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

T

Technological Centre of Nutrition and Health, Spain

Status

Completed

Conditions

Hypertension
Blood Pressure

Treatments

Other: Orange juice rich in hesperidin and narirutin

Study type

Interventional

Funder types

Other

Identifiers

NCT04234100
FLAVOTIP

Details and patient eligibility

About

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.

Enrollment

67 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Men and women over 18 years of age
  2. Systolic blood pressure ≤159 mm Hg
  3. Sign the informed consent

Exclusion criteria

  1. Body mass index (BMI) ≥ 35 kg / m2
  2. Glucose > 126 mg / dL
  3. Systolic blood pressure ≥ 160 mm Hg and diastolic blood pressure > 100 mm Hg or taking antihypertensive drugs
  4. LDL cholesterol > 189 mg / dL
  5. Triglycerides > 350 mg / dL
  6. Anemia (hemoglobin ≤ 13 g / dL in men and ≤ 12 g / dL in women)
  7. Tobacco addiction
  8. Consumption of medicines, antioxidants or vitamin supplements 30 days before the study
  9. Use of antibiotics during the last 30 days prior to the study
  10. Consumption of prebiotics and / or probiotics during the 30 days prior to the study
  11. Clinical history of gastrointestinal disease or presence of intestinal disorders at the time of inclusion
  12. Chronic alcoholism
  13. Monitoring a vegetarian diet
  14. Pregnant or with intent to get pregnant
  15. Being in breastfeeding period
  16. Participation in a clinical trial or nutritional intervention study, in the last 30 days.
  17. Inability to follow the study guidelines

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

67 participants in 1 patient group

Orange juice rich in hesperidin and narirutin
Experimental group
Description:
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.
Treatment:
Other: Orange juice rich in hesperidin and narirutin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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