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

University at Buffalo (UB) logo

University at Buffalo (UB)

Status

Completed

Conditions

PreDiabetes

Treatments

Dietary Supplement: alpha lipoic acid
Dietary Supplement: Cellulose

Study type

Interventional

Funder types

Other

Identifiers

NCT03612037
MODCR00002022

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

12 participants in 2 patient groups, including a placebo group

Control Phase
Placebo Comparator group
Description:
cellulose (600 mg)
Treatment:
Dietary Supplement: Cellulose
Experimental Phase
Experimental group
Description:
alpha lipoic acid (600 mg)
Treatment:
Dietary Supplement: alpha lipoic acid

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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