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

NCT ID: NCT04234100

Last Updated: 2022-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-24

Study Completion Date

2020-09-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Blood Pressure Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Orange juice rich in hesperidin and narirutin

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.

Group Type EXPERIMENTAL

Orange juice rich in hesperidin and narirutin

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Technological Centre of Nutrition and Health, Spain

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rosa Solà, Dr

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centro Tecnológico de Nutrición y Salud (Eurecat-Reus)

Reus, Tarragona, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Related Links

Access external resources that provide additional context or updates about the study.

http://eurecat.org

Technological Centre of Nutrition and Health. Eurecat\_Reus

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FLAVOTIP

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Impact of Watermelon Juice on Blood Pressure
NCT04328311 ACTIVE_NOT_RECRUITING NA
Impact of Oranges on Cardiovascular Health
NCT01935362 COMPLETED PHASE1/PHASE2