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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03612037
Enrollment
12
Registered
2018-08-02
Start date
2016-09-01
Completion date
2018-12-30
Last updated
2020-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PreDiabetes

Keywords

pre-diabetes, glucose, insulin, blood lipids, alpha lipoic acid

Brief 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.

Interventions

DIETARY_SUPPLEMENTalpha lipoic acid

600 mg/day oral dose of alpha lipoic acid

DIETARY_SUPPLEMENTCellulose

600mg/day oral dose of placebo cellulose

Sponsors

State University of New York at Buffalo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Glycemic control1 monthblood glucose and insulin

Secondary

MeasureTime frameDescription
Blood lipids1 monthBlood cholesterol

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026