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NCT04583722

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

Completed NA Last updated 1 April 2021
What this trial tests

NA trial testing AX-olive oil-PP emulsion in Bioavailability in 13 participants. Completed in 16 January 2019.

Timeline
15 July 2018
Primary endpoint
30 November 2018
16 January 2019

Quick facts

Lead sponsorYoav D. Livney
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingtriple
Primary purposebasic science
Enrollment13
Start date15 July 2018
Primary completion30 November 2018
Estimated completion16 January 2019
Sites1 location across Israel

Drugs / interventions tested

Conditions studied

Sponsor

Yoav D. Livney

Who can join

Adults 18 to 26, any sex, with Bioavailability. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Data sources for this page

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