Biological Availability Clinical Trial
— HESPERIDINOfficial title:
Interventional Study for the Comparison of the Bioavailability of Three Hesperidin Extracts (HESPERIDIN).
NCT number | NCT03984916 |
Other study ID # | HESPERIDIN |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 13, 2019 |
Est. completion date | March 2, 2020 |
Verified date | February 2022 |
Source | Technological Centre of Nutrition and Health, Spain |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | March 2, 2020 |
Est. primary completion date | March 2, 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. Firm the informed consent. Exclusion Criteria: 1. Take supplements or multivitamin supplements or phytotherapeutic products that interfere with the treatment under study up to 30 days before the start of the study. 2. Present intolerances and / or food allergies related to hesperidin. 3. Take antibiotics up to 30 days before the start of the study. 4. Being pregnant or intending to become pregnant. 5. Be in breastfeeding period. 6. Be a smoker 7. Participate in or have participate in a clinical trial or nutritional intervention study in the last 30 days prior to inclusion in the study. 8. Be vegetarian. 9. Present some chronic gastrointestinal disease. 10. Present some chronic disease in clinical manifestation. |
Country | Name | City | State |
---|---|---|---|
Spain | Centro Tecnológico de Nutrición y Salud (Eurecat-Reus) | Reus | Tarragona |
Lead Sponsor | Collaborator |
---|---|
Technological Centre of Nutrition and Health, Spain | Fundació Eurecat, Hospital Universitari Sant Joan de Reus, University Rovira i Virgili |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bioavailability of hesperidin calculated by urine hesperidin concentration | Fasting hesperidin metabolites levels in urine will be determined before consuming the capsule with orange extract and in four fractions of time (0-3 hours; 3-6 hours; 6-9 hors and 9-24 hours) until 24 hours postprandially after consuming the capsule.
The hesperidin levels in urine will be quantified with a Liquid Chromatography (LC)- Mass Spectrometry (MS) equipment. |
At week 2, week 3 and week 4. | |
Secondary | Area Under The Curve (AUC) of plasma hesperidin levels. | Fasting hesperidin metabolites levels in blood will be determined before consuming the capsule with orange extract until 24 hours postprandially at 8 points after consuming the capsule (2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours and 24 hours).
The hesperidin levels in urine will be quantified with a Liquid Chromatography (LC)- Mass Spectrometry (MS) equipment. |
At week 2, week 3 and week 4. | |
Secondary | Maximum plasma concentration (Cmax). | Maximum plasma concentration of hesperidin. | At week 2, week 3 and week 4. | |
Secondary | Time for maximum plasma concentration (Tmax). | Time period for the maximum plasma concentration of hesperidin. | At week 2, week 3 and week 4. | |
Secondary | Half-life (T1/2). | Time taken for half the initial dose of hesperidin administered to be eliminated from the body | At week 2, week 3 and week 4. | |
Secondary | Hesperidin catabolites levels in plasma. | Fasting hesperidin catabolites levels in blood will be determined before consuming the capsule with orange extract until 24 hours postprandially at 8 points after consuming the capsule (2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours and 24 hours).
The hesperidin levels in urine will be quantified with a Liquid Chromatography (LC)- Mass Spectrometry (MS) equipment. |
At week 2, week 3 and week 4. | |
Secondary | Hesperidin catabolites in urine. | Fasting hesperidin catabolites levels in urine will be determined before consuming the capsule with orange extract and in four fractions of time (0-3 hours; 3-6 hours; 6-9 hors and 9-24 hours) until 24 hours postprandially after consuming the capsule.
The hesperidin levels in urine will be quantified with a Liquid Chromatography (LC)- Mass Spectrometry (MS) equipment. |
At week 2, week 3 and week 4. | |
Secondary | Quantification of hesperidin bioavailability for the selection of individuals | For the selection of intermediate hesperidin absorption individuals fasting hesperidin metabolites levels in urine will be determined before consuming 500 ml of an orange juice and in 24 hours postprandially after consuming the orange juice.
The hesperidin levels in urine will be quantified with a Liquid Chromatography (LC)- Mass Spectrometry (MS) equipment. |
At week 1. |
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