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 Details — Status: Completed

Administrative data

• NCT number: NCT04583722
• Other study ID #: 0048-18-RMB
• Status: Completed
• Phase: N/A
• Start date: July 15, 2018
• Est. completion date: January 16, 2019

Study information

• Verified date: March 2021
• Source: Technion, Israel Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 16, 2019
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 26 Years

Eligibility

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

Related Conditions & MeSH terms

• Bioavailability

Intervention

Dietary Supplement:
• AX-olive oil-PP emulsion
single dose and plasma samples

Locations

Country	Name	City	State
Israel	Rambam Health Campus	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
Yoav D. Livney	Israel Innovation Authority

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   The publication reporting the clinical study