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

NCT03310359 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2024-01-23

No results posted yet for this study

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

Interventions

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

Placebo

Matching placebo pill

Sponsors & Collaborators

Principal Investigators

  • Jeremy Pettus, MD · UCSD

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2021-03-31
Completion
2022-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03310359 on ClinicalTrials.gov