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

  • Germany
    • 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
Other: Fresh orange fruit and pasteurized fruit juice
Experimental: Orange Juice - Orange Fruit

Sequence of test foods during the intervention period:

1st: Orange juice; 2nd: Orange fruit
Other: Fresh orange fruit and pasteurized fruit juice

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

University of Hohenheim

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.

General Publications

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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