaired glucose tolerance
  • Waist circumference > 40 inches in men and > 35 inches in women,
  • Hypertension (> or = 130/85 mmHg) or are on antihypertensive medication,
  • LDL < or = 50 mg/dL in females and < or = 40 mg/dL in men,
  • Triglyceride > or = 150 mg/dL

Exclusion Criteria:

  • Are on oral hypoglycemic drugs or insulin with HbA1c > 7.5,if diabetic,
  • On antioxidant supplementation and are unable or unwilling to stop,
  • A woman on hormone replacement therapy,
  • On medications that may have antioxidant or anti-inflammatory effects or effects on insulin sensitivity, e.g. HMGCo-A reductase inhibitor that cannot be discontinued for the duration of the study,
  • Current smoker (within 3 months prior to enrollment),
  • Have known coronary artery disease or stroke,
  • Have other diseases associated with active inflammation e.g. connective tissue disease, malignancy,
  • have a CRP > or = 10 mg/dl on screening blood with clinical evidence of inflammation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857376

Sponsors and Collaborators
Johns Hopkins University
Jarrow Formulas Inc
Investigators
Principal Investigator: Pamela Ouyang, MBBS Johns Hopkins University
  More Information

No publications provided

Responsible Party: Pamela Ouyang, Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00857376     History of Changes
Other Study ID Numbers: NA00016646, Grant # 1R21 AT003862-01A2
Study First Received: March 4, 2009
Last Updated: September 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Heart disease risk factors
Risk factor management
Pre-Diabetes
Hypertension
obesity
glucose intolerance
high cholesterol
abdominal obesity
enlarged waist

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Thioctic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 26, 2014