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

Not Applicable
Completed
Conditions
Metabolic Syndrome
Obesity
Interventions
Dietary Supplement: Placebo
Dietary Supplement: Alpha Lipoic Acid Supplement
Registration Number
NCT03342599
Lead Sponsor
University of La Verne
Brief Summary

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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
16
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Cellulose Fiber PlaceboPlacebo600mg/daily ingestion of Vital Nutrients placebo (cellulose starch) with no change in lifestyle for 8 weeks
GNC Alpha Lipoic Acid SupplementAlpha Lipoic Acid Supplement600mg/daily ingestion of GNC alpha lipoic acid with no change in lifestyle for 8 weeks
Primary Outcome Measures
NameTimeMethod
Effects on whole blood fasting glucose8 weeks

Measured by single drop cuvette of whole blood using Hemocue Glucose 201

Effects on fasting plasma inflammatory biomarkers8 weeks

Measured by ELISA kit

Effects on body composition (body fat, muscle mass, body weight)8 weeks

Measured by bioelectrical impedance using a Tanita floor scale

Secondary Outcome Measures
NameTimeMethod
Effects on oxygen consumption and carbon dioxide production at rest8 weeks

Measured by True One Metabolic Cart by Parvomedics via hood

Effects on oxygen consumption and carbon dioxide production during exercise8 weeks

Measured by True One Metabolic Cart by Parvomedics via facemask

Trial Locations

Locations (1)

University of La Verne Kinesiology Laboratory

🇺🇸

La Verne, California, United States

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