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

Sponsor

Yoav D. Livney (Other)

Overall Status

Completed

CT.gov ID

NCT04583722

Collaborator

Israel Innovation Authority (Other)

Enrollment

Location

Arms

6.1

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bioavailability	Dietary Supplement: AX-olive oil-PP emulsion	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jul 15, 2018

Actual Primary Completion Date :

Nov 30, 2018

Actual Study Completion Date :

Jan 16, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: AX oleoresin Raw AX oleoresin, 15 mg AX (in 4 pululan capsules)	Dietary Supplement: AX-olive oil-PP emulsion single dose and plasma samples Other Names: (control- raw AXoleoresin)
Experimental: AX-olive oil-PP emulsion 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 single dose and plasma samples Other Names: (control- raw AXoleoresin)

Arm

Intervention/Treatment

Other: AX oleoresin

Raw AX oleoresin, 15 mg AX (in 4 pululan capsules)

Dietary Supplement: AX-olive oil-PP emulsion

single dose and plasma samples

Other Names:

(control- raw AXoleoresin)

Experimental: AX-olive oil-PP emulsion

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

single dose and plasma samples

Other Names:

(control- raw AXoleoresin)

Outcome Measures

Primary Outcome Measures

Plasma AX AUC [1 year]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 26 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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