- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04234100
Bioavailability of Hesperidine and Narirutin From Orange Juice to Identify Metabotypes in Hypertension (FLAVOTIP)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Tarragona
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Reus, Tarragona, Spain
- Centro Tecnológico de Nutrición y Salud (Eurecat-Reus)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Men and women over 18 years of age
- Systolic blood pressure ≤159 mm Hg
- Sign the informed consent
Exclusion Criteria:
- 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)
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Orange juice rich in hesperidin and narirutin
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.
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The product is a concentrated orange juice provided by the CITRUS Department of Florida (USA: www.FloridaCitrus.org).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of absorption of hesperidin and narirutin
Time Frame: After 24 hours of juice consumption
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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: |
After 24 hours of juice consumption
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fecal α-L-rhamnosidase activity
Time Frame: Basal
|
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.
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Basal
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Gut microbiota composition
Time Frame: Basal
|
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. |
Basal
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Enterotype classification
Time Frame: Basal
|
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. |
Basal
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Creatinine levels
Time Frame: Basal and after 24 hours of juice consumption
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Quantification of creatinine concentration in basal urine and 24 hours urine samples by a colorimetric assay.
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Basal and after 24 hours of juice consumption
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Collaborators and Investigators
Investigators
- Principal Investigator: Rosa Solà, Dr, UTNS(Eurecat_Reus)/HUSJR. Reus, Tarragona, Spain
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FLAVOTIP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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