NCT03873909

Brief Summary

The goal of the study is to determine if mamey sapote fruit, rich in rare potentially provitamin A keto-carotenoids, is a good source of vitamin A in humans. Furthermore, it will help to compare the absorption of carotenoids between the fruit versus a "matrix-free" formulation. The objective will be accomplished by quantitation of the immediate post-prandial plasma concentrations of parent carotenoids and vitamin A metabolites from participants consuming a meal consisting of a mamey sapote fruit smoothie or a shake containing mamey sapote encapsulated carotenoids.

Trial Health

90
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 Oct 2017

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 14, 2019

Completed
Last Updated

March 14, 2019

Status Verified

March 1, 2019

Enrollment Period

1 month

First QC Date

February 25, 2019

Last Update Submit

March 12, 2019

Conditions

Biological Availability

Keywords

KetocarotenoidsMamey sapoteSapotexanthinCryptocapsinVitamin A

Outcome Measures

Primary Outcomes (2)

  • Change in carotenoid concentration in blood plasma over 9.5 h after meal consumption

    An area under the curve for concentration of carotenoids (from triglyceride-rich lipoprotein (TRL) fraction of plasma) will be obtained by using carotenoid concentrations from hours 0, 2, 4, 5, 6, 8 and 9.5 over time to quantify absorption after subjects consume a meal consisting of a mamey sapote fruit smoothie or a "matrix-free" carotenoid-rich shake.

    7 post-prandial blood samples over 9.5 hours including baseline

  • Change in retinyl esters concentration in blood plasma over 9.5 h after meal consumption

    An area under the curve for concentration of retinyl esters (from triglyceride-rich lipoprotein (TRL) fraction of plasma) will be obtained by using retinyl esters concentrations from hours 0, 2, 4, 5, 6, 8 and 9.5 over time to quantify conversion of carotenoids to retinyl esters after subjects consume a meal consisting of a mamey sapote fruit smoothie or a "matrix-free" carotenoid-rich shake.

    7 post-prandial blood samples over 9.5 hours including baseline

Study Arms (2)

Fruit Smoothie

ACTIVE COMPARATOR

Post-prandial study feeding 155-200 g mamey sapote mesocarp, 6 g of soybean oil , crushed ice and 150-200 g of water to reach a total volume of 450 mL. (845 µg sapotexanthin, 1.21-1.51 mg cryptocapsin).

Other: Fruit Smoothie

Matrix-Free Shake

ACTIVE COMPARATOR

Post-prandial study feeding 2 g of carotenoid powder formula (845 µg sapotexanthin, 1.21-1.51 mg cryptocapsin), 37.5 g of sugar, 75 µg of citric acid, 6 g of soybean oil emulsified into 300 g of water using 3 g of soy lecithin as well as ca. 100 g of crushed ice, yielding a shake volume of 450 mL.

Other: Matrix-Free Shake

Interventions

Fruit SmoothieOTHER

Fruit Smoothie with 150-200 g mamey sapote fruit

Fruit Smoothie
Matrix-Free ShakeOTHER

Shake containing mamey sapote extracted carotenoids (2 g, 845 µg sapotexanthin and 1.21-1.51 mg cryptocapsin

Matrix-Free Shake

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adult men and women with a BMI 17 to 30
  • Aged 18-65 years.

You may not qualify if:

  • lactating, pregnant, or planned to be pregnant
  • smokers/those who use tobacco products
  • metabolic or malabsorption disorders
  • with history of cancer
  • with history of liver insufficiency or other gastro-intestinal diseases
  • with history of chronic diseases related to lipid metabolism
  • obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Costa Rica

San José, San Pedro de Montes de Oca, Costa Rica

Location

University of Hohenheim

Stuttgart, Germany

Location

Study Officials

  • Patricia Esquivel, Ph.D

    Universidad de Costa Rica

    PRINCIPAL INVESTIGATOR

  • Silvia Quesada

    Universidad de Costa Rica

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: randomized 2-way cross-over
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2019

First Posted

March 14, 2019

Study Start

October 1, 2017

Primary Completion

November 13, 2017

Study Completion

March 13, 2018

Last Updated

March 14, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)CO(1)