Blood PressureFLAVOTIPNCT04234100
Bioavailability of Hesperidine and Narirutin From Orange Juice to Identify Metabotypes in Hypertension
A study testing Orange juice rich in hesperidin and narirutin in people with Blood Pressure and Hypertension, run by Technological Centre of Nutrition and Health, Spain at 1 site in Spain.
Trial summary
Flavonoids are polyphenolic compound mainly found in fruits and vegetables with numerous beneficial health effects as protection against cardiovascular diseases by an antihypertensive effect. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Hypertension
- What is being tested?
- Orange juice rich in hesperidin and narirutin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteSpain
- Study dates
- 24 Feb 2020to 22 Sep 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women over 18 years of age
- Systolic blood pressure ≤159 mm Hg
- Sign the informed consent
Who cannot join
- Body mass index (BMI) ≥ 35 kg / m2
- Glucose > 126 mg / dL
- Systolic blood pressure ≥ 160 mm Hg and diastolic blood pressure > 100 mm Hg or taking antihypertensive drugs
- LDL cholesterol > 189 mg / dL
- Triglycerides > 350 mg / dL
- Anemia (hemoglobin ≤ 13 g / dL in men and ≤ 12 g / dL in women)
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- Tobacco addiction
- Consumption of medicines, antioxidants or vitamin supplements 30 days before the study
- Use of antibiotics during the last 30 days prior to the study
- Consumption of prebiotics and / or probiotics during the 30 days prior to the study
- Clinical history of gastrointestinal disease or presence of intestinal disorders at the time of inclusion
- Chronic alcoholism
- Monitoring a vegetarian diet
- Pregnant or with intent to get pregnant
- Being in breastfeeding period
- Participation in a clinical trial or nutritional intervention study, in the last 30 days.
- Inability to follow the study guidelines
Trial locations and contacts
1 site in 1 country.
Spain1 site
Centro Tecnológico de Nutrición y Salud (Eurecat-Reus)
Reus, Tarragona
About this study
Official title: Study of the Bioavailability of Hesperidine and Narirutin Provided by an Orange Juice to Identify Various Metabotypes in Prehypertensive and Hypertensive Grade 1 Individuals (FLAVOTIP)
Flavonoids are polyphenolic compound mainly found in fruits and vegetables with numerous beneficial health effects as protection against cardiovascular diseases by an antihypertensive effect. The intestinal microbiota plays a key role in the metabolization of these compounds, so that differences in the composition and activity of the microbiota between individuals can generate different metabotypes. Flavonoids are found mainly in their conjugated form linked to the monosaccharide rhamnose and need to be metabolized by the intestinal bacteria, releasing the rhamnose, to be absorbed and, thus, bioactive. The bacterial enzyme responsible of rhamnose hydrolysis is α-L-rhamnosidase, whose activity can vary considerably depending on the composition of the microbiota. In fact, a great interindividual variability has been observed in the ability to absorb flavonoids, which allows to classify individuals according to the corresponding metabotype. In a previous project, the investigators confirmed the interindividual differences in the bioavailability of hesperidin and narirutin, two flavonoids naturally present in orange juice. However, the role of the intestinal microbiota in the metabolism of hesperidin and narirutin needs to be elucidated.
On this basis, the following hypothesis is presented: individuals with arterial hypertension can be classified into 3 different metabotypes that are the result of the ability to absorb hesperidin and narirutin, determined by the urinary excretion of their respective metabolites, and these metabotypes are associated with different microbiota enterotypes and with different fecal α-L-rhamnosidase activity.
- Conditions
- Blood Pressure, Hypertension
- Being tested
- Orange juice rich in hesperidin and narirutin
- Keywords
- Hypertension, Flavonoids, Orange juice, Metabotypes
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orange juice rich in hesperidin and narirutinOther
The product is a concentrated orange juice provided by the CITRUS Department of Florida (USA: www.FloridaCitrus.org).
| Study group | Role | What they receive |
|---|---|---|
| Orange juice rich in hesperidin and narirutin | Experimental | The consumption of the orange juice will be made in a single dose of 500 ml. The juice is presented in a concentrated and frozen format, packed in opaque cans of 500 mL, for which it must be thawed and diluted with mineral water up to 1.5 L before its ingestion. Receives: Other: Orange juice rich in hesperidin and narirutin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of absorption of hesperidin and narirutin
Quantification of the metabolites derived from hesperidin and narirutin in basal and 24-hour urine samples, using Liquid Chromatography coupled to Mass Spectrometry (LC-QqQ).
From the profile of metabolites detected in urine, the percentage of absorption of hesperidin and narirutin with respect to the amount ingested will be quantified to determine the metabotypes, based on the urinary excretion corresponding to each volunteer:
Measured: After 24 hours of juice consumption
Secondary outcomes (4)
Fecal α-L-rhamnosidase activity
Quantification of α-L-rhamnosidase activity in fecal samples by incubation of the samples with the substrate p-nitrophenyl α-Lrhamnopyranoside and the subsequent measurement of the aborsbance to a length wavelength of 405 nM in a spectrophotometer.
Measured: Basal
Gut microbiota composition
Metagenomic analysis in fecal samples. The bacteria DNA will be extracted and massive sequenced by the Ion Torrent platform.
The relative abundances of the different bacterial populations will be determined in fecal samples at different taxonomic levels, and microbial diversity will be analyzed.
