Bioavailability of Carotenoids From Orange Juice in a Cross-over Study in Healthy Subjects.

NCT ID: NCT04744233

Last Updated: 2021-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-10-31
• Study Completion Date: 2002-11-30

Brief 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.

Detailed 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).

Conditions

Biological Availability; Carotenoids; Lutein; Humans

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Freshly squeezed orange juice (FS)

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 juice assayed was freshly squeezed (FS). Six subjects consumed FS-orange juice.

Group Type: ACTIVE_COMPARATOR

Orange juice

Intervention Type: OTHER

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.

Commercially available low pasteurized orange juice (LP)

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 was commercially available low pasteurized juice (LP). All participants consumed the LP orange juices.

Group Type: ACTIVE_COMPARATOR

Orange juice

Intervention Type: OTHER

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.

High-pressure processed orange juice(HPP)

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 was high-pressure processed (HPP). All participants consumed the HPP orange juices.

Group Type: ACTIVE_COMPARATOR

Orange juice

Intervention Type: OTHER

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.

Pulsed electric fields treated orange juice (PEF)

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 was those treated with pulsed electric fields (PEF). Six participants consumed the PEF-orange juice.

Group Type: ACTIVE_COMPARATOR

Orange juice

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 32 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Comunidad de Madrid

OTHER

Sponsor Role: collaborator

Puerta de Hierro University Hospital

OTHER

Sponsor Role: collaborator

Instituto de Ciencia y Tecnología de Alimentos y Nutrición

OTHER_GOV

Sponsor Role: lead

Responsible Party

Begoña Olmedilla

Research Scientist. Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olmedilla-Alonso

Role: PRINCIPAL_INVESTIGATOR

Instituto de Ciencia y Tecnología de Alimentos y Nutrición

Locations

Madrid, , Spain

Begoña Olmedilla-Alonso

Madrid, , Spain

Countries

Spain

Other Identifiers

CAM-HUPH-IF

Identifier Type: -

Identifier Source: org_study_id