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

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ClinicalTrials.gov Identifier: NCT03873909
Recruitment Status : Completed
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Collaborator:
Universidad de Costa Rica
Information provided by (Responsible Party):
University of Hohenheim

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.


Condition or disease Intervention/treatment Phase
Biological Availability Other: Fruit Smoothie Other: Matrix-Free Shake Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
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Costa Rica
University of Costa Rica
San José, San Pedro De Montes De Oca, Costa Rica
Germany
University of Hohenheim
Stuttgart, Germany
Sponsors and Collaborators
University of Hohenheim
Universidad de Costa Rica
Investigators
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Principal Investigator: Patricia Esquivel, Ph.D Universidad de Costa Rica
Principal Investigator: Silvia Quesada Universidad de Costa Rica

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Responsible Party: University of Hohenheim
ClinicalTrials.gov Identifier: NCT03873909     History of Changes
Other Study ID Numbers: Sapote2017
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Hohenheim:
Ketocarotenoids
Mamey sapote
Sapotexanthin
Cryptocapsin
Vitamin A
Additional relevant MeSH terms:
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Sapotexanthin
Carotenoids
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Provitamins
Vitamins
Micronutrients
Nutrients
Growth Substances