NCT02380144

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 5, 2015

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

4 months

First QC Date

February 23, 2015

Last Update Submit

October 30, 2016

Conditions

Keywords

carotenoidbioavailabilitybeta-cryptoxanthinflavonoidhesperidinnarirutinrandomized cross-overPharmacokineticsmicronutrientsOranges/Orange Juice

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

EXPERIMENTAL

Sequence of test foods during the intervention period: 1st: Orange fruit; 2nd: Orange juice

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

Other: Fresh orange fruit and pasteurized fruit juice

Interventions

Orange Fruit - Orange JuiceOrange Juice - Orange Fruit

Eligibility Criteria

Age23 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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.

Study Officials

  • Reinhold Carle, Prof. Dr.

    University of Hohenheim

    PRINCIPAL INVESTIGATOR

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

Locations