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

January 19, 2024 updated by: Jeremy Pettus, MD, University of California, San Diego

A Double-blinded, Placebo-controlled, Clinical Trial of Insulin-sensitizing, Anti-inflammatory and Anti-oxidant Activities of Astaxanthin in Insulin-resistant Subjects

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92037
        • Altman Clinical and Translational Research Institute (ACTRI)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in insulin sensitivity
Time Frame: 6 months
Change from baseline insulin sensitivity during hyperinsulinemic/euglycemic clamp at 6 months.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in lipid control
Time Frame: 6 months
Change from baseline suppression of Free Fatty Acids (FFAs) during hyperinsulinemic/euglycemic clamp at 6 months.
6 months
Change in fasting glucose
Time Frame: 6 months
Change from baseline fasting glucose at 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Diego

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jeremy Pettus, MD, UCSD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 151542

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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