Biological Availability Clinical Trial
Official title:
Bioavailability of Carotenoids Present in Mamey Sapote (Pouteria Sapota (Jacq.) H. E. Moore & Stearn) Fruit
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.
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.
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