Bioavailability of Carotenoids and Flavonoids From Fresh Oranges and Orange Juice.

Healthy Clinical Trial

Official title:

Bioavailability of Carotenoids and Flavonoids From Fresh Oranges and Orange Juice.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02380144
• Other study ID #: F-2013-097
• Status: Active, not recruiting
• Phase: N/A
• First received: February 23, 2015
• Last updated: October 30, 2016
• Start date: January 2014
• Est. completion date: July 2017

Study information

• Verified date: October 2016
• Source: University of Hohenheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: July 2017
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 23 Years to 30 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Fresh orange fruit and pasteurized fruit juice

Locations

Country	Name	City	State
Germany	Chair of Plant Foodstuff Technology and Analysis (150d), University of Hohenheim	Stuttgart	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University of Hohenheim

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Aschoff JK, Rolke CL, Breusing N, Bosy-Westphal A, Högel J, Carle R, Schweiggert RM. Bioavailability of ß-cryptoxanthin is greater from pasteurized orange juice than from fresh oranges - a randomized cross-over study. Mol Nutr Food Res. 2015 Oct;59(10):18 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No