- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03342599
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Glucose Metabolism Disorders
- Metabolic Diseases
- Disease
- Body Weight
- Insulin Resistance
- Hyperinsulinism
- Syndrome
- Metabolic Syndrome
- Overweight
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Protective Agents
- Micronutrients
- Vitamins
- Antioxidants
- Vitamin B Complex
- Thioctic Acid
Other Study ID Numbers
- ULVALApilot-01
- ULV2013-CASIRB-24 (Other Identifier: University of La Verne)
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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