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NCT04583722
Evaluating Astaxanthin Bioavailability, and a New Technology for Improving it, Using Natural Food Materials Only
NA trial testing AX-olive oil-PP emulsion in Bioavailability in 13 participants. Completed in 16 January 2019.
30 November 2018
Quick facts
| Lead sponsor | Yoav D. Livney |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | basic science |
| Enrollment | 13 |
| Start date | 15 July 2018 |
| Primary completion | 30 November 2018 |
| Estimated completion | 16 January 2019 |
| Sites | 1 location across Israel |
Drugs / interventions tested
- AX-olive oil-PP emulsion
Conditions studied
- Bioavailability — all drugs for Bioavailability →
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.
Verify or expand the search:
- PubMed search for NCT04583722
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Bioavailability
Currently open trials in the same condition.
- NCT07063173 — Bioavailability of Ration Items Containing Tart Cherry Extract · NA · recruiting
- NCT05774704 — Curcumin and Retinal Study · Phase 1, PHASE2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04583722 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Yoav D. Livney
- Last refreshed: 1 April 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04583722.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing