Study of the Bioavailability of Three Hesperidin Extracts.

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

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-13

Study Completion Date

2020-03-02

Brief Summary

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

The flavonoid hesperidin is present abundantly in citrus fruits and citrus juices. The results of numerous studies suggest that hesperidin perform several beneficial effects on health, including antitumor, antioxidant, anti-inflammatory, hypocholesterolemic and hypoglycemic effects as well as decreasing blood pressure.

There are two isomers of hesperidin, -S and -R, being the predominant form in nature the isomer -S. However, currently commercialized hesperidin consists of a mixture of both isomers due to the extraction process of the hesperidin from natural sources.

The presence of the rutin disaccharide conjugated to the hesperidin molecule is responsible that most of the ingested hesperidin is metabolized by bacteria in the colon through the enzymatic activity α-rhamnosidase, being this enzymatic activity the limiting step of the hydrolysis and absorption of hesperidin. It has been suggested that the low levels of this enzymatic activity in the gut microbiota is the cause of the low bioavailability of hesperidin and also, at least in part , of the high interindividual variability that exists in the absorption of this compound.

The micronization process in order to decrease the size of the hesperidin particles is presented as a way to increase the bioavailability of hesperidin. Another way to increase the absorption of hesperidin that is proposed in this study is to increase the proportion of the isomer -S in the extracts of hesperidin, since being the isomer that mostly occurs in nature, the gut microbiota will have a greater capacity of metabolism for this isomer.

On this basis the present hypothesis is posed: the administration of hesperidin formed mainly by the isomer -S and micronized, will present greater bioavailability than hesperidin formed by a mixture of the isomers -S and -R. In turn, the bioavailability of the hesperidin formed mainly by the isomer -S and micronized will present greater bioavailability than the mixture of the isomers -S and -R and micronized.

The main objective of this study was to quantify the bioavailability of three extracts of hesperidin:

* Hesperidin extract with a mixture of the isomers -S and -R.
* Hesperidin extract with a mixture of the isomers -S and -R micronized.
* Hesperidin extract with the isomer -S micronized.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT04234100

Blood Pressure Hypertension

COMPLETED NA

Beneficial Impact of Orange Juice Consumption on Risk Factors Associated With Cardiovascular Diseases

NCT02479568

Cardiovascular Risk Factors

COMPLETED PHASE3

Effects of Hesperidin on Insulin Sensitivity

NCT01773486

Obesity Insulin Resistance

WITHDRAWN PHASE2

Vascular Effects of Hesperidin in Metabolic Syndrome

NCT00914251

Endothelial Dysfunction Metabolic Syndrome

UNKNOWN PHASE2

Orange Juice, Hesperidin and Their Role in Vascular Health Benefit

NCT04731987

Metabolic Syndrome Vascular Compliance Predisposition to Cardiovascular Disease

COMPLETED NA

Detailed Description

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

It will be conducted a post-prandial, randomized, crossover, and double-blind nutritional intervention study.

In a first phase, it will be done a pre-selection process with 30 male and female volunteers over 18 years of age. It will be determined hesperidin excreted levels in urine after the consumption of 500 mL of a homogeneous orange juice among all the participants. Sixteen participants will be selected preferably with an intermediate capacity of hesperidin absorption. The aim of this first phase is to obtain a lower variability in the results in the second phase of the study. Of the sixteen participants, six participants will start the study with the consumption of a hesperidin extract, five with the consumption of the second hesperidin extract and five with the consumption of the third hesperidin extract for, after one week washing period, exchange the hesperidin extracts between the three study groups, and finally repeat the exchange of hesperidin extracts after another week of washing period so that, in the total of the study, each participant had consumed the three hesperidin extracts.

Participants will consume two capsules with 250 mg of extract each, being the total orange extract consumed 500 mg, with 450 mg of hesperidin (90%) and the rest (10%) substances coming from the orange in the process of extracting hesperidin.

During the study there will be 5 visits, one selection (V0), one pre-inclusion (V-1) and 3 study visits (V1, V2 and V3).

Conditions

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

Biological Availability

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The appearance of the interventions is identical, appearing in capsules of identical appearance and with a numerical code.

Study Groups

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

Hesperidin Pharma

500 mg of sweet orange extract with a mixture of hesperidin isomers -S and -R. The approximate particle size is less than 100 µm for the 90% of the extract, and of 10 µm for 10% of the extract.

Group Type ACTIVE_COMPARATOR