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

Not Applicable

Completed

• Conditions: Bioavailability
• Interventions: Dietary Supplement: AX-olive oil-PP emulsion

• Registration Number: NCT04583722
• Lead Sponsor: Yoav D. Livney

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.

Study Timeline

• Study Start: 2018-07-15
• Primary Completion: 2018-11-30
• Study Completion: 2019-01-16
• Study First Submitted: 2020-10-05
• Study First Submitted QC: 2020-10-09
• Study First Posted: 2020-10-12
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-30
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AX oleoresin	AX-olive oil-PP emulsion	Raw AX oleoresin, 15 mg AX (in 4 pululan capsules)
AX-olive oil-PP emulsion	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)

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Rambam Health Campus; 🇮🇱 Haifa, Israel