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

Hypertension Clinical Trial

— FLAVOTIP  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04234100
• Other study ID #: FLAVOTIP
• Status: Completed
• Phase: N/A
• Start date: February 24, 2020
• Est. completion date: September 22, 2020

Study information

• Verified date: February 2022
• Source: Technological Centre of Nutrition and Health, Spain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: September 22, 2020
• Est. primary completion date: September 22, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Hypertension

Intervention

Other:
• Orange juice rich in hesperidin and narirutin
The product is a concentrated orange juice provided by the CITRUS Department of Florida (USA: www.FloridaCitrus.org).

Locations

Country	Name	City	State
Spain	Centro Tecnológico de Nutrición y Salud (Eurecat-Reus)	Reus	Tarragona

Sponsors (1)

Lead Sponsor	Collaborator
Technological Centre of Nutrition and Health, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fecal a-L-rhamnosidase activity	Quantification of a-L-rhamnosidase activity in fecal samples by incubation of the samples with the substrate p-nitrophenyl a-Lrhamnopyranoside and the subsequent measurement of the aborsbance to a length wavelength of 405 nM in a spectrophotometer.	Basal
Secondary	Gut microbiota composition	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
Secondary	Enterotype classification	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
Secondary	Creatinine levels	Quantification of creatinine concentration in basal urine and 24 hours urine samples by a colorimetric assay.	Basal and after 24 hours of juice consumption

External Links

•   Technological Centre of Nutrition and Health. Eurecat_Reus