Measured: Basal
Enterotype classification
Metagenomic analysis in fecal samples. The bacteria DNA will be extracted and massive sequenced by the Ion Torrent platform.
Enterotypes will be analyzed to classify volunteers in 3 enterotypes based on their intestinal microbiota composition.
Measured: Basal
Creatinine levels
Quantification of creatinine concentration in basal urine and 24 hours urine samples by a colorimetric assay.
Measured: Basal and after 24 hours of juice consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start24 Feb 2020
- Primary completion22 Sep 2020
- Study completion22 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technological Centre of Nutrition and Health, Spain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rosa Solà, Dr, Principal investigator, UTNS(Eurecat_Reus)/HUSJR. Reus, Tarragona, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234100
- Sponsor's protocol ID
- FLAVOTIP
- Acronym
- FLAVOTIP
- Status last verified
- Feb 2022
- First submitted
- 13 Jan 2020
- Last updated
- 28 Feb 2022
- Results posted
- 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 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Bioavailability of Hesperidine and Narirutin Provided by an Orange Juice to Identify Various Metabotypes in Prehypertensive and Hypertensive Grade 1 Individuals (FLAVOTIP)
- ClinicalTrials.gov ID
- NCT04234100
- Acronym / sponsor ID
- FLAVOTIP / FLAVOTIP
- Conditions
- Blood Pressure, Hypertension
- Keywords
- Hypertension, Flavonoids, Orange juice, Metabotypes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Technological Centre of Nutrition and Health, SpainUniversity, hospital or other
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 22 Sep 2020 (actual)
- Study completion
- 22 Sep 2020 (actual)
- First posted
- 21 Jan 2020 (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.
Flavonoids are polyphenolic compound mainly found in fruits and vegetables with numerous beneficial health effects as protection against cardiovascular diseases by an antihypertensive effect. The intestinal microbiota plays a key role in the metabolization of these compounds, so that differences in the composition and activity of the microbiota between individuals can generate different metabotypes. Flavonoids are found mainly in their conjugated form linked to the monosaccharide rhamnose and need to be metabolized by the intestinal bacteria, releasing the rhamnose, to be absorbed and, thus, bioactive. The bacterial enzyme responsible of rhamnose hydrolysis is α-L-rhamnosidase, whose activity can vary considerably depending on the composition of the microbiota. In fact, a great interindividual variability has been observed in the ability to absorb flavonoids, which allows to classify individuals according to the corresponding metabotype. In a previous project, the investigators confirmed the interindividual differences in the bioavailability of hesperidin and narirutin, two flavonoids naturally present in orange juice. However, the role of the intestinal microbiota in the metabolism of hesperidin and narirutin needs to be elucidated.
On this basis, the following hypothesis is presented: individuals with arterial hypertension can be classified into 3 different metabotypes that are the result of the ability to absorb hesperidin and narirutin, determined by the urinary excretion of their respective metabolites, and these metabotypes are associated with different microbiota enterotypes and with different fecal α-L-rhamnosidase activity.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orange juice rich in hesperidin and narirutin | Experimental | Other: Orange juice rich in hesperidin and narirutinThe consumption of the orange juice will be made in a single dose of 500 ml. The juice is presented in a concentrated and frozen format, packed in opaque cans of 500 mL, for which it must be thawed and diluted with mineral water up to 1.5 L before its ingestion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women over 18 years of age
- Systolic blood pressure ≤159 mm Hg
- Sign the informed consent
Key exclusion criteria (17 listed)
- Body mass index (BMI) ≥ 35 kg / m2
- Glucose > 126 mg / dL
- Systolic blood pressure ≥ 160 mm Hg and diastolic blood pressure > 100 mm Hg or taking antihypertensive drugs
- LDL cholesterol > 189 mg / dL
- Triglycerides > 350 mg / dL
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 juice rich in hesperidin and narirutinThe product is a concentrated orange juice provided by the CITRUS Department of Florida (USA: www.FloridaCitrus.org). | Other | Orange juice rich in hesperidin and narirutin |
Primary outcome
Percentage of absorption of hesperidin and narirutin
Time frame: After 24 hours of juice consumption
Quantification of the metabolites derived from hesperidin and narirutin in basal and 24-hour urine samples, using Liquid Chromatography coupled to Mass Spectrometry (LC-QqQ). From the profile of metabolites detected in urine, the percentage of absorption of hesperidin and narirutin with respect to the amount ingested will be quantified to determine the metabotypes, based on the urinary excretion corresponding to each volunteer:
4 secondary outcomes
Fecal α-L-rhamnosidase activity
Time frame: Basal
Gut microbiota composition
Time frame: Basal
Enterotype classification
Time frame: Basal
Creatinine levels
Time frame: Basal and after 24 hours of juice consumption
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 28 Feb 2022.
- Technological Centre of Nutrition and Health. Eurecat\_ReusLink provided by the sponsor.
- 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.
Rosa Solà, Dr principal investigator
UTNS(Eurecat_Reus)/HUSJR. Reus, Tarragona, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orange juice rich in hesperidin and narirutin in people with Blood Pressure and Hypertension, run by Technological Centre of Nutrition and Health, Spain at 1 site 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 3 inclusion and 17 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 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Percentage of absorption of hesperidin and narirutin (time frame: After 24 hours of juice consumption). 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 28 Feb 2022.