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

University of Hohenheim

Status: Completed

Conditions: Biological Availability

Treatments: Other: Fruit Smoothie; Other: Matrix-Free Shake

Study type: Interventional

Funder types: Other

Identifiers

NCT03873909

Sapote2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Fruit Smoothie

Active Comparator group

Description:

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).

Treatment:

Other: Fruit Smoothie

Matrix-Free Shake

Active Comparator group

Description:

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.

Treatment:

Other: Matrix-Free Shake