search
Back to results

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

Primary Purpose

Metabolic Syndrome, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alpha Lipoic Acid Supplement
Placebo
Sponsored by
University of La Verne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metabolic Syndrome focused on measuring Alpha Lipoic Acid

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts 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

Sites / Locations

  • University of La Verne Kinesiology Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GNC Alpha Lipoic Acid Supplement

Cellulose Fiber Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Effects on whole blood fasting glucose
Measured by single drop cuvette of whole blood using Hemocue Glucose 201
Effects on fasting plasma inflammatory biomarkers
Measured by ELISA kit
Effects on body composition (body fat, muscle mass, body weight)
Measured by bioelectrical impedance using a Tanita floor scale

Secondary Outcome Measures

Effects on oxygen consumption and carbon dioxide production at rest
Measured by True One Metabolic Cart by Parvomedics via hood
Effects on oxygen consumption and carbon dioxide production during exercise
Measured by True One Metabolic Cart by Parvomedics via facemask

Full Information

First Posted
February 6, 2015
Last Updated
November 8, 2017
Sponsor
University of La Verne
search

1. Study Identification

Unique Protocol Identification Number
NCT03342599
Brief Title
Effects of Alpha Lipoic Acid Supplementation on Metabolic Syndrome Markers in Young Overweight or Obese Males
Acronym
ALA
Official Title
Effects of Alpha Lipoic Acid Supplementation on Metabolic Syndrome Markers in Young Overweight or Obese Males
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of La Verne

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Obesity
Keywords
Alpha Lipoic Acid

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GNC Alpha Lipoic Acid Supplement
Arm Type
Experimental
Arm Description
600mg/daily ingestion of GNC alpha lipoic acid with no change in lifestyle for 8 weeks
Arm Title
Cellulose Fiber Placebo
Arm Type
Placebo Comparator
Arm Description
600mg/daily ingestion of Vital Nutrients placebo (cellulose starch) with no change in lifestyle for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Alpha Lipoic Acid Supplement
Intervention Description
Alpha lipoic acid ingestion (600mg/daily) for 8 weeks with no change in lifestyle.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Cellulose fiber ingestion (600mg/daily) for 8 weeks with no change in lifestyle.
Primary Outcome Measure Information:
Title
Effects on whole blood fasting glucose
Description
Measured by single drop cuvette of whole blood using Hemocue Glucose 201
Time Frame
8 weeks
Title
Effects on fasting plasma inflammatory biomarkers
Description
Measured by ELISA kit
Time Frame
8 weeks
Title
Effects on body composition (body fat, muscle mass, body weight)
Description
Measured by bioelectrical impedance using a Tanita floor scale
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Effects on oxygen consumption and carbon dioxide production at rest
Description
Measured by True One Metabolic Cart by Parvomedics via hood
Time Frame
8 weeks
Title
Effects on oxygen consumption and carbon dioxide production during exercise
Description
Measured by True One Metabolic Cart by Parvomedics via facemask
Time Frame
8 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah L Dunn, Ph.D.
Organizational Affiliation
University of La Verne Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of La Verne Kinesiology Laboratory
City
La Verne
State/Province
California
ZIP/Postal Code
91750
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs