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

U

University of La Verne

Status

Completed

Conditions

Obesity
Metabolic Syndrome

Treatments

Dietary Supplement: Placebo
Dietary Supplement: Alpha Lipoic Acid Supplement

Study type

Interventional

Funder types

Other

Identifiers

NCT03342599
ULV2013-CASIRB-24 (Other Identifier)
ULVALApilot-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

Male

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

16 participants in 2 patient groups, including a placebo group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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