Clinical trial NCT02380144: Bioavailability of Carotenoids and Flavonoids From Fresh Oranges and Orange Juice.
Official title: Bioavailability of Carotenoids and Flavonoids From Fresh Oranges and Orange Juice.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: carotenoid
bioavailability
beta-cryptoxanthin
flavonoid
hesperidin
narirutin
randomized cross-over
Pharmacokinetics
micronutrients
Oranges/Orange Juice
Lead sponsor: University of Hohenheim
Sponsor class: OTHER
First posted: 2015-03-05
Enrollment: 12
Sex: ALL
Minimum age (years): 23
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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)

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.
timeFrame: 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.
timeFrame: 0 - 9.5 h after each intervention
measure: Mean hesperetin and naringenin concentration (µmol/L) in 24 h-urine after ingestion of fresh oranges and orange juice, respectively.
timeFrame: 0 - 24 h after each intervention
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Chair of Plant Foodstuff Technology and Analysis (150d), University of Hohenheim
state: Baden-Württemberg
Study officials:
affiliation: University of Hohenheim
name: Reinhold Carle, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aschoff JK, Rolke CL, Breusing N, Bosy-Westphal A, Hogel J, Carle R, Schweiggert RM. Bioavailability of beta-cryptoxanthin is greater from pasteurized orange juice than from fresh oranges - a randomized cross-over study. Mol Nutr Food Res. 2015 Oct;59(10):1896-904. doi: 10.1002/mnfr.201500327. Epub 2015 Jul 20.