Clinical trial NCT04234100: Bioavailability of Hesperidine and Narirutin From Orange Juice to Identify Metabotypes in Hypertension
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Hypertension
Keywords: Hypertension
Flavonoids
Orange juice
Metabotypes
Lead sponsor: Technological Centre of Nutrition and Health, Spain
Sponsor class: OTHER
First posted: 2020-01-21
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of absorption of hesperidin and narirutin
timeFrame: After 24 hours of juice consumption
Secondary outcomes:
measure: Fecal α-L-rhamnosidase activity
timeFrame: Basal
measure: Gut microbiota composition
timeFrame: Basal
measure: Enterotype classification
timeFrame: Basal
measure: Creatinine levels
timeFrame: Basal and after 24 hours of juice consumption
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Centro Tecnológico de Nutrición y Salud (Eurecat-Reus)
state: Tarragona
Study officials:
affiliation: UTNS(Eurecat_Reus)/HUSJR. Reus, Tarragona, Spain
name: Rosa Solà, Dr
role: PRINCIPAL_INVESTIGATOR
References: