Skip to content

Bioavailability of Carotenoids Present in Mamey Sapote (Pouteria Sapota (Jacq.) H. E. Moore & Stearn) Fruit

Bioavailability of Carotenoids Present in Mamey Sapote (Pouteria Sapota (Jacq.) H. E. Moore & Stearn) Fruit

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03873909
Enrollment
13
Registered
2019-03-14
Start date
2017-10-01
Completion date
2018-03-13
Last updated
2019-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biological Availability

Keywords

Ketocarotenoids, Mamey sapote, Sapotexanthin, Cryptocapsin, Vitamin A

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.

Detailed description

The present study seeks to obtain a better understanding of the bioavailability and metabolism of the exceptional keto-carotenoids, sapotexanthin and cryptocapsin from mamey sapote fruit in humans. For this purpose, the absorption of such carotenoids after the consumption of fresh mamey sapote fruit and a matrix-free water-dispersible formulation containing isolated mamey sapote carotenoids will be compared. The participants of the study will be healthy, non-pregnant, non-smoking adults aged 18-65. Prior to the study, the people who wants to participate in the study will have an education session where the coordinator explains the study in detail and discusses which foods and supplements need to be avoided during the study. They will give their consent to participate in the study, will be screened for body height/weight (BMI) and will complete a health questionnaire. Afterward, if they fit the necessary health criteria for the study, they will be enrolled as a participant and an appointment will be made for their post-prandial visit to the School of Medicine (University of Costa Rica). The participants will refrain from consuming products containing high levels of carotenoids (β-carotene, β-cryptoxanthin, lutein, and zeaxanthin) for 10 days prior to the first day of treatment until the end of the study (washout). They will receive a list of foods and supplements to avoid. They will record their actual daily consumption of carotenoid-containing foods on the list of foods to avoid. The record will allow determining whether participants are remaining compliant and avoiding carotenoid-containing foods. For the post-prandial visit, a blood sample will be taken at hour 0 (baseline sample) and then the corresponding test meal (fruit smoothie or matrix-free shake) will be administered to the participants. Subsequent blood sampling will be carried out at 2,4,5,6,8 and 9.5 h after the meal is consumed. A carotenoid-free lunch will be provided at 4.5 hours. Afterward, the triglyceride-rich fraction (TRL) will be isolated from the plasma samples and the concentration of carotenoids and retinyl esters determined. The values obtained will be used to determine the mean value of the Area Under the Curve (AUC) through time to compare the absorption between the two meals provided.

Interventions

Fruit Smoothie with 150-200 g mamey sapote fruit

OTHERMatrix-Free Shake

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

Sponsors

Universidad de Costa Rica
CollaboratorOTHER
University of Hohenheim
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

randomized 2-way cross-over

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in carotenoid concentration in blood plasma over 9.5 h after meal consumption7 post-prandial blood samples over 9.5 hours including baselineAn 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.
Change in retinyl esters concentration in blood plasma over 9.5 h after meal consumption7 post-prandial blood samples over 9.5 hours including baselineAn 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.

Countries

Costa Rica, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026