Healthy VolunteersEarly Phase 1METABORANGENCT02685124
Metabolomic Approach to Evaluate the Effect of Orange Juice Intake in Healthy Humans (METABORANGE).
A Early Phase 1 study testing Orange juice in people with Healthy Volunteers, run by University of Sao Paulo.
Trial summary
This study evaluates the effect of intake of two orange juice varieties in healthy adults. The participants will receive "Bahia" orange juice, "Cara-Cara" orange juice or a isocaloric control drink in a cross-over study. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Orange juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Feb 2016
- Phase
- Early Phase 1
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects like to drink orange juice
Who cannot join
- History of cardiovascular disease
- History of gastrointestinal, liver or kidney disease
- History of alcoholism
- Diabetes and metabolic diseases
- Pregnant, trying to became pregnant or breast feeding
- Smokers
- To make use of vitamin and mineral supplements, antibiotics, antiacids, any drugs
About this study
Official title: Metabolomic Approach to Evaluate the Effect of Orange Juice Intake in Healthy Humans: a Comparative Study Between "Bahia" and "Cara Cara" Orange Varieties.
This study evaluates the effect of intake of two orange juice varieties in healthy adults. The participants will receive "Bahia" orange juice, "Cara-Cara" orange juice or a isocaloric control drink in a cross-over study.
Read the detailed description
The consumption of fruits and vegetables is linked to a decrease in the incidence of chronic diseases. Citrus fruits represent the main source of bioactive compounds such as flavonoids, vitamin C and carotenoids in the brazilian diet.
Unlike the "Bahia", the "Cara Cara" variety which is a spontaneous mutation of "Washington navel" orange is characterized by a bright red pulp due to high levels of lycopene. This difference in the chemical composition may lead to a different biological activity and then a greater protective effect on health.
Since the biological effects generated from a food intake are the result of the interaction of various nutrients with different metabolic pathways, the investigators will apply the metabolomic approach to investigate the complex relationships between fruit intake, bioactive compounds and human metabolism. The investigators will propose to describe the metabolic pathways affected by orange juice intake and to identify biomarkers that can be used in nutritional interventions.
- Conditions
- Healthy Volunteers
- Being tested
- Orange juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orange juiceDietary supplement
Three days before the start of the study, all participants will restrict their diet avoiding citrus fruits (orange, tangerine, lemon) and its derivatives (washout period), red fruits and vegetables (strawberry, red lettuce, red grape, tomate). The day before the sample collection will be provided a controlled dinner. A fasting for 8 hours will be required before blood and urine collection. All participants will divided into three groups: I (Cara Cara), II (Bahia), III (Isocaloric control drink). They will consume 250 ml of each drink twice daily for 7 consecutive days, with a washout period of 7 days among each intervention.
| Study group | Role | What they receive |
|---|---|---|
| Bahia orange juice | Experimental | 250 ml twice daily for 7 days Receives: Dietary Supplement: Orange juice |
| Cara Cara orange juice | Experimental | 250 ml twice daily for 7 days Receives: Dietary Supplement: Orange juice |
| Isocaloric control drink | Placebo comparator | 250 ml twice daily for 7 days Receives: Dietary Supplement: Orange juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative changes in urinary metabolome will be evaluated by Gas Chromatography coupled to Mass Spectrometry (GC-MS) and Liquid Chromatography coupled to Mass Spectrometry (LC-MS).
Measured: Urine collection will be performed at time 0, after 3, 6 hours and 7 days of treatment.
Secondary outcomes (3)
Changes in the antioxidant enzymes will be evaluated in serum samples in different time points.
Measured: Blood collection will be performed at time 0, after 3, 6 hours and 7 days of treatment
Changes in the miRNAs expression will be evaluated in plasma samples in different time points.
Measured: Blood collection will be performed at time 0, after 3, 6 hours and 7 days of treatment
Qualitative and quantitative changes in fecal metabolome will be evaluated by an untargeted metabolomic approach based on Nuclear Magnetic Resonance spectroscopy (NMR).
Measured: Feces collection will be performed at time 0 and after 7 days of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study startSep 2015
- Primary completionOct 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisa Brasili, University of Sao Paulo
- Investigators
- Elisa Brasili, PhD, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685124
- Sponsor's protocol ID
- CEP FCF 1097907
- Acronym
- METABORANGE
- Status last verified
- Feb 2016
- First submitted
- 4 Feb 2016
- Last updated
- 18 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: February 2017
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomic Approach to Evaluate the Effect of Orange Juice Intake in Healthy Humans: a Comparative Study Between "Bahia" and "Cara Cara" Orange Varieties.
