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

NCT03612037 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-12-01

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

alpha lipoic acid

600 mg/day oral dose of alpha lipoic acid

DIETARY_SUPPLEMENT

Cellulose

600mg/day oral dose of placebo cellulose

Sponsors & Collaborators

  • State University of New York at Buffalo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-01
Primary Completion
2018-12-30
Completion
2018-12-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03612037 on ClinicalTrials.gov