Biological AvailabilityNCT04744233
Bioavailability of Carotenoids From Orange Juice in a Cross-over Study in Healthy Subjects.
A study testing Orange juice in people with Biological Availability and Carotenoids, run by Instituto de Ciencia y Tecnología de Alimentos y Nutrición at 2 sites in Spain.
Trial summary
Commercially available fruit juices are obtained after applying industrial technologies to preserve and extend the shelf-life by inactivation of microorganism and enzymes. These are traditional thermal treatment (eg. Read more about this study
- Who is it for?
- Ages 20 to 32 yearsHealthy volunteers can take part
- Conditions the study is for
- Biological Availability, Carotenoids, Lutein
- What is being tested?
- Orange juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesSpain
- Study dates
- Oct 2001to Nov 2002
- 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 20 to 32 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age (20- 32 y)
- body mass index (BMI)
- serum cholesterol and triglycerides concentrations within the normal range
- serum retinol within the range 31 - 70 µg/dL.
Who cannot join
- vitamin / mineral supplements intake
- regular medication
- pregnancy or lactating
- chronic disease
- smoking habit.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Effect of Traditional and Emerging Conservation Technologies on Bioactive Compounds and Their Antioxidant Capacity in Plant Foods
Commercially available fruit juices are obtained after applying industrial technologies to preserve and extend the shelf-life by inactivation of microorganism and enzymes. These are traditional thermal treatment (eg. pasteurization, sterilization) that causes losses of nutritional and bioactive compounds, changes physicochemical properties (colour, flavor and texture) and can modify their bioavailabilities. Thus, the traditional thermal processing is being replaced by less intense thermal technologies (e.g. low-temperature pasteurization / refrigerated storage) and non-thermal treatments such as the high-pressure processing (HPP) and the pulsed electric fields (PEF) as an alternative to enhace food safety and shelf-life without compromising organoleptic qualities (retain the flavour, color healthiness of fresh foods) and keeping their health-promoting capacity. The beneficial health effect derived from the orange juice intake is partly related to the bioavailability of their bioactive compounds.
The aim of this study was to assess the effect of the intake of freshly squeezed orange juice (Citrus sinensis L.) and processed orange juice elaborated with different treatments (low pasteurization / refrigerated storage, high-pressure processing, pulsed electric fields) on the main serum carotenoid concentrations in a cross-over study in apparently healthy subjects using multiple dosis.
Read the detailed description
Methods Twelve healthy subjects (6 men), age 20-32 y, were enrolled in a cross-over study, to consume 500 mL of orange juice/day during 14 days periods. All volunteers consumed the LP and HPP, six consumed PEF or FS-orange juice. Fasted blood was collected at baseline and on days 7 and 14. Carotenoid concentrations in serum and orange juice were analyzed by high performance liquid chromatogry (HPLC).
- Conditions
- Biological Availability, Carotenoids, Lutein, Humans
- Being tested
- Orange juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orange juiceOther
Subjects were enrolled to consume 500 mL of orange juice/day during three consecutive 14 days periods separated by 1 - 1.5 month washouts. The orange juices assayed were: freshly squeezed (FS), commercially available low pasteurized juice (LP) and juices treated by high-pressure processing (HPP) and by pulsed electric fields (PEF). All participants consumed the LP and the HPP orange juices. Six subjects consumed PEF-orange juice and other six consumed the FS-orange juice.
| Study group | Role | What they receive |
|---|---|---|
| Freshly squeezed orange juice (FS) | Active comparator | Subjects were enrolled to consume 500 mL of orange juice/day during three consecutive 14 days periods separated by 1 - 1.5 month washouts. The orange juice assayed was freshly squeezed (FS). Six subjects consumed FS-orange juice. Receives: Other: Orange juice |
| Commercially available low pasteurized orange juice (LP) | Active comparator | Subjects were enrolled to consume 500 mL of orange juice/day during three consecutive 14 days periods separated by 1 - 1.5 month washouts. The orange juices assayed was commercially available low pasteurized juice (LP). All participants consumed the LP orange juices. Receives: Other: Orange juice |
| High-pressure processed orange juice(HPP) | Active comparator | Subjects were enrolled to consume 500 mL of orange juice/day during three consecutive 14 days periods separated by 1 - 1.5 month washouts. The orange juices assayed was high-pressure processed (HPP). All participants consumed the HPP orange juices. Receives: Other: Orange juice |
| Pulsed electric fields treated orange juice (PEF) | Active comparator | Subjects were enrolled to consume 500 mL of orange juice/day during three consecutive 14 days periods separated by 1 - 1.5 month washouts. The orange juices assayed was those treated with pulsed electric fields (PEF). Six participants consumed the PEF-orange juice. Receives: Other: Orange juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the effect of dairy intake of orange juice elaborated with four different procedures on the serum carotenoid concentrations of healthy adults.
Assessment of the effect of dairy intake of orange juice elaborated with low temperature pasterurization (LP), high-pressure processing (HPP), pulsed electric fields (PEF) and freshly squeezd (FS) on the serum carotenoid concentrations of healthy adults.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study startOct 2001
- Primary completionJun 2002
- Study completionNov 2002
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
- Non-randomised
- Intervention model
- Crossover
- Model description
- Multiple dose cross-over study.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Ciencia y Tecnología de Alimentos y Nutrición
- Sponsor type
- Other government
- Collaborators
- Comunidad de Madrid, Instituto de Salud Carlos III, Puerta de Hierro University Hospital
- Responsible party
- Principal investigator, Begoña Olmedilla, Instituto de Ciencia y Tecnología de Alimentos y Nutrición
- Investigators
- Olmedilla-Alonso, Principal investigator, Instituto de Ciencia y Tecnología de Alimentos y Nutrición
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744233
- Sponsor's protocol ID
- CAM-HUPH-IF
- Status last verified
- Feb 2021
- First submitted
- 27 Jan 2021
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Traditional and Emerging Conservation Technologies on Bioactive Compounds and Their Antioxidant Capacity in Plant Foods
- ClinicalTrials.gov ID
- NCT04744233
- Acronym / sponsor ID
- CAM-HUPH-IF
- Conditions
- Biological Availability, Carotenoids, Lutein, Humans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Instituto de Ciencia y Tecnología de Alimentos y NutriciónOther government
- Collaborators
- Comunidad de Madrid, Instituto de Salud Carlos III, Puerta de Hierro University Hospital
- Study start
- Oct 2001 (actual)
- Primary completion
- Jun 2002 (actual)
- Study completion
- Nov 2002 (actual)
- First posted
- 8 Feb 2021 (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.
