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Completed

NCT Number: NCT04234100

Bioavailability of Hesperidine and Narirutin From Orange Juice to Identify Metabotypes in Hypertension

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.

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Key information

Conditions

Blood Pressure Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Tecnológico de Nutrición y Salud (Eurecat-Reus)

Reus, Tarragona, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orange juice rich in hesperidin and narirutin

Other

The product is a concentrated orange juice provided by the CITRUS Department of Florida (USA: www.FloridaCitrus.org).

Primary outcomes

  1. 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:

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Creatinine levels

    Time frame: Basal and after 24 hours of juice consumption

    Quantification of creatinine concentration in basal urine and 24 hours urine samples by a colorimetric assay.

Sponsors and collaborators

Lead sponsor

Technological Centre of Nutrition and Health, Spain

Other

Registry information

Official study 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)

Acronym: FLAVOTIP

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 21, 2020
Registry last updated
Feb 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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