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

Bioavailability Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04583722
Study type Interventional
Source Technion, Israel Institute of Technology
Contact
Status Completed
Phase N/A
Start date July 15, 2018
Completion date January 16, 2019
View Details
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