Commercially available fruit juices are obtained after applying industrial technologies to preserve and extend the shelf-life by inactivation of microorganism and enzymes. These are traditional thermal treatment (eg. pasteurization, sterilization) that causes losses of nutritional and bioactive compounds, changes physicochemical properties (colour, flavor and texture) and can modify their bioavailabilities. Thus, the traditional thermal processing is being replaced by less intense thermal technologies (e.g. low-temperature pasteurization / refrigerated storage) and non-thermal treatments such as the high-pressure processing (HPP) and the pulsed electric fields (PEF) as an alternative to enhace food safety and shelf-life without compromising organoleptic qualities (retain the flavour, color healthiness of fresh foods) and keeping their health-promoting capacity. The beneficial health effect derived from the orange juice intake is partly related to the bioavailability of their bioactive compounds.
The aim of this study was to assess the effect of the intake of freshly squeezed orange juice (Citrus sinensis L.) and processed orange juice elaborated with different treatments (low pasteurization / refrigerated storage, high-pressure processing, pulsed electric fields) on the main serum carotenoid concentrations in a cross-over study in apparently healthy subjects using multiple dosis.
Detailed description
Methods Twelve healthy subjects (6 men), age 20-32 y, were enrolled in a cross-over study, to consume 500 mL of orange juice/day during 14 days periods. All volunteers consumed the LP and HPP, six consumed PEF or FS-orange juice. Fasted blood was collected at baseline and on days 7 and 14. Carotenoid concentrations in serum and orange juice were analyzed by high performance liquid chromatogry (HPLC).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Multiple dose cross-over study.
| Arm | Type | Receives |
|---|---|---|
| Freshly squeezed orange juice (FS) | Active comparator | Other: Orange juiceSubjects were enrolled to consume 500 mL of orange juice/day during three consecutive 14 days periods separated by 1 - 1.5 month washouts. The orange juice assayed was freshly squeezed (FS). Six subjects consumed FS-orange juice. |
| Commercially available low pasteurized orange juice (LP) | Active comparator | Other: Orange juiceSubjects were enrolled to consume 500 mL of orange juice/day during three consecutive 14 days periods separated by 1 - 1.5 month washouts. The orange juices assayed was commercially available low pasteurized juice (LP). All participants consumed the LP orange juices. |
| High-pressure processed orange juice(HPP) | Active comparator | Other: Orange juiceSubjects were enrolled to consume 500 mL of orange juice/day during three consecutive 14 days periods separated by 1 - 1.5 month washouts. The orange juices assayed was high-pressure processed (HPP). All participants consumed the HPP orange juices. |
| Pulsed electric fields treated orange juice (PEF) | Active comparator | Other: Orange juiceSubjects were enrolled to consume 500 mL of orange juice/day during three consecutive 14 days periods separated by 1 - 1.5 month washouts. The orange juices assayed was those treated with pulsed electric fields (PEF). Six participants consumed the PEF-orange juice. |
Who may qualify
- Ages
- 20 to 32 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age (20- 32 y)
- body mass index (BMI)
- serum cholesterol and triglycerides concentrations within the normal range
- serum retinol within the range 31 - 70 µg/dL.
Key exclusion criteria (5 listed)
- vitamin / mineral supplements intake
- regular medication
- pregnancy or lactating
- chronic disease
- smoking habit.
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 |
|---|---|---|
| Orange juiceSubjects were enrolled to consume 500 mL of orange juice/day during three consecutive 14 days periods separated by 1 - 1.5 month washouts. The orange juices assayed were: freshly squeezed (FS), commercially available low pasteurized juice (LP) and juices treated by high-pressure processing (HPP) and by pulsed electric fields (PEF). All participants consumed the LP and the HPP orange juices. Six subjects consumed PEF-orange juice and other six consumed the FS-orange juice. | Other | Commercially available low pasteurized orange juice (LP), Freshly squeezed orange juice (FS), High-pressure processed orange juice(HPP), Pulsed electric fields treated orange juice (PEF) |
Primary outcome
Assessment of the effect of dairy intake of orange juice elaborated with four different procedures on the serum carotenoid concentrations of healthy adults.
Time frame: 6 months
Assessment of the effect of dairy intake of orange juice elaborated with low temperature pasterurization (LP), high-pressure processing (HPP), pulsed electric fields (PEF) and freshly squeezd (FS) on the serum carotenoid concentrations of healthy adults.
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 9 Feb 2021.
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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.
Olmedilla-Alonso principal investigator
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orange juice in people with Biological Availability and Carotenoids, run by Instituto de Ciencia y Tecnología de Alimentos y Nutrición at 2 sites in Spain.
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 4 inclusion and 5 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 9 Feb 2021. 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 Spain. 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?
Assessment of the effect of dairy intake of orange juice elaborated with four different procedures on the serum carotenoid concentrations of healthy adults. (time frame: 6 months). 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 9 Feb 2021.