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

Obesity Clinical Trial

— ALA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03342599
• Other study ID #: ULVALApilot-01
• Secondary ID: ULV2013-CASIRB-2
• Status: Completed
• Phase: N/A
• First received: February 6, 2015
• Last updated: November 8, 2017
• Start date: October 2013
• Est. completion date: September 2016

Study information

• Verified date: March 2017
• Source: University of La Verne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity
• Overweight
• Syndrome

Intervention

Dietary Supplement:
• Alpha Lipoic Acid Supplement
Alpha lipoic acid ingestion (600mg/daily) for 8 weeks with no change in lifestyle.
• Placebo
Cellulose fiber ingestion (600mg/daily) for 8 weeks with no change in lifestyle.

Locations

Country	Name	City	State
United States	University of La Verne Kinesiology Laboratory	La Verne	California

Sponsors (1)

Lead Sponsor	Collaborator
University of La Verne

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects on whole blood fasting glucose	Measured by single drop cuvette of whole blood using Hemocue Glucose 201	8 weeks
Primary	Effects on fasting plasma inflammatory biomarkers	Measured by ELISA kit	8 weeks
Primary	Effects on body composition (body fat, muscle mass, body weight)	Measured by bioelectrical impedance using a Tanita floor scale	8 weeks
Secondary	Effects on oxygen consumption and carbon dioxide production at rest	Measured by True One Metabolic Cart by Parvomedics via hood	8 weeks
Secondary	Effects on oxygen consumption and carbon dioxide production during exercise	Measured by True One Metabolic Cart by Parvomedics via facemask	8 weeks