Overview

This trial is active, not recruiting.

Condition healthy
Treatment fresh orange fruit and pasteurized fruit juice
Sponsor University of Hohenheim
Start date January 2014
End date May 2014
Trial size 12 participants
Trial identifier NCT02380144, F-2013-097

Summary

The study was designed as a randomized 2-way cross-over study to assess the bioavailability of carotenoids and flavonoids from sweet oranges and orange juice. Volunteers followed a wash-out period for 2 weeks prior to eating either 400 g of fresh oranges or 719 g of orange juice. The amount of test food was adjusted to deliver an equal amount of β-cryptoxanthin (740 µg). After a consecutive wash-out period of 2 weeks, the procedure was repeated and the volunteers ingested the complementary test food. Blood samples were collected at 8 time points up to 9.5 h after test meal consumption. Additionally, 24 h-urine was collected to evaluate flavonoid recovery.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-availability study
Intervention model crossover assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
Sequence of test foods during the intervention period: 1st: Orange fruit; 2nd: Orange juice
fresh orange fruit and pasteurized fruit juice
(Experimental)
Sequence of test foods during the intervention period: 1st: Orange juice; 2nd: Orange fruit
fresh orange fruit and pasteurized fruit juice

Primary Outcomes

Measure
Mean AUC (nmol/L*9.5 h) of beta-cryptoxanthin concentration in blood plasma chylomicrons after ingestion of fresh oranges and orange juice, respectively.
time frame: 0 - 9.5 h after each intervention

Secondary Outcomes

Measure
Mean AUC of hesperidin- and narirutin-metabolite concentration in blood plasma after ingestion of fresh oranges and orange juice, respectively.
time frame: 0 - 9.5 h after each intervention
Mean hesperetin and naringenin concentration (µmol/L) in 24 h-urine after ingestion of fresh oranges and orange juice, respectively.
time frame: 0 - 24 h after each intervention

Eligibility Criteria

Male or female participants from 23 years up to 30 years old.

Inclusion Criteria: - Healthy adult men and women - BMI: 17-60 - Age: 18-65 Exclusion Criteria: - Women who are lactating or pregnant or plan to be pregnant - Individuals using tobacco products - Individuals with metabolic or malabsorption disorders - Individuals with a history of cancer - Individuals with a history of liver insufficiency - Individuals with a history of chronic and lipid metabolism-related diseases - Individuals with an allergy to oranges - Obese individuals (BMI > 30)

Additional Information

Official title Bioavailability of Carotenoids and Flavonoids From Fresh Oranges and Orange Juice.
Principal investigator Reinhold Carle, Prof. Dr.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Hohenheim.