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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04583722
Other study ID # 0048-18-RMB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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