Bioavailability of Carotenoids Present in Mamey Sapote (Pouteria Sapota (Jacq.) H. E. Moore & Stearn) Fruit
Condition: Biological Availability
Study type: Interventional

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.
    

Intervention name(s): Fruit Smoothie; Matrix-Free Shake
Intervention type(s): Other; Other
Intervention description(s): Fruit Smoothie with 150-200 g mamey sapote fruit; Shake containing mamey sapote extracted carotenoids (2 g, 845 µg sapotexanthin and 1.21-1.51 mg cryptocapsin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: randomized 2-way cross-over
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Ketocarotenoids; Mamey sapote; Sapotexanthin; Cryptocapsin; Vitamin A