Effects of Alpha Lipoic Acid Supplementation on Metabolic Syndrome Markers in Young Overweight or Obese Males (ALA)

November 8, 2017 updated by: Dr. Sarah L. Dunn, University of La Verne
Eight weeks supplementation of alpha lipoic acid (known superantioxidant already produced by the body) will significantly improve metabolic syndrome markers (e.g., excess body weight, blood pressure, glucose, insulin, blood lipids, and self-report measures) in young (18-25 years) overweight or obese males compared to placebo (cellulose starch). If the hypothesis is supported, alpha lipoic acid ingestion could be beneficial in reducing disease risk and enhancing metabolic dysfunction in ethnic individuals. Therefore, the purpose is to establish the impact alpha lipoic acid has on the modifiable markers associated with metabolic perturbations consistent with metabolic syndrome in males.

Study Overview

Detailed Description

Young adults exhibit an increasing prevalence of obesity, pre-diabetes, and metabolic syndrome that contribute to increased risk of type II diabetes and cardiovascular heart disease later in life. Twenty five percent of American adults have been diagnosed with metabolic syndrome, whereas the prevalence increases to 30 % in Mexican American adults between 30-70 years old. The risk in this population may be higher based on ethnicity and the rising obesity rates in young adults and children, although the definition of metabolic syndrome in younger age has yet to be established. Factors causing metabolic syndrome are complex but include a physically inactive lifestyle, an unhealthy diet made up of saturated fat and processed foods, and inherited influences. Therefore identifying the need to intervene early with a dietary intervention in order to combat the risk for future disease is vital. It is hypothesized that 8 weeks supplementation of alpha lipoic acid (known superantioxidant already produced by the body) will significantly improve metabolic syndrome markers (e.g., excess body weight, blood pressure, glucose, insulin, blood lipids, and self-report measures) in young (18-25 years) overweight or obese males compared to placebo (cellulose starch). If the hypothesis is supported, alpha lipoic acid ingestion could be beneficial in reducing disease risk and enhancing metabolic dysfunction in young individuals. Therefore, the purpose is to establish the impact alpha lipoic acid has on the modifiable markers associated with metabolic perturbations consistent with metabolic syndrome in males.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • 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

    • California
      • La Verne, California, United States, 91750
        • University of La Verne Kinesiology Laboratory

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

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Overweight or obese (body mass index 25 - 35 kg/m2)
  • Males (18-35 years)
  • Able to ingest supplement or placebo

Exclusion Criteria:

  • Female (due to menstrual cycle fluctuations)
  • Unable to read English at the time of consent
  • Have a body mass index under 25 kg/m2 or over 35 kg/m2
  • Diabetes
  • Impaired glucose tolerance (fasting plasma glucose levels >110 mg/dL
  • Hypertension (SBP>130mmHg or DBP>90mmHg)
  • Cardiovascular problems or disease
  • Psychiatric problems
  • History of alcohol abuse (intake of >500 g/wk in the last year)
  • Current or recent (in the past 3 years) smoking
  • Certain medication or dietary supplement use (medications or dietary supplements known to cause weight loss/gain or metabolic improvements/dysfunction. Paxil or (paroxetine), Prozac (fluoxetine), Remeron (mirtazapine), Zyprexa (olanzapine), Deltasone (prednisone), Thorazine (chlorpromazine), Elavil, Endep, Vanatrip (amitriptyline), Depakote (valproic acid), Allegra (fexofenadine and pseudoephedrine), Diabinese or Insulase
  • Symptoms of chronic or current infection
  • A chronic inflammatory condition
  • Any thyroid condition, and/or liver disease or malignancy

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GNC Alpha Lipoic Acid Supplement
600mg/daily ingestion of GNC alpha lipoic acid with no change in lifestyle for 8 weeks
Alpha lipoic acid ingestion (600mg/daily) for 8 weeks with no change in lifestyle.
Placebo Comparator: Cellulose Fiber Placebo
600mg/daily ingestion of Vital Nutrients placebo (cellulose starch) with no change in lifestyle for 8 weeks
Cellulose fiber ingestion (600mg/daily) for 8 weeks with no change in lifestyle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects on whole blood fasting glucose
Time Frame: 8 weeks
Measured by single drop cuvette of whole blood using Hemocue Glucose 201
8 weeks
Effects on fasting plasma inflammatory biomarkers
Time Frame: 8 weeks
Measured by ELISA kit
8 weeks
Effects on body composition (body fat, muscle mass, body weight)
Time Frame: 8 weeks
Measured by bioelectrical impedance using a Tanita floor scale
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects on oxygen consumption and carbon dioxide production at rest
Time Frame: 8 weeks
Measured by True One Metabolic Cart by Parvomedics via hood
8 weeks
Effects on oxygen consumption and carbon dioxide production during exercise
Time Frame: 8 weeks
Measured by True One Metabolic Cart by Parvomedics via facemask
8 weeks

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Sarah L Dunn, Ph.D., University of La Verne Assistant Professor

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

October 1, 2013

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

February 6, 2015

First Submitted That Met QC Criteria

November 8, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

November 17, 2017

Last Update Submitted That Met QC Criteria

November 8, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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