NCT03342599

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
Last Updated

November 17, 2017

Status Verified

March 1, 2017

Enrollment Period

2.9 years

First QC Date

February 6, 2015

Last Update Submit

November 8, 2017

Conditions

Metabolic SyndromeObesity

Keywords

Alpha Lipoic Acid

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Effects on oxygen consumption and carbon dioxide production at rest

    8 weeks

  • Effects on oxygen consumption and carbon dioxide production during exercise

    8 weeks

Study Arms (2)

GNC Alpha Lipoic Acid Supplement

EXPERIMENTAL

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

Dietary Supplement: Alpha Lipoic Acid Supplement

Cellulose Fiber Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Alpha Lipoic Acid SupplementDIETARY_SUPPLEMENT

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

GNC Alpha Lipoic Acid Supplement
PlaceboDIETARY_SUPPLEMENT

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

Cellulose Fiber Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Overweight or obese (body mass index 25 - 35 kg/m2)
  • Males (18-35 years)
  • Able to ingest supplement or placebo

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of La Verne Kinesiology Laboratory

La Verne, California, 91750, United States

Location

MeSH Terms

Conditions

Metabolic SyndromeObesity

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sarah L Dunn, Ph.D.

    University of La Verne Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Kinesiology

Study Record Dates

First Submitted

February 6, 2015

First Posted

November 17, 2017

Study Start

October 1, 2013

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

November 17, 2017

Record last verified: 2017-03

Locations

US(1)