Bioavailability of Carotenoids and Flavonoids From Fresh Oranges and Orange Juice.
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Jan 2014
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 23, 2015
CompletedFirst Posted
Study publicly available on registry
March 5, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedNovember 1, 2016
October 1, 2016
4 months
February 23, 2015
October 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean AUC (nmol/L*9.5 h) of beta-cryptoxanthin concentration in blood plasma chylomicrons after ingestion of fresh oranges and orange juice, respectively.
0 - 9.5 h after each intervention
Secondary Outcomes (2)
Mean AUC of hesperidin- and narirutin-metabolite concentration in blood plasma after ingestion of fresh oranges and orange juice, respectively.
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.
0 - 24 h after each intervention
Study Arms (2)
Orange Fruit - Orange Juice
EXPERIMENTALSequence of test foods during the intervention period: 1st: Orange fruit; 2nd: Orange juice
Orange Juice - Orange Fruit
EXPERIMENTALSequence of test foods during the intervention period: 1st: Orange juice; 2nd: Orange fruit
Interventions
Eligibility Criteria
You may qualify if:
- Healthy adult men and women
- BMI: 17-60
- Age: 18-65
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chair of Plant Foodstuff Technology and Analysis (150d), University of Hohenheim
Stuttgart, Baden-Wurttemberg, 70599, Germany
Related Publications (1)
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.
PMID: 26114420RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Reinhold Carle, Prof. Dr.
University of Hohenheim
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2015
First Posted
March 5, 2015
Study Start
January 1, 2014
Primary Completion
May 1, 2014
Study Completion
July 1, 2017
Last Updated
November 1, 2016
Record last verified: 2016-10