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

Sponsor

State University of New York at Buffalo (Other)

Overall Status

Completed

CT.gov ID

NCT03612037

Collaborator

(none)

Enrollment

Arms

27.9

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
PreDiabetes	Dietary Supplement: alpha lipoic acid Dietary Supplement: Cellulose	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2016

Actual Primary Completion Date :

Dec 30, 2018

Actual Study Completion Date :

Dec 30, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Glycemic control [1 month]
blood glucose and insulin

Secondary Outcome Measures

Blood lipids [1 month]
Blood cholesterol
Blood lipids [1 month]
Triglycerides

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.