Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Orange Juice on Glycemic Response

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03522896
Recruitment Status : Completed
First Posted : May 11, 2018
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Gary Williamson, University of Leeds

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Orange juice naturally contains high concentrations of hesperidin, which affects glucose absorption in in vitro experiments. This study is to test if hesperidin and other components of orange juice (not other sugars or organic acids) affect the post-prandial blood glucose concentration derived from sugars already present in the orange juice.

Condition or disease Intervention/treatment Phase
Effect of Food on Postprandial Hyperglycemia Other: control Other: test meal 1 Other: test meal 2 Other: test meal 3 Not Applicable

Detailed Description:
Healthy volunteers will consume orange juice with added water or food-grade hesperidin.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Effect of Hesperidin in Orange Juice on Glycemic Response in Healthy Volunteers
Actual Study Start Date : September 30, 2017
Actual Primary Completion Date : June 27, 2018
Actual Study Completion Date : June 27, 2018
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Placebo Comparator: control meal
glucose, fructose, sucrose, malic acid and citric acid in water
 Other: control
balancing sugars and organic acids
Experimental: test meal 1
orange juice with added hesperidin (low dose)
 Other: test meal 1
orange juice plus hesperidin low dose
Experimental: test meal 2
orange juice with added hesperidin (high dose)
 Other: test meal 2
orange juice plus hesperidin higher dose
Experimental: test meal 3
diluted orange juice with added hesperidin
 Other: test meal 3
diluted orange juice plus hesperidin low dose


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Blood glucose concentration [ Time Frame: 3 hours ]
    iAUC/[glucose]max


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • fasting blood glucose below 5.9 mM

Exclusion Criteria:

  • fasting glucose above 6 mM pregnant
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522896


Locations
Layout table for location information
United Kingdom
University of Leeds
Leeds, United Kingdom, LS29JT
Sponsors and Collaborators
University of Leeds
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Gary Williamson, Prof, University of Leeds
ClinicalTrials.gov Identifier: NCT03522896    
Other Study ID Numbers: MEEC15-044b
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases