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

NCT03310359 | Completed

• 1 other identifier: 151542
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome X

Outcome Measures

Primary Outcomes (1)

• Change in insulin sensitivity

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

  6 months

Secondary Outcomes (2)

• Change in lipid control

  6 months

• Change in fasting glucose

  6 months

Study Arms (2)

Astaxanthin (12 mg)

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Astaxanthin DIETARY_SUPPLEMENT

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.

Also known as: Haematococcus pluvialis

Astaxanthin (12 mg)

Placebo OTHER

Matching placebo pill

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Other disease, besides type 2 diabetes, influencing carbohydrate metabolism.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

Altman Clinical and Translational Research Institute (ACTRI)

San Diego, California, 92037, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

astaxanthine

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jeremy Pettus, MD

  UCSD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: A double-blinded, placebo controlled, Clinical Trial of Insulin-Sensitizing, Anti-Inflammatory and Anti-oxidant activities of Astaxanthin in Insulin-resistant Subjects

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: October 16, 2017
• Study Start: July 1, 2016
• Primary Completion: March 31, 2021
• Study Completion: December 31, 2022
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)