Astaxanthin Formulation Bioavailability

Study Overview
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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.

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.

Official Title
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Bioavailability Testing of Astaxanthin Formulations

Conditions
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Bioavailability of Astaxanthin Formulations

Intervention / Treatment
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* Dietary Supplement: Enteric Coated Softgels
* Dietary Supplement: Liposomal astaxanthin
* Dietary Supplement: Standard Softgel
* Dietary Supplement: Astaxanthin Water Soluble Emulsion
* Dietary Supplement: Astaxanthin Water Dispersible Powder
* Dietary Supplement: Standard Softgel with Astaxanthin Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:Subjects who have signed an informed consent form and who meet all of the following entrance criteria may be enrolled in this clinical trial: Generally healthy men and women who are 21 to 65 years of age, inclusive, at the baseline visit. - Exclusion Criteria:Subjects who meet any of the following exclusion criteria are not eligible for participation in this clinical trial: Are unwilling to follow the procedures of the trial, such as making visits or having their blood drawn. Have unintentionally lost or gained 10 or more pounds of body weight in the last 3 months; Have an acute illness (such as a severe cold or flu) or have been hospitalized within the past month for certain conditions; Have severe co-morbid disease including cardiac, pulmonary, renal, hepatic, carotid, peripheral vascular disease, stroke, neurological, clotting disorders or active cancer; Consume alcohol at an elevated level (Defined as consumption of more than 10 standard alcoholic drinks per week. A standard alcoholic drink is defined as one bottle/can of beer (12 ounces) equals one glass of wine (4 ounces) equals one ounce of hard liquor). Have a Body Mass Index (BMI) of less than 15 or greater than 55 m/kg2; Have participated in a clinical trial in the past 4 weeks; Have any disease or condition that in the investigator's opinion compromises the integrity of the clinical trial or the safety of the subject; Severe co-morbid disease is defined as any condition that would cause severe limitations or inability to carry out usual activities of daily living. The exclusion criteria identified above are based upon general safety concerns identified by the study supervisor with input from medical director, or confounders identified by the biostatistician. -

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enteric Coated Softgels<br>Enteric coated softgel capsule containing 4 mg astaxanthin, 3 softgels per dose | Dietary Supplement: Enteric Coated Softgels<br>* Enteric coated softgel capsule containing 4 mg astaxanthin, 3 softgels per dose<br>* Other names: BioAstin;|
| Experimental: Liposomal Astaxanthin<br>Liposomal astaxanthin containing 4.5 mg astaxanthin per gram. 2.66 grams per dose | Dietary Supplement: Liposomal astaxanthin<br>* Liposomal astaxanthin containing 4.5 mg astaxanthin per gram. 3.66 grams per dose<br>* Other names: BioAstin;|
| Experimental: Standard Softgel<br>Standard softgel containing 4 mg per softgel. 3 softgels per dose | Dietary Supplement: Standard Softgel<br>* Standard softgel containing 4 mg astaxanthin per softgel. 3 softgels per dose<br>* Other names: BoAstin;|
| Experimental: Astaxanthin Water Soluble Emulsion<br>Astaxanthin water soluble emulsion containing 1% astaxanthin. 1.2 grams per dose | Dietary Supplement: Astaxanthin Water Soluble Emulsion<br>* Astaxanthin water soluble emulsion containing 1% astaxanthin. 1.2 grams per dose<br>* Other names: BioAstin;|
| Experimental: Astaxanthin Water Dispersible Powder<br>Astaxanthin water dispersible powder containing 3% astaxanthin. 0.4 grams per dose | Dietary Supplement: Astaxanthin Water Dispersible Powder<br>* Astaxanthin water dispersible powder containing 3% astaxanthin. 0.4 grams per dose<br>* Other names: BioAstin;|
| Experimental: Standard Softgel with Astaxanthin Gel<br>Statndard softgel with astaxanthin gel containing 4 mg astaxanthin. 3 softgels per dose | Dietary Supplement: Standard Softgel with Astaxanthin Gel<br>* Standard softgel with astaxanthin gel containing 4 mg astaxanthin. 3 soft gels per dose<br>* Other names: BioAstin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration Cmax) of astaxanthin |  | 24 hurs | 
| Area under the plasma concentration versus time curve (AUC) of astaxanthin |  | 24 hours |