Orange Juice Consumption and Glucose Metabolism and Antioxidative Status

April 22, 2017 updated by: University of Hohenheim

Impact of Orange Juice Consumption on Glucose Homeostasis and Antioxidative Status in Healthy Subjects

Aim of the study is to investigate the impact of orange juice consumption (with meals or between meals) as well as sugar sweetened beverage (SSB) consumption (between meals) on glucose homeostasis and antioxidative status.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Duration of the study is 3x three weeks including one wash-out week each followed by two weeks of juice/SSB consumption under free living conditions.

During wash-out weeks consumption of orange juice or citrus fruits is restricted.

During intervention weeks, participants are asked to eat three regular meals per day without snacking. Intervention weeks are (i) orange juice consumption with meals (ii) orange juice consumption between meals and (iii) SSB consumption between meals. Daily energy intake with orange juice/SSB is 20% of individual energy requirement. Additional caloric beverages (SSB, juice, coffee with sugar/milk, alcohol) are not allowed. At the beginning and the end of each intervention phase insulin sensitivity and antioxidative status are assessed.

Study Type

Interventional

Enrollment (Actual)

26

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
      • Stuttgart, Germany, 70599
        • Institute of Nutritional Medicine, 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

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy

Exclusion Criteria:

  • regular use of medication,
  • smoking,
  • chronic disease,
  • vegan/vegetarian diet,
  • fructose intolerance,
  • irregular eating behaviour (less then 3 meals/day)

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: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Orange juice with meals
Effect of orange juice consumption with three meals per day (without snacking) on glucose metabolism and antioxidative status
Dietary supplement: Orange juice with meals
orange juice (20% of energy requirement/day)
Experimental: Orange juice between meals
Effect of orange juice consumption between three meals per day (without snacking) on glucose metabolism and antioxidative status
Dietary supplement: Orange juice between meals
orange juice (20% of energy requirement/day)
Experimental: Sugar sweetened beverage between meals
Effect of sugar sweetened beverage consumption between three meals per day (without snacking) on glucose metabolism and antioxidative status
Dietary supplement: Sugar sweetened beverage between meals
Sugar sweetened beverage (20% of energy requirement/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in daylong glycaemia between pre and post intervention periods
Time Frame: two weeks
measured via continuous glucose monitoring [mg/dL]
two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in uric acid between pre and post intervention periods
Time Frame: two weeks
measured via uric acid serum levels [mg/dL]
two weeks
changes in insulin sensitivity between pre and post intervention periods
Time Frame: two weeks
measured via "Matsuda-Index" from oral glucose tolerance test data
two weeks
changes in antioxidative status between pre and post intervention periods
Time Frame: two weeks
measured via vitamin c blood levels [mg/L]
two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Hohenheim

Investigators

  • Principal Investigator: Anja Bosy-Westphal, Prof PhD, University of Hohenheim, Stuttgart, Germany

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 (Actual)

April 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

November 2, 2016

First Submitted That Met QC Criteria

November 22, 2016

First Posted (Estimate)

November 28, 2016

Study Record Updates

Last Update Posted (Actual)

April 25, 2017

Last Update Submitted That Met QC Criteria

April 22, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OrangeJuice

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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