Trial | NCT03342599  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    16
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.
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 Started
Oct 31
2013
Primary Completion
Sep 30
2016
Study Completion
Sep 30
2016
Last Update
Nov 17
2017

Dietary Supplement Alpha Lipoic Acid Supplement

Alpha lipoic acid ingestion (600mg/daily) for 8 weeks with no change in lifestyle.

Dietary Supplement Placebo

Cellulose fiber ingestion (600mg/daily) for 8 weeks with no change in lifestyle.

GNC Alpha Lipoic Acid Supplement Experimental

600mg/daily ingestion of GNC alpha lipoic acid with no change in lifestyle for 8 weeks

Cellulose Fiber Placebo Placebo Comparator

600mg/daily ingestion of Vital Nutrients placebo (cellulose starch) with no change in lifestyle for 8 weeks

Criteria 

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
No Results Posted