University of California started a new double-blinded, Placebo-controlled, Clinical Trial of Insulin-sensitizing, Anti-inflammatory and Anti-oxidant Activities of Astaxanthin in Insulin-resistant Subjects.

The company University of California, San Diego is enrolling patients into the clinical trial investigating Clinical Trial of Anti-oxidant Astaxanthin in Insulin-resistant Subjects (Astaxanthin).

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.

The trial is designed to enroll male and female 18 Years to 75 Years and is being conducted in the Altman Clinical and Translational Research Institute (ACTRI), San Diego, California, United States.

The study start date is July 2016.

The patients that can be enrolled into this study include:

  • Age: 18-75 years (inclusive) - Both males and females - If female, must be post-menopausal or not capable of becoming pregnant - Able to give informed consent to the procedures - Dyslipidemia - [TG]>150, or [LDL]>100 or [HDL]<40 for males, <50 for females or taking a statin or fibrate - BMI = 25-39 - Impaired fasting glucose 95>[FG]<125 and/or elevated HbA1c (5.7-6.4%) - Concomitant medication use stable for 30 days prior to screening visit (Acceptable medications: anti-hypertensive if blood pressure criteria met statins or fibrates) Exclusion Criteria: - Type 2 diabetes - Type 1 diabetes - Pregnant - Younger than 18 or older than 75 years of age. - Clinically significant abnormalities in liver (> 3x ULN) or kidney function (eGFR < 30) - Myocardial Infarction (MI) (within 6 months of screening) - Stroke (within 6 months of screening) - Blood pressure (BP) >160 mmHg Systolic and >100 mmHg Diastolic - The following medications are exclusionary: thiazolidinediones, any steroids, anti-depressants, weight loss, and OTC antioxidants (if taking OTC antioxidant supplements, subjects must be willing to stop taking them immediately upon site verifying that the subject qualifies for enrollment and for the duration of the entire study. Some OTC antioxidants may be acceptable upon approval by the Principal Investigator.) - Other disease, besides type 2 diabetes, influencing carbohydrate metabolism.

The population that are excluded from participation:

  • Type 2 diabetes - Type 1 diabetes - Pregnant - Younger than 18 or older than 75 years of age. - Clinically significant abnormalities in liver (> 3x ULN) or kidney function (eGFR < 30) - Myocardial Infarction (MI) (within 6 months of screening) - Stroke (within 6 months of screening) - Blood pressure (BP) >160 mmHg Systolic and >100 mmHg Diastolic - The following medications are exclusionary: thiazolidinediones, any steroids, anti-depressants, weight loss, and OTC antioxidants (if taking OTC antioxidant supplements, subjects must be willing to stop taking them immediately upon site verifying that the subject qualifies for enrollment and for the duration of the entire study. Some OTC antioxidants may be acceptable upon approval by the Principal Investigator.) - Other disease, besides type 2 diabetes, influencing carbohydrate metabolism.

This page provides a more detailed overview of this clinical trial:https://ichgcp.net/clinical-trials-registry/NCT03310359

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