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

NCT ID: NCT03612037

Last Updated: 2020-12-01

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2018-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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PreDiabetes

Keywords

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pre-diabetes glucose insulin blood lipids alpha lipoic acid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control Phase

cellulose (600 mg)

Group Type PLACEBO_COMPARATOR

Cellulose

Intervention Type DIETARY_SUPPLEMENT

600mg/day oral dose of placebo cellulose

Experimental Phase

alpha lipoic acid (600 mg)

Group Type EXPERIMENTAL

alpha lipoic acid

Intervention Type DIETARY_SUPPLEMENT

600 mg/day oral dose of alpha lipoic acid

Interventions

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alpha lipoic acid

600 mg/day oral dose of alpha lipoic acid

Intervention Type DIETARY_SUPPLEMENT

Cellulose

600mg/day oral dose of placebo cellulose

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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State University of New York at Buffalo

OTHER

Sponsor Role lead

Responsible Party

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Todd Rideout

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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MODCR00002022

Identifier Type: -

Identifier Source: org_study_id