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Completed

NCT Number: NCT04744233

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

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.

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Key information

Age range

20 year–32 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Begoña Olmedilla-Alonso, Madrid, Spain

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Orange juice

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.

Primary outcomes

  1. Assessment of the effect of dairy intake of orange juice elaborated with four different procedures on the serum carotenoid concentrations of healthy adults.

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Instituto de Ciencia y Tecnología de Alimentos y Nutrición

Other Gov

Collaborators

  • Comunidad de Madrid
  • Instituto de Salud Carlos III
  • Puerta de Hierro University Hospital

Registry information

Official study title

Effect of Traditional and Emerging Conservation Technologies on Bioactive Compounds and Their Antioxidant Capacity in Plant Foods

Important dates

Study start
2001
Primary completion
2002
Study completion
2002
First posted
Feb 8, 2021
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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