Study of the Bioavailability of Three Hesperidin Extracts.

NCT03984916 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-02-28

No results posted yet for this study

Summary

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.

Conditions

  • Biological Availability

Interventions

DIETARY_SUPPLEMENT

Hesperidin Pharma

Two capsules with 250 mg of sweet orange extract with a mixture of hesperidin isomers -S and -R.

DIETARY_SUPPLEMENT

Hesperidin Pharma_M

Two capsules with 250 mg of sweet orange extract each with a mixture of hesperidin isomers -S and -R and micronized.

DIETARY_SUPPLEMENT

Cardiose

Two capsules with 250 mg of sweet orange extract each with more than 90% of hesperidin as isomer -S and micronized.

Sponsors & Collaborators

  • Fundació Eurecat

    collaborator OTHER
  • Hospital Universitari Sant Joan de Reus

    collaborator OTHER
  • University Rovira i Virgili

    collaborator OTHER
  • Technological Centre of Nutrition and Health, Spain

    lead OTHER

Principal Investigators

  • Rosa Solà, Dr · Centro Tecnológico de Nutrición y Salud (Eurecat_Reus). Reus, Tarragona, Spain.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-13
Primary Completion
2020-03-02
Completion
2020-03-02

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03984916 on ClinicalTrials.gov