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

Yoav D. Livney

Status

Completed

Conditions

Bioavailability

Treatments

Dietary Supplement: AX-olive oil-PP emulsion

Study type

Interventional

Funder types

Other

Identifiers

NCT04583722

0048-18-RMB

Details and patient eligibility

About

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.

Full 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.

Enrollment

13 patients

Sex

All

Ages

18 to 26 years old

Volunteers

Accepts Healthy Volunteers

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