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

Biological Availability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03873909
• Other study ID #: Sapote2017
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: March 13, 2018

Study information

• Verified date: March 2019
• Source: University of Hohenheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 13, 2018
• Est. primary completion date: November 13, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Biological Availability

Intervention

Other:
• Fruit Smoothie
Fruit Smoothie with 150-200 g mamey sapote fruit
• Matrix-Free Shake
Shake containing mamey sapote extracted carotenoids (2 g, 845 µg sapotexanthin and 1.21-1.51 mg cryptocapsin

Locations

Country	Name	City	State
Costa Rica	University of Costa Rica	San José	San Pedro De Montes De Oca
Germany	University of Hohenheim	Stuttgart

Sponsors (2)

Lead Sponsor	Collaborator
University of Hohenheim	Universidad de Costa Rica

Countries where clinical trial is conducted

Costa Rica,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in carotenoid concentration in blood plasma over 9.5 h after meal consumption	An area under the curve for concentration of carotenoids (from triglyceride-rich lipoprotein (TRL) fraction of plasma) will be obtained by using carotenoid concentrations from hours 0, 2, 4, 5, 6, 8 and 9.5 over time to quantify absorption after subjects consume a meal consisting of a mamey sapote fruit smoothie or a "matrix-free" carotenoid-rich shake.	7 post-prandial blood samples over 9.5 hours including baseline
Primary	Change in retinyl esters concentration in blood plasma over 9.5 h after meal consumption	An area under the curve for concentration of retinyl esters (from triglyceride-rich lipoprotein (TRL) fraction of plasma) will be obtained by using retinyl esters concentrations from hours 0, 2, 4, 5, 6, 8 and 9.5 over time to quantify conversion of carotenoids to retinyl esters after subjects consume a meal consisting of a mamey sapote fruit smoothie or a "matrix-free" carotenoid-rich shake.	7 post-prandial blood samples over 9.5 hours including baseline