Status:
COMPLETED
Clinical Trial of Anti-oxidant Astaxanthin in Insulin-resistant Subjects
Lead Sponsor:
University of California, San Diego
Conditions:
Metabolic Syndrome X
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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/glu...
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-o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03310359
Start Date
July 1 2016
End Date
December 31 2022
Last Update
January 23 2024
Active Locations (1)
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1
Altman Clinical and Translational Research Institute (ACTRI)
San Diego, California, United States, 92037