- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03310359
Clinical Trial of Anti-oxidant Astaxanthin in Insulin-resistant Subjects (Astaxanthin)
A Double-blinded, Placebo-controlled, Clinical Trial of Insulin-sensitizing, Anti-inflammatory and Anti-oxidant Activities of Astaxanthin in Insulin-resistant Subjects
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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San Diego, California, United States, 92037
- Altman Clinical and Translational Research Institute (ACTRI)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Astaxanthin (12 mg)
Subjects will be given capsules containing a set oral dose of astaxanthin (12 mg) and instructed to take two capsules each morning after (up to 1 hr) the morning meal for a total of up to 24 weeks (168 days on study drug).
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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.
Other Names:
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Placebo Comparator: Placebo
Subjects will be given capsules containing placebo and instructed to take two capsules each morning after (up to 1 hr) the morning meal for a total of up to 24 weeks (168 days on study drug).
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Matching placebo pill
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in insulin sensitivity
Time Frame: 6 months
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Change from baseline insulin sensitivity during hyperinsulinemic/euglycemic clamp at 6 months.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in lipid control
Time Frame: 6 months
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Change from baseline suppression of Free Fatty Acids (FFAs) during hyperinsulinemic/euglycemic clamp at 6 months.
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6 months
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Change in fasting glucose
Time Frame: 6 months
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Change from baseline fasting glucose at 6 months
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6 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Jeremy Pettus, MD, UCSD
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 151542
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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