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

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ClinicalTrials.gov Identifier: NCT03310359
Recruitment Status : Recruiting
First Posted : October 16, 2017
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Robert R. Henry, MD, University of California, San Diego

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
Metabolic Syndrome X Dietary Supplement: Astaxanthin Other: Placebo Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated 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 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 : July 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants
Drug Information available for: Astaxanthin

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 Name: 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




Primary Outcome Measures :
  1. Change in insulin sensitivity [ Time Frame: 6 months ]
    Change from baseline insulin sensitivity during hyperinsulinemic/euglycemic clamp at 6 months.


Secondary Outcome Measures :
  1. Change in lipid control [ Time Frame: 6 months ]
    Change from baseline suppression of Free Fatty Acids (FFAs) during hyperinsulinemic/euglycemic clamp at 6 months.

  2. Change in fasting glucose [ Time Frame: 6 months ]
    Change from baseline fasting glucose at 6 months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03310359


Contacts
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Contact: Jeremy Pettus, MD 858-246-2151 jpettus@ucsd.edu
Contact: Theodore Ciaraldi, PhD 858-552-8585 ext 6450 tciaraldi@ucsd.edu

Locations
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United States, California
Altman Clinical and Translational Research Institute (ACTRI) Recruiting
San Diego, California, United States, 92037
Contact: Adrienne Armstrong, BA    858-246-2151    a3armstrong@ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Jeremy Pettus, MD UCSD

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Responsible Party: Robert R. Henry, MD, Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03310359    
Other Study ID Numbers: 151542
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Antioxidants
Hypoglycemic Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents