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

NCT ID: NCT03342599

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-09-30

Brief Summary

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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

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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.

Conditions

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Metabolic Syndrome Obesity

Keywords

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Alpha Lipoic Acid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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GNC Alpha Lipoic Acid Supplement

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

Group Type EXPERIMENTAL

Alpha Lipoic Acid Supplement

Intervention Type DIETARY_SUPPLEMENT

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

Cellulose Fiber Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Alpha Lipoic Acid Supplement

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of La Verne

OTHER

Sponsor Role lead

Responsible Party

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Dr. Sarah L. Dunn

Associate Professor of Kinesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sarah L Dunn, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of La Verne Assistant Professor

Locations

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University of La Verne Kinesiology Laboratory

La Verne, California, United States

Site Status

Countries

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United States

Other Identifiers

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ULV2013-CASIRB-24

Identifier Type: OTHER

Identifier Source: secondary_id

ULVALApilot-01

Identifier Type: -

Identifier Source: org_study_id