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Clinical Trial of Anti-oxidant Astaxanthin in Insulin-resistant Subjects

Sponsor
University of California, San Diego (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03310359
Collaborator
(none)
34
Enrollment
1
Location
2
Arms
66
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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/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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Astaxanthin
  • Other: Placebo
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
34 participants
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 SubjectsA 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
Official Title:
A Double-blinded, Placebo-controlled, Clinical Trial of Insulin-sensitizing, Anti-inflammatory and Anti-oxidant Activities of Astaxanthin in Insulin-resistant Subjects
Study Start Date :
Jul 1, 2016
Actual Primary Completion Date :
Mar 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

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).

Dietary Supplement: Astaxanthin
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:
  • Haematococcus pluvialis

    		•
    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).

    Other: Placebo
    Matching placebo pill

    Outcome Measures

    Primary Outcome Measures

    1. Change in insulin sensitivity [6 months]

      Change from baseline insulin sensitivity during hyperinsulinemic/euglycemic clamp at 6 months.

    Secondary Outcome Measures

    1. Change in lipid control [6 months]

      Change from baseline suppression of Free Fatty Acids (FFAs) during hyperinsulinemic/euglycemic clamp at 6 months.

    2. Change in fasting glucose [6 months]

      Change from baseline fasting glucose at 6 months

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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 <

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Altman Clinical and Translational Research Institute (ACTRI) San Diego California United States 92037

    Sponsors and Collaborators

    • University of California, San Diego

    Investigators

    • Principal Investigator: Jeremy Pettus, MD, UCSD

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jeremy Pettus, MD, Assistant Professor of Medicine, University of California, San Diego
    ClinicalTrials.gov Identifier:
    NCT03310359
    Other Study ID Numbers:
    • 151542
    First Posted:
    Oct 16, 2017
    Last Update Posted:
    Sep 29, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Metabolic Syndrome

    Study Results

    No Results Posted as of Sep 29, 2021