- ClinicalTrials.gov ID
- NCT02685124
- Acronym / sponsor ID
- METABORANGE / CEP FCF 1097907
- Conditions
- Healthy Volunteers
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 18 Feb 2016 (estimated)
- 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.
This study evaluates the effect of intake of two orange juice varieties in healthy adults. The participants will receive "Bahia" orange juice, "Cara-Cara" orange juice or a isocaloric control drink in a cross-over study.
Detailed description
The consumption of fruits and vegetables is linked to a decrease in the incidence of chronic diseases. Citrus fruits represent the main source of bioactive compounds such as flavonoids, vitamin C and carotenoids in the brazilian diet.
Unlike the "Bahia", the "Cara Cara" variety which is a spontaneous mutation of "Washington navel" orange is characterized by a bright red pulp due to high levels of lycopene. This difference in the chemical composition may lead to a different biological activity and then a greater protective effect on health.
Since the biological effects generated from a food intake are the result of the interaction of various nutrients with different metabolic pathways, the investigators will apply the metabolomic approach to investigate the complex relationships between fruit intake, bioactive compounds and human metabolism. The investigators will propose to describe the metabolic pathways affected by orange juice intake and to identify biomarkers that can be used in nutritional interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bahia orange juice | Experimental | Dietary Supplement: Orange juice250 ml twice daily for 7 days |
| Cara Cara orange juice | Experimental | Dietary Supplement: Orange juice250 ml twice daily for 7 days |
| Isocaloric control drink | Placebo comparator | Dietary Supplement: Orange juice250 ml twice daily for 7 days |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects like to drink orange juice
Key exclusion criteria (7 listed)
- History of cardiovascular disease
- History of gastrointestinal, liver or kidney disease
- History of alcoholism
- Diabetes and metabolic diseases
- Pregnant, trying to became pregnant or breast feeding
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 juiceThree days before the start of the study, all participants will restrict their diet avoiding citrus fruits (orange, tangerine, lemon) and its derivatives (washout period), red fruits and vegetables (strawberry, red lettuce, red grape, tomate). The day before the sample collection will be provided a controlled dinner. A fasting for 8 hours will be required before blood and urine collection. All participants will divided into three groups: I (Cara Cara), II (Bahia), III (Isocaloric control drink). They will consume 250 ml of each drink twice daily for 7 consecutive days, with a washout period of 7 days among each intervention. | Dietary supplement | Bahia orange juice, Cara Cara orange juice, Isocaloric control drink |
Primary outcome
Qualitative changes in urinary metabolome will be evaluated by Gas Chromatography coupled to Mass Spectrometry (GC-MS) and Liquid Chromatography coupled to Mass Spectrometry (LC-MS).
Time frame: Urine collection will be performed at time 0, after 3, 6 hours and 7 days of treatment.
3 secondary outcomes
Changes in the antioxidant enzymes will be evaluated in serum samples in different time points.
Time frame: Blood collection will be performed at time 0, after 3, 6 hours and 7 days of treatment
Changes in the miRNAs expression will be evaluated in plasma samples in different time points.
Time frame: Blood collection will be performed at time 0, after 3, 6 hours and 7 days of treatment
Qualitative and quantitative changes in fecal metabolome will be evaluated by an untargeted metabolomic approach based on Nuclear Magnetic Resonance spectroscopy (NMR).
Time frame: Feces collection will be performed at time 0 and after 7 days of treatment.
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 18 Feb 2016.
- Individual participant dataSharing planned: Yes. February 2017
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Screening Protocol
Pain
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.
Elisa Brasili, PhD study director
University of Sao Paulo
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Orange juice in people with Healthy Volunteers, run by University of Sao Paulo.
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 1 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 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Qualitative changes in urinary metabolome will be evaluated by Gas Chromatography coupled to Mass Spectrometry (GC-MS) and Liquid Chromatography coupled to Mass Spectrometry (LC-MS). (time frame: Urine collection will be performed at time 0, after 3, 6 hours and 7 days of treatment.). 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 18 Feb 2016.