Clinical Trial of Anti-oxidant Astaxanthin in Insulin-resistant Subjects
Condition: Metabolic Syndrome X
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      Astaxanthin is a natural compound, present in many foodstuffs and available as a nutritional
      supplement that has been shown to have beneficial effects on many of the features of insulin
      resistance/glucose intolerance, at least in animals. The goal of this project is to provide a
      validation of astaxanthin effects on metabolic regulation in humans and their mechanism(s) of
      action, to determine if astaxanthin could have any value as a "neutraceutical" to help
      improve regulation of glucose and fat metabolism in subjects with insulin resistance/ glucose
      intolerance.
    

Detailed description: 
      Astaxanthin is a molecule of the carotenoid class that is abundant in marine animals and
      plants, with the algae Haematococcus pluvialis being a particularly rich source. Astaxanthin
      is a potent anti-oxidant with a unique property of being able to insert into membranes and
      lipid bilayers. Astaxanthin has also been shown to be a potent anti-inflammatory agent. As
      oxidative stress and inflammation are present in individuals with insulin resistance,
      astaxanthin offers promise as a potential therapeutic for this patient population.

      There are a number of formulations of astaxanthin that are available for use in humans. With
      regard to controlled studies in humans, astaxanthin has been given at doses as high as 40
      mg/day for periods from 2 to 12 weeks. Improvements in inflammation and oxidative stress were
      frequently observed. With regard to metabolic regulation, improvements have been seen in HDL
      and LDL levels, while others have found no changes. Glucose and insulin levels appear to be
      unaltered: This lack of effect may be due to only healthy, though in some cases overweight or
      obese, subjects being studied. In none of these studies, were any abnormal safety lab values
      or adverse events reported. One of the intents of the current project is to perform more
      detailed metabolic characterization of astaxanthin treatment effects in research participants
      with insulin resistance/glucose intolerance.

      The hyperinsulinemic-euglycemic glucose clamp procedure (HEC) will be used to assess insulin
      sensitivity and responsiveness by measuring glucose disposal rate (GDR). Investigators will
      also perform Oral Glucose Tolerance Tests (OGTT), indirect calorimetry (IDC), and 24 hour
      measurement of ambulatory blood pressure (ABPM).
    

Intervention name(s): Astaxanthin; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): The agent to be tested is astaxanthin, isolated from H. pluvialis following GMP standards. A GRAS notice (GRN000294) was accepted by the Food and Drug Administration (FDA) in January 2010. Agent is stored in capsules at room temperature.; Matching placebo pill
Other intervention name(s): Haematococcus pluvialis
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A double-blinded, placebo controlled, Clinical Trial of Insulin-Sensitizing, Anti-Inflammatory and Anti-oxidant activities of Astaxanthin in Insulin-resistant Subjects
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other