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

NCT04234100 | Completed

• 1 other identifier: FLAVOTIP
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Hypertension; Flavonoids; Orange juice; Metabotypes

Outcome Measures

Primary Outcomes (1)

• 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:

  After 24 hours of juice consumption

Secondary Outcomes (4)

• Fecal α-L-rhamnosidase activity

  Basal

• Gut microbiota composition

  Basal

• Enterotype classification

  Basal

• Creatinine levels

  Basal and after 24 hours of juice consumption

Study Arms (1)

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.

Other: Orange juice rich in hesperidin and narirutin

Interventions

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).

Orange juice rich in hesperidin and narirutin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women over 18 years of age
• Systolic blood pressure ≤159 mm Hg
• Sign the informed consent

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Technological Centre of Nutrition and Health, Spain: lead

Study Sites (1)

Centro Tecnológico de Nutrición y Salud (Eurecat-Reus)

Reus, Tarragona, Spain

Location

Related Links

• Technological Centre of Nutrition and Health. Eurecat\_Reus

MeSH Terms

Conditions

Hypertension

Interventions

Hesperidin; narirutin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Flavanones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glycosides; Carbohydrates

Study Officials

• Rosa Solà, Dr

  UTNS(Eurecat_Reus)/HUSJR. Reus, Tarragona, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: January 21, 2020
• Study Start: February 24, 2020
• Primary Completion: September 22, 2020
• Study Completion: September 22, 2020
• Last Updated: February 28, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)