Metabolic SyndromeALANCT03342599
Effects of Alpha Lipoic Acid Supplementation on Metabolic Syndrome Markers in Young Overweight or Obese Males
A study testing Alpha Lipoic Acid Supplement in people with Metabolic Syndrome and Obesity, run by University of La Verne at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Obesity
- What is being tested?
- Alpha Lipoic Acid Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Overweight or obese (body mass index 25 - 35 kg/m2)
- Males (18-35 years)
- Able to ingest supplement or placebo
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of La Verne Kinesiology Laboratory
La Verne, California, 91750
About this study
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.
Read the 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.
- Conditions
- Metabolic Syndrome, Obesity
- Being tested
- Alpha Lipoic Acid Supplement, Placebo
- Keywords
- Alpha Lipoic Acid
- Medical subject headings
- Metabolic Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha Lipoic Acid SupplementDietary supplement
Alpha lipoic acid ingestion (600mg/daily) for 8 weeks with no change in lifestyle.
PlaceboDietary supplement
Cellulose fiber ingestion (600mg/daily) for 8 weeks with no change in lifestyle.
| Study group | Role | What they receive |
|---|---|---|
| GNC Alpha Lipoic Acid Supplement | Experimental | 600mg/daily ingestion of GNC alpha lipoic acid with no change in lifestyle for 8 weeks Receives: 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 Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects on whole blood fasting glucose
Measured by single drop cuvette of whole blood using Hemocue Glucose 201
Measured: 8 weeks
Effects on fasting plasma inflammatory biomarkers
Measured by ELISA kit
Measured: 8 weeks
Effects on body composition (body fat, muscle mass, body weight)
Measured by bioelectrical impedance using a Tanita floor scale
Measured: 8 weeks
Secondary outcomes (2)
Effects on oxygen consumption and carbon dioxide production at rest
Measured by True One Metabolic Cart by Parvomedics via hood
Measured: 8 weeks
Effects on oxygen consumption and carbon dioxide production during exercise
Measured by True One Metabolic Cart by Parvomedics via facemask
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study startOct 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of La Verne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sarah L. Dunn, University of La Verne
- Investigators
- Sarah L Dunn, Ph.D., Principal investigator, University of La Verne Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03342599
- Sponsor's protocol ID
- ULVALApilot-01
- Other IDs
- ULV2013-CASIRB-24
- Acronym
- ALA
- Status last verified
- Mar 2017
- First submitted
- 6 Feb 2015
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Alpha Lipoic Acid Supplementation on Metabolic Syndrome Markers in Young Overweight or Obese Males
- ClinicalTrials.gov ID
- NCT03342599
- Acronym / sponsor ID
- ALA / ULVALApilot-01
- Conditions
- Metabolic Syndrome, Obesity
- Keywords
- Alpha Lipoic Acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of La VerneUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GNC Alpha Lipoic Acid Supplement | Experimental | Dietary Supplement: Alpha Lipoic Acid Supplement600mg/daily ingestion of GNC alpha lipoic acid with no change in lifestyle for 8 weeks |
| Cellulose Fiber Placebo | Placebo comparator | Dietary Supplement: Placebo600mg/daily ingestion of Vital Nutrients placebo (cellulose starch) with no change in lifestyle for 8 weeks |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Overweight or obese (body mass index 25 - 35 kg/m2)
- Males (18-35 years)
- Able to ingest supplement or placebo
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha Lipoic Acid SupplementAlpha lipoic acid ingestion (600mg/daily) for 8 weeks with no change in lifestyle. | Dietary supplement | GNC Alpha Lipoic Acid Supplement |
| PlaceboCellulose fiber ingestion (600mg/daily) for 8 weeks with no change in lifestyle. | Dietary supplement | Cellulose Fiber Placebo |
Primary outcome
Effects on whole blood fasting glucose
Time frame: 8 weeks
Measured by single drop cuvette of whole blood using Hemocue Glucose 201
Effects on fasting plasma inflammatory biomarkers
Time frame: 8 weeks
Measured by ELISA kit
Effects on body composition (body fat, muscle mass, body weight)
Time frame: 8 weeks
Measured by bioelectrical impedance using a Tanita floor scale
2 secondary outcomes
Effects on oxygen consumption and carbon dioxide production at rest
Time frame: 8 weeks
Effects on oxygen consumption and carbon dioxide production during exercise
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah L Dunn, Ph.D. principal investigator
University of La Verne Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alpha Lipoic Acid Supplement in people with Metabolic Syndrome and Obesity, run by University of La Verne at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects on whole blood fasting glucose (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017; AzTrials last refreshed its copy on 8 Nov 2026.