Impact of Alpha-Lipoic Acid Ingestion on Glucose Tolerance in Subjects With Pre-Diabetes

November 27, 2020 updated by: Todd Rideout, State University of New York at Buffalo

Obesity, with a prevalence of over 35% in American adults, is considered the most critical threat to the health and well-being of Americans. Obesity-associated metabolic abnormalities, including hyperglycemia, insulin resistance, and dyslipidemia, contribute substantially to elevated risk of cardiovascular disease (CVD) and diabetes. Although significant and sustained lifestyle modifications in diet and exercise are effective in reducing weight and improving obesity-related metabolic disturbances, long-term compliance to drastic changes in diet and daily activity patterns is often difficult to attain given the hectic lifestyle of modern societies. Health-promoting nutraceuticals - naturally occurring bioactive compounds capable of eliciting targeted molecular responses at the cellular level - may be an effective and convenient strategy to assist in weight reduction and reduce disease risk factors in obese individuals. Furthermore, nutraceutical compounds could prove to be a powerful adjunct to lifestyle and pharmacological weight reduction therapies, as they are relatively safe, cost effective, and possess the ability to modulate specific, and sometimes multiple, molecular targets. As a dietary supplement, alpha-lipoic acid appears to have broad molecular specificity with an impressive array of metabolic health benefits that include weight loss, reduction in blood lipids, and improved glycemic control. As the effects of alpha-lipoic acid supplementation for dyslipidemia, hyperglycemia, and body composition through appetite suppression and increased energy expenditure have been repeatedly confirmed in multiple animal models, it is surprising that there has been limited effort to translate these responses to human subjects. Given the strong pre-clinical data supporting the health benefits of alpha-lipoic acid, there is a clear need to conduct controlled interventions to address the current clinical knowledge gap and assess if the anti-diabetic effect of α-lipoic acid can be translated to humans.

The primary objective of this application is to determine the efficacy of alpha-lipoic acid supplementation on glycemic control and body composition in obese pre-diabetic adults. The investigators hypothesize that alpha-lipoic acid supplementation will improve biomarkers of diabetes and cardiovascular risk and promote changes in body composition in obese adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • sedentary individuals (exercises < 2 days/week)
  • fasting blood glucose between 100-125 mg/dl (pre-diabetes)
  • BMI of 25-40.

Exclusion Criteria:

  • physically active lifestyle (exercise > two days/week)
  • pregnancy
  • history of cigarette smoking
  • medication and/or dietary supplement to control blood glucose, lipids, or blood pressure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control Phase
cellulose (600 mg)
Dietary supplement: Cellulose
600mg/day oral dose of placebo cellulose
Experimental: Experimental Phase
alpha lipoic acid (600 mg)
Dietary supplement: alpha lipoic acid
600 mg/day oral dose of alpha lipoic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic control
Time Frame: 1 month
blood glucose and insulin
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood lipids
Time Frame: 1 month
Blood cholesterol
1 month
Blood lipids
Time Frame: 1 month
Triglycerides
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York at Buffalo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

December 30, 2018

Study Completion (Actual)

December 30, 2018

Study Registration Dates

First Submitted

July 16, 2018

First Submitted That Met QC Criteria

July 26, 2018

First Posted (Actual)

August 2, 2018

Study Record Updates

Last Update Posted (Actual)

December 1, 2020

Last Update Submitted That Met QC Criteria

November 27, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MODCR00002022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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