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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04744233
Other study ID # CAM-HUPH-IF
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2001
Est. completion date November 2002

Study information

Verified date February 2021
Source Instituto de Ciencia y Tecnología de Alimentos y Nutrición
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Commercially available fruit juices are obtained after applying industrial technologies to preserve and extend the shelf-life by inactivation of microorganism and enzymes. These are traditional thermal treatment (eg. pasteurization, sterilization) that causes losses of nutritional and bioactive compounds, changes physicochemical properties (colour, flavor and texture) and can modify their bioavailabilities. Thus, the traditional thermal processing is being replaced by less intense thermal technologies (e.g. low-temperature pasteurization / refrigerated storage) and non-thermal treatments such as the high-pressure processing (HPP) and the pulsed electric fields (PEF) as an alternative to enhace food safety and shelf-life without compromising organoleptic qualities (retain the flavour, color healthiness of fresh foods) and keeping their health-promoting capacity. The beneficial health effect derived from the orange juice intake is partly related to the bioavailability of their bioactive compounds. The aim of this study was to assess the effect of the intake of freshly squeezed orange juice (Citrus sinensis L.) and processed orange juice elaborated with different treatments (low pasteurization / refrigerated storage, high-pressure processing, pulsed electric fields) on the main serum carotenoid concentrations in a cross-over study in apparently healthy subjects using multiple dosis.


Description:

Methods Twelve healthy subjects (6 men), age 20-32 y, were enrolled in a cross-over study, to consume 500 mL of orange juice/day during 14 days periods. All volunteers consumed the LP and HPP, six consumed PEF or FS-orange juice. Fasted blood was collected at baseline and on days 7 and 14. Carotenoid concentrations in serum and orange juice were analyzed by high performance liquid chromatogry (HPLC).


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date November 2002
Est. primary completion date June 2002
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 32 Years
Eligibility Inclusion Criteria: - age (20- 32 y) - body mass index (BMI) - serum cholesterol and triglycerides concentrations within the normal range - serum retinol within the range 31 - 70 µg/dL. Exclusion Criteria: - vitamin / mineral supplements intake - regular medication - pregnancy or lactating - chronic disease - smoking habit.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Orange juice
Subjects were enrolled to consume 500 mL of orange juice/day during three consecutive 14 days periods separated by 1 - 1.5 month washouts. The orange juices assayed were: freshly squeezed (FS), commercially available low pasteurized juice (LP) and juices treated by high-pressure processing (HPP) and by pulsed electric fields (PEF). All participants consumed the LP and the HPP orange juices. Six subjects consumed PEF-orange juice and other six consumed the FS-orange juice.

Locations

Country Name City State
Spain Begoña Olmedilla-Alonso Madrid

Sponsors (4)

Lead Sponsor Collaborator
Instituto de Ciencia y Tecnología de Alimentos y Nutrición Comunidad de Madrid, Instituto de Salud Carlos III, Puerta de Hierro University Hospital

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of the effect of dairy intake of orange juice elaborated with four different procedures on the serum carotenoid concentrations of healthy adults. Assessment of the effect of dairy intake of orange juice elaborated with low temperature pasterurization (LP), high-pressure processing (HPP), pulsed electric fields (PEF) and freshly squeezd (FS) on the serum carotenoid concentrations of healthy adults. 6 months
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