Clinical trial NCT03342599: Effects of Alpha Lipoic Acid Supplementation on Metabolic Syndrome Markers in Young Overweight or Obese Males
Official title: Effects of Alpha Lipoic Acid Supplementation on Metabolic Syndrome Markers in Young Overweight or Obese Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Obesity
Keywords: Alpha Lipoic Acid
Lead sponsor: University of La Verne
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Effects on whole blood fasting glucose
timeFrame: 8 weeks
measure: Effects on fasting plasma inflammatory biomarkers
timeFrame: 8 weeks
measure: Effects on body composition (body fat, muscle mass, body weight)
timeFrame: 8 weeks
Secondary outcomes:
measure: Effects on oxygen consumption and carbon dioxide production at rest
timeFrame: 8 weeks
measure: Effects on oxygen consumption and carbon dioxide production during exercise
timeFrame: 8 weeks
Other outcomes:
Locations:
city: La Verne
country: United States
facility: University of La Verne Kinesiology Laboratory
state: California
Study officials:
affiliation: University of La Verne Assistant Professor
name: Sarah L Dunn, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: