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

Study Overview
=================
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.

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

Conditions
-----------------
Metabolic Syndrome, Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: Alpha Lipoic Acid Supplement
* Dietary Supplement: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GNC Alpha Lipoic Acid Supplement<br>600mg/daily ingestion of GNC alpha lipoic acid with no change in lifestyle for 8 weeks | Dietary Supplement: Alpha Lipoic Acid Supplement<br>* Alpha lipoic acid ingestion (600mg/daily) for 8 weeks with no change in lifestyle.<br>|
| Placebo Comparator: Cellulose Fiber Placebo<br>600mg/daily ingestion of Vital Nutrients placebo (cellulose starch) with no change in lifestyle for 8 weeks | Dietary Supplement: Placebo<br>* Cellulose fiber ingestion (600mg/daily) for 8 weeks with no change in lifestyle.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on whole blood fasting glucose | Measured by single drop cuvette of whole blood using Hemocue Glucose 201 | 8 weeks | 
| Effects on fasting plasma inflammatory biomarkers | Measured by ELISA kit | 8 weeks | 
| Effects on body composition (body fat, muscle mass, body weight) | 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 | Measured by True One Metabolic Cart by Parvomedics via hood | 8 weeks | 
| Effects on oxygen consumption and carbon dioxide production during exercise | Measured by True One Metabolic Cart by Parvomedics via facemask | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alpha Lipoic Acid