Astaxanthin Formulation Bioavailability

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-12-31

Brief Summary

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Human crossover pharmacokinetic study involving 12 subjects to determine the relative bioavailability of astaxanthin in six commercially available oral formulations.

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Detailed Description

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Astaxanthin is commercially available through several vendors. As a highly-lipophilic compound, its oral bioavailability is likely limited by its solubility in the gut. Pre-formulation strategies for addressing limited solubility include pre-dissolving the astaxanthin in fatty solvents and encapsulating in gelatin capsules. This study will evaluate the oral bioavailability of six different formulations of astaxanthin (12mg) in a double blind crossover study involving 12 subjects.

All subjects will be asked to abstain from consuming any salmon 48hrs before and consuming any food or alcoholic beverages 10 hours before reporting to the blood draw center at 8 AM. They will be fed a standardized breakfast by choosing one of two Jimmy Dean brand breakfast sandwiches (EGG, RED PEPPERS, ONIONS AND PEPPER JACK CHEESE CROISSANT or BACON, EGG \& CHEESE BISCUIT. Immediately following the standardized meal, they will take one of six different formulations each containing 12 mg of astaxanthin. Bottled water (Zephyrhills® Brand 100% Natural Spring Water) will be available to each subject ad lib. Blood will be collected immediately before consuming the standardized meal and formulation (0 hr) and then again at 4, 8, 10, and 24 hours post dose by a licensed phlebotomist. In between blood draws, the subjects will be allowed to leave the clinic and allowed to resume their normal diet and lifestyle. However, they will be asked to abstain from consuming any alcoholic beverages or salmon until after completion of the last blood draw at 24hrs. As a measure of quality control, each subject will receive a breathalyzer test for alcohol prior to the 0 and 24 hr blood draws. For each time point, blood will be collected in one 10ml Vacutainer Tube (BD 16x100 containing K2 EDTA) labeled using the randomization scheme to blind the samples. Because 3 of the formulations are powders and the remaining 3 formulations are capsules, which differ slightly size and appearance, neither the subjects nor investigators will be blind to the formulation being tested on any given day. However, each subject will receive separate random assignment to each of the 6 formulations tested over the course of the study and all blood samples will be blinded to the quantitative analysis of astaxanthin plasma levels. This process will be repeated six times for the entire subject population (with-in subject design) with two-week washout periods between each pharmacokinetic (pK) run. The blinded blood samples will be kept refrigerated and will be transported to the Center for Excellence and Brain Repair (CEABR) lab within 24 hours, where it will be processed and subjected to the High pressure liquid chromatograph (HPLC) analysis to quantify the astaxanthin.

Conditions

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Bioavailability of Astaxanthin Formulations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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