- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02380144
Bioavailability of Carotenoids and Flavonoids From Fresh Oranges and Orange Juice.
October 30, 2016 updated by: University of Hohenheim
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Baden-Württemberg
-
Stuttgart, Baden-Württemberg, Germany, 70599
- Chair of Plant Foodstuff Technology and Analysis (150d), University of Hohenheim
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
23 years to 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Orange Fruit - Orange Juice
Sequence of test foods during the intervention period: 1st: Orange fruit; 2nd: Orange juice |
|
Experimental: Orange Juice - Orange Fruit
Sequence of test foods during the intervention period: 1st: Orange juice; 2nd: Orange fruit |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
0 - 9.5 h after each intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
0 - 24 h after each intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Reinhold Carle, Prof. Dr., University of Hohenheim
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
May 1, 2014
Study Completion (Anticipated)
July 1, 2017
Study Registration Dates
First Submitted
February 23, 2015
First Submitted That Met QC Criteria
March 4, 2015
First Posted (Estimate)
March 5, 2015
Study Record Updates
Last Update Posted (Estimate)
November 1, 2016
Last Update Submitted That Met QC Criteria
October 30, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- F-2013-097
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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