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

NCT ID: NCT04583722

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-15
• Study Completion Date: 2019-01-16

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.

Conditions

Bioavailability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

AX oleoresin

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

Group Type: OTHER

AX-olive oil-PP emulsion

Intervention Type: DIETARY_SUPPLEMENT

single dose and plasma samples

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)

Group Type: EXPERIMENTAL

AX-olive oil-PP emulsion

Intervention Type: DIETARY_SUPPLEMENT

single dose and plasma samples

Interventions

AX-olive oil-PP emulsion

single dose and plasma samples

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

(control- raw AXoleoresin)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Israel Innovation Authority

UNKNOWN

Sponsor Role: collaborator

Yoav D. Livney

OTHER

Sponsor Role: lead

Responsible Party

Yoav D. Livney

Prof.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Elena Segal, Doctor

Role: PRINCIPAL_INVESTIGATOR

Endocrine Institute, Rambam Health Care Campus

Locations

Rambam Health Campus

Haifa, , Israel

Countries

Israel

References

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.

Reference Type: BACKGROUND

Related Links

https://doi.org/10.33218/001c.16781

The publication reporting the clinical study

Other Identifiers

0048-18-RMB

Identifier Type: -

Identifier Source: org_study_id