Clinical trial NCT04744233: Bioavailability of Carotenoids From Orange Juice in a Cross-over Study in Healthy Subjects.
Official title: Effect of Traditional and Emerging Conservation Technologies on Bioactive Compounds and Their Antioxidant Capacity in Plant Foods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biological Availability
Carotenoids
Lutein
Humans
Lead sponsor: Instituto de Ciencia y Tecnología de Alimentos y Nutrición
Sponsor class: OTHER_GOV
Collaborators: name: Comunidad de Madrid
name: Instituto de Salud Carlos III
name: Puerta de Hierro University Hospital
First posted: 2021-02-08
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 32
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Multiple dose cross-over study.
Primary purpose: BASIC_SCIENCE

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).

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.

Primary outcomes:
measure: Assessment of the effect of dairy intake of orange juice elaborated with four different procedures on the serum carotenoid concentrations of healthy adults.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
city: Madrid
country: Spain
facility: Begoña Olmedilla-Alonso
Study officials:
affiliation: Instituto de Ciencia y Tecnología de Alimentos y Nutrición
name: Olmedilla-Alonso
role: PRINCIPAL_INVESTIGATOR
References: