Biological AvailabilityNCT03873909
Bioavailability of Carotenoids Present in Mamey Sapote (Pouteria Sapota (Jacq.) H. E. Moore & Stearn) Fruit
A study testing Fruit Smoothie and Matrix-Free Shake in people with Biological Availability, run by University of Hohenheim at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Biological Availability
- What is being tested?
- Fruit Smoothie and Matrix-Free Shake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Oct 2017to 13 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult men and women with a BMI 17 to 30
- Aged 18-65 years.
Who cannot join
- 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 locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Costa Rica1 site
University of Costa Rica
San José, San Pedro de Montes de Oca
About this study
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.
Read the 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
- Being tested
- Fruit Smoothie, Matrix-Free Shake
- Keywords
- Ketocarotenoids, Mamey sapote, Sapotexanthin, Cryptocapsin, Vitamin A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruit SmoothieOther
Fruit Smoothie with 150-200 g mamey sapote fruit
Matrix-Free ShakeOther
Shake containing mamey sapote extracted carotenoids (2 g, 845 µg sapotexanthin and 1.21-1.51 mg cryptocapsin
| Study group | Role | What they receive |
|---|---|---|
| Fruit Smoothie | Active comparator | 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). Receives: Other: Fruit Smoothie |
| Matrix-Free Shake | Active comparator | 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. Receives: Other: Matrix-Free Shake |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 post-prandial blood samples over 9.5 hours including baseline
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.
Measured: 7 post-prandial blood samples over 9.5 hours including baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start1 Oct 2017
- Primary completion13 Nov 2017
- Study completion13 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biological AvailabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomized 2-way cross-over
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hohenheim
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Costa Rica
- Responsible party
- Sponsor
- Investigators
- Patricia Esquivel, Ph.D, Principal investigator, Universidad de Costa RicaSilvia Quesada, Principal investigator, Universidad de Costa Rica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873909
- Sponsor's protocol ID
- Sapote2017
- Status last verified
- Mar 2019
- First submitted
- 25 Feb 2019
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Carotenoids Present in Mamey Sapote (Pouteria Sapota (Jacq.) H. E. Moore & Stearn) Fruit
- ClinicalTrials.gov ID
- NCT03873909
- Acronym / sponsor ID
- Sapote2017
- Conditions
- Biological Availability
- Keywords
- Ketocarotenoids, Mamey sapote, Sapotexanthin, Cryptocapsin, Vitamin A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of HohenheimUniversity, hospital or other
- Collaborators
- Universidad de Costa Rica
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 13 Nov 2017 (actual)
- Study completion
- 13 Mar 2018 (actual)
- First posted
- 14 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized 2-way cross-over
| Arm | Type | Receives |
|---|---|---|
| Fruit Smoothie | Active comparator | Other: Fruit SmoothiePost-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). |
| Matrix-Free Shake | Active comparator | Other: Matrix-Free ShakePost-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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy adult men and women with a BMI 17 to 30
- Aged 18-65 years.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fruit SmoothieFruit Smoothie with 150-200 g mamey sapote fruit | Other | Fruit Smoothie |
| Matrix-Free ShakeShake containing mamey sapote extracted carotenoids (2 g, 845 µg sapotexanthin and 1.21-1.51 mg cryptocapsin | Other | Matrix-Free Shake |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Esquivel, Ph.D principal investigator
Universidad de Costa Rica
Silvia Quesada principal investigator
Universidad de Costa Rica
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fruit Smoothie and Matrix-Free Shake in people with Biological Availability, run by University of Hohenheim at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Costa Rica, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2019.