Evaluating Astaxanthin Bioavailability, and a New Technology for Improving it, Using Natural Food Materials Only

Study Overview
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Brief Summary
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The purpose of this study was to develop a potato protein (PP)-based delivery system for increasing oral bioavailability of lipophilic bioactives (nutraceuticals and drugs), using astxanthin (AX) as a model, and to evaluate the system in vivo in a crossover clinical study in human volunteers. Three different formulations were prepared, encapsulating AX oleoresin (AXO) with (1) PP only, (2) PP+lecithin (LEC), and (3) PP+olive oil (OO). In a randomized, double-blind, crossover study in human subjects, the PP-OO-AX formulation had a 4.8-fold higher median plasma AX area under the concentration-over time curve (AUC; P<0.001) compared to the raw AXO formulation. In conclusion, a non-allergenic, vegan, PP based delivery system made of all-natural ingredients offers a great promise for increasing oral bioavailability of lipophilic bioactives such as AX, for the enrichment of food and for dietary supplements, or oral delivery of lipophilic drugs.

Detailed Description
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Astaxanthin (AX) is a red xanthophyll carotenoid found mainly in algae (notably Haematococcus Pluvialis microalga) and marine animals. AX is a stronger antioxidant than vitamin E and β-carotene but has very low oral bioavailability. The purpose of this study was to develop a potato protein (PP)-based delivery system for increasing oral bioavailability of lipophilic bioactives (nutraceuticals and drugs), using AX as a model, and to evaluate the system in vitro and in vivo in a crossover clinical study in human volunteers. Three different formulations were prepared, encapsulating AX oleoresin (AXO) with (1) PP only, (2) PP+lecithin (LEC), and (3) PP+olive oil (OO). The average particle diameters after preparation were 0.29, 0.29, and 1.76 μm, and after freeze-drying and reconstitution 0.17, 0.07, and 6.93 μm, respectively. In vitro bioaccessibility was 33, 47, and 69%, respectively, versus 16% only for the raw AXO. In a randomized, double-blind, crossover study in human subjects, the PP-OO-AX formulation had a 4.8-fold higher median plasma AX area under the concentration-over time curve (AUC; P<0.001) compared to the raw AXO formulation. In conclusion, a non-allergenic, vegan, PP based delivery system made of all-natural ingredients offers a great promise for increasing oral bioavailability of lipophilic bioactives such as AX, for the enrichment of food and for dietary supplements, or oral delivery of lipophilic drugs.

Official Title
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Clinical Evaluation of a New Encapsulation Technology for Improving Astaxanthin Bioavailability Based on Natural Food Ingredients Only

Conditions
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Bioavailability

Intervention / Treatment
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* Dietary Supplement: AX-olive oil-PP emulsion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers Aged 18 - 26 Normal physical examination Normal electrocardiogram (E.C.G.) Normal laboratory profile Exclusion Criteria: Any active medical illness (e.g. liver disease, kidney disease, or diabetes, intestinal malabsorption, hypercalcemia) Lactose intolerance Food allergies Excessive alcohol use (over 40 ml/day) Pregnant or breast-feeding Hyperlipidemia (LDL>130, triglycerides>200) Regular medication use Obesity (BMI>30 kg/m2) Use of multivitamins, or carotenoid supplements during the past month prior to the study Current smoking

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 26 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: AX oleoresin<br>Raw AX oleoresin, 15 mg AX (in 4 pululan capsules) | Dietary Supplement: AX-olive oil-PP emulsion<br>* single dose and plasma samples<br>* Other names: (control- raw AXoleoresin);|
| Experimental: AX-olive oil-PP emulsion<br>Microencapsulated AX (1%:2%:3% (AXO:OO:PP, %w/v ratio) + 0.15% maltodextrin). 15 mg AX (in 4 pululan capsules) | Dietary Supplement: AX-olive oil-PP emulsion<br>* single dose and plasma samples<br>* Other names: (control- raw AXoleoresin);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma AX AUC | Plasma AX AUC of 13 participants after consuming either the microencapsulated AX or the reference AX oleoresin, measured during 72 hrs post-ingestion, in a cross over study. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Astaxanthin, Bioavailability, Encapsulation, Potato protein, Olive oil