NCT04583722

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2019

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 12, 2020

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

5 months

First QC Date

October 5, 2020

Last Update Submit

March 30, 2021

Conditions

Bioavailability

Keywords

AstaxanthinBioavailabilityEncapsulationPotato proteinOlive oil

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

AX oleoresin

OTHER

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

Dietary Supplement: AX-olive oil-PP emulsion

AX-olive oil-PP emulsion

EXPERIMENTAL

Microencapsulated AX (1%:2%:3% (AXO:OO:PP, %w/v ratio) + 0.15% maltodextrin). 15 mg AX (in 4 pululan capsules)

Dietary Supplement: AX-olive oil-PP emulsion

Interventions

AX-olive oil-PP emulsionDIETARY_SUPPLEMENT

single dose and plasma samples

Also known as: (control- raw AXoleoresin)
AX oleoresinAX-olive oil-PP emulsion

Eligibility Criteria

Age18 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers
  • Aged 18 - 26
  • Normal physical examination
  • Normal electrocardiogram (E.C.G.)
  • Normal laboratory profile

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Campus

Haifa, Israel

Location

Related 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.

    BACKGROUND

Related Links

Study Officials

  • Elena Segal, Doctor

    Endocrine Institute, Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

October 5, 2020

First Posted

October 12, 2020

Study Start

July 15, 2018

Primary Completion

November 30, 2018

Study Completion

January 16, 2019

Last Updated

April 1, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)