Bioavailability of Carotenoids Present in Mamey Sapote (Pouteria Sapota (Jacq.) H. E. Moore & Stearn) Fruit
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03873909|
Recruitment Status : Completed
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Biological Availability||Other: Fruit Smoothie Other: Matrix-Free Shake||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||randomized 2-way cross-over|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Bioavailability of Carotenoids Present in Mamey Sapote (Pouteria Sapota (Jacq.) H. E. Moore & Stearn) Fruit|
|Actual Study Start Date :||October 1, 2017|
|Actual Primary Completion Date :||November 13, 2017|
|Actual Study Completion Date :||March 13, 2018|
Active Comparator: 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).
Other: Fruit Smoothie
Fruit Smoothie with 150-200 g mamey sapote fruit
Active Comparator: 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.
Other: Matrix-Free Shake
Shake containing mamey sapote extracted carotenoids (2 g, 845 µg sapotexanthin and 1.21-1.51 mg cryptocapsin
- Change in carotenoid concentration in blood plasma over 9.5 h after meal consumption [ Time Frame: 7 post-prandial blood samples over 9.5 hours including baseline ]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.
- Change in retinyl esters concentration in blood plasma over 9.5 h after meal consumption [ Time Frame: 7 post-prandial blood samples over 9.5 hours including baseline ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873909
|University of Costa Rica|
|San José, San Pedro De Montes De Oca, Costa Rica|
|University of Hohenheim|
|Principal Investigator:||Patricia Esquivel, Ph.D||Universidad de Costa Rica|
|Principal Investigator:||Silvia Quesada||Universidad de Costa Rica|