Clinical trial NCT03873909: Bioavailability of Carotenoids Present in Mamey Sapote (Pouteria Sapota (Jacq.) H. E. Moore & Stearn) Fruit
Official title: Bioavailability of Carotenoids Present in Mamey Sapote (Pouteria Sapota (Jacq.) H. E. Moore & Stearn) Fruit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biological Availability
Keywords: Ketocarotenoids
Mamey sapote
Sapotexanthin
Cryptocapsin
Vitamin A
Lead sponsor: University of Hohenheim
Sponsor class: OTHER
Collaborators: name: Universidad de Costa Rica
First posted: 2019-03-14
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomized 2-way cross-over
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in carotenoid concentration in blood plasma over 9.5 h after meal consumption
timeFrame: 7 post-prandial blood samples over 9.5 hours including baseline
measure: Change in retinyl esters concentration in blood plasma over 9.5 h after meal consumption
timeFrame: 7 post-prandial blood samples over 9.5 hours including baseline
Secondary outcomes:
Other outcomes:
Locations:
city: San José
country: Costa Rica
facility: University of Costa Rica
state: San Pedro De Montes De Oca
city: Stuttgart
country: Germany
facility: University of Hohenheim
Study officials:
affiliation: Universidad de Costa Rica
name: Patricia Esquivel, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Costa Rica
name: Silvia Quesada
role: PRINCIPAL_INVESTIGATOR
References: