Clinical trial NCT04583722: Evaluating Astaxanthin Bioavailability, and a New Technology for Improving it, Using Natural Food Materials Only
Official title: Clinical Evaluation of a New Encapsulation Technology for Improving Astaxanthin Bioavailability Based on Natural Food Ingredients Only
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bioavailability
Keywords: Astaxanthin
Bioavailability
Encapsulation
Potato protein
Olive oil
Lead sponsor: Technion, Israel Institute of Technology
Sponsor class: OTHER
Collaborators: name: Israel Innovation Authority
First posted: 2020-10-12
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasma AX AUC
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Campus
Study officials:
affiliation: Endocrine Institute, Rambam Health Care Campus
name: Elena Segal, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abuhassira-Cohen Y, Edelman R, Abbas R, Kurnik D, Shibel R, Livney YD, Enhancing the oral bioavailability of natural astaxanthin using plant-based micro- and nano-encapsulation materials: Results of an In vitro evaluation and a cross-over study in humans, Precision Nanomedicine 2020; 3 (4), 641-655.