Clinical Trial of Anti-oxidant Astaxanthin in Insulin-resistant Subjects (Astaxanthin)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03310359|
Recruitment Status : Recruiting
First Posted : October 16, 2017
Last Update Posted : May 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome X||Dietary Supplement: Astaxanthin Other: Placebo||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|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)|
|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|
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).
Matching placebo pill
- Change in insulin sensitivity [ Time Frame: 6 months ]Change from baseline insulin sensitivity during hyperinsulinemic/euglycemic clamp at 6 months.
- Change in lipid control [ Time Frame: 6 months ]Change from baseline suppression of Free Fatty Acids (FFAs) during hyperinsulinemic/euglycemic clamp at 6 months.
- Change in fasting glucose [ Time Frame: 6 months ]Change from baseline fasting glucose at 6 months
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
|Contact: Jeremy Pettus, MDemail@example.com|
|Contact: Theodore Ciaraldi, PhD||858-552-8585 ext firstname.lastname@example.org|
|United States, California|
|Altman Clinical and Translational Research Institute (ACTRI)||Recruiting|
|San Diego, California, United States, 92037|
|Contact: Adrienne Armstrong, BA 858-246-2151 email@example.com|
|Principal Investigator:||Jeremy Pettus, MD||UCSD|