HealthyNCT02380144
Bioavailability of Carotenoids and Flavonoids From Fresh Oranges and Orange Juice.
A study testing Fresh orange fruit and pasteurized fruit juice in people with Healthy, run by University of Hohenheim at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 23 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fresh orange fruit and pasteurized fruit juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2014to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult men and women
- BMI: 17-60
- Age: 18-65
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Chair of Plant Foodstuff Technology and Analysis (150d), University of Hohenheim
Stuttgart, Baden-Wurttemberg, 70599
About this study
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.
- Conditions
- Healthy
- Being tested
- Fresh orange fruit and pasteurized fruit juice
- Keywords
- carotenoid, bioavailability, beta-cryptoxanthin, flavonoid, hesperidin, narirutin, randomized cross-over, Pharmacokinetics, micronutrients, Oranges/Orange Juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh orange fruit and pasteurized fruit juiceOther
| Study group | Role | What they receive |
|---|---|---|
| Orange Fruit - Orange Juice | Experimental | Sequence of test foods during the intervention period:
1st: Orange fruit; 2nd: Orange juice Receives: Other: Fresh orange fruit and pasteurized fruit juice |
| Orange Juice - Orange Fruit | Experimental | Sequence of test foods during the intervention period:
1st: Orange juice; 2nd: Orange fruit Receives: Other: Fresh orange fruit and pasteurized fruit juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean AUC (nmol/L*9.5 h) of beta-cryptoxanthin concentration in blood plasma chylomicrons after ingestion of fresh oranges and orange juice, respectively.
Measured: 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.
Measured: 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.
Measured: 0 - 24 h after each intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startJan 2014
- Primary completionMay 2014
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hohenheim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reinhold Carle, Prof. Dr., Principal investigator, University of Hohenheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380144
- Sponsor's protocol ID
- F-2013-097
- Status last verified
- Oct 2016
- First submitted
- 23 Feb 2015
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26114420
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Carotenoids and Flavonoids From Fresh Oranges and Orange Juice.
- ClinicalTrials.gov ID
- NCT02380144
- Acronym / sponsor ID
- F-2013-097
- Conditions
- Healthy
- Keywords
- carotenoid, bioavailability, beta-cryptoxanthin, flavonoid, hesperidin, narirutin, randomized cross-over, Pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of HohenheimUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- May 2014 (actual)
- Study completion
- Jul 2017 (estimated)
- First posted
- 5 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orange Fruit - Orange Juice | Experimental | Other: Fresh orange fruit and pasteurized fruit juiceSequence of test foods during the intervention period: 1st: Orange fruit; 2nd: Orange juice |
| Orange Juice - Orange Fruit | Experimental | Other: Fresh orange fruit and pasteurized fruit juiceSequence of test foods during the intervention period: 1st: Orange juice; 2nd: Orange fruit |
Who may qualify
- Ages
- 23 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adult men and women
- BMI: 17-60
- Age: 18-65
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fresh orange fruit and pasteurized fruit juice | Other | Orange Fruit - Orange Juice, Orange Juice - Orange Fruit |
Primary outcome
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
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
- Results publication: PubMed 26114420Aschoff 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reinhold Carle, Prof. Dr. principal investigator
University of Hohenheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fresh orange fruit and pasteurized fruit juice in people with Healthy, run by University of Hohenheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02380144, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2016.