Bioavailability of Astaxanthin Formulations

Study Overview
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Brief Summary
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Bioavailability of dietary supplement formulations in healthy volunteers after a single oral dose.

Detailed Description
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Comparison of the bioavailability of 3 formulations with astaxanthin in healthy volunteers after single dose

Official Title
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Bioavailability of Astaxanthin Formulations

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Dietary Supplement: Astaxanthin


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 50 years of age, inclusive, at the baseline visit. Exclusion Criteria: 1. Are unwilling to follow the procedures of the trial, such as making visits or having their blood drawn. 2. Have unintentionally lost or gained 10 or more kg of body weight in the last 3 months; 3. Have an acute illness (such as a severe cold or flu) or have been hospitalized within the past month for certain conditions; 4. Have severe co-morbid disease including cardiac, pulmonary, renal, hepatic, carotid, peripheral vascular disease, stroke, neurological, clotting disorders or active cancer; 5. Taking chronic drugs which interfere with lipids metabolism (statins or similar) 6. 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 or one glass of wine equals one portion of hard liquor). 7. Consume carotenoids as food supplements. 8. Have a Body Mass Index (BMI) of less than 17 or greater than 35 m/kg2; 9. Have participated in a clinical trial in the past 4 weeks; 10. Have any disease or condition that in the investigator's opinion compromises the integrity of the clinical trial or the safety of the subject; 11. Smokers 12. Pregnant woman

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 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

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Astaxanthin formulation #1<br>capsules | Dietary Supplement: Astaxanthin<br>* an oral dose form<br>|
| Active Comparator: Astaxanthin formulation #2<br>tablets | Dietary Supplement: Astaxanthin<br>* an oral dose form<br>|
| Active Comparator: Astaxanthin formulation #3<br>powder | Dietary Supplement: Astaxanthin<br>* an oral dose form<br>|
| Experimental: Astaxanthin formulations<br>fast condition | Dietary Supplement: Astaxanthin<br>* an oral dose form<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma level | astaxanthin in plasma | 0-48 hr |