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

NCT ID: NCT03873909

Last Updated: 2019-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2018-03-13

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.

Conditions

Biological Availability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Fruit Smoothie

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).

Group Type: ACTIVE_COMPARATOR

Fruit Smoothie

Intervention Type: OTHER

Fruit Smoothie with 150-200 g mamey sapote fruit

Matrix-Free Shake

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.

Group Type: ACTIVE_COMPARATOR

Matrix-Free Shake

Intervention Type: OTHER

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

Interventions

Fruit Smoothie

Fruit Smoothie with 150-200 g mamey sapote fruit

Intervention Type: OTHER

Matrix-Free Shake

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad de Costa Rica

OTHER

Sponsor Role: collaborator

University of Hohenheim

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patricia Esquivel, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Universidad de Costa Rica

Silvia Quesada

Role: PRINCIPAL_INVESTIGATOR

Universidad de Costa Rica

Locations

University of Costa Rica

San José, San Pedro de Montes de Oca, Costa Rica

University of Hohenheim

Stuttgart, , Germany

Countries

Costa Rica; Germany

Other Identifiers

Sapote2017

Identifier Type: -

Identifier Source: org_study_id