Impact of Alpha-Lipoic Acid Ingestion on Glucose Tolerance in Subjects With Pre-Diabetes
Condition: PreDiabetes
MeSH terms: Prediabetic State; Glucose Intolerance
Study type: Interventional

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.
    


Intervention name(s): alpha lipoic acid; Cellulose
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 600 mg/day oral dose of alpha lipoic acid; 600mg/day oral dose of placebo cellulose
Intervention MeSH terms: Thioctic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pre-diabetes; glucose; insulin; blood lipids; alpha lipoic acid