Astaxanthin Formulation Bioavailability
Condition: Bioavailability of Astaxanthin Formulations
Study type: Interventional

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

Detailed description: 
      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.
    

Intervention name(s): Enteric Coated Softgels; Liposomal astaxanthin; Standard Softgel; Astaxanthin Water Soluble Emulsion; Astaxanthin Water Dispersible Powder; Standard Softgel with Astaxanthin Gel
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Enteric coated softgel capsule containing 4 mg astaxanthin, 3 softgels per dose; Liposomal astaxanthin containing 4.5 mg astaxanthin per gram. 3.66 grams per dose; Standard softgel containing 4 mg astaxanthin per softgel. 3 softgels per dose; Astaxanthin water soluble emulsion containing 1% astaxanthin. 1.2 grams per dose; Astaxanthin water dispersible powder containing 3% astaxanthin. 0.4 grams per dose; Standard softgel with astaxanthin gel containing 4 mg astaxanthin. 3 soft gels per dose
Other intervention name(s): BioAstin; BioAstin; BoAstin; BioAstin; BioAstin; BioAstin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)