Effect of Orange Juice on Glycemic Response

June 27, 2018 updated by: Gary Williamson, University of Leeds

Effect of Hesperidin in Orange Juice on Glycemic Response in Healthy Volunteers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Healthy volunteers will consume orange juice with added water or food-grade hesperidin.

Study Type

Interventional

Enrollment (Actual)

10

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

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • fasting blood glucose below 5.9 mM

Exclusion Criteria:

  • fasting glucose above 6 mM pregnant

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: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood glucose concentration
Time Frame: 3 hours
iAUC/[glucose]max
3 hours

Collaborators and Investigators

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

Sponsor

University of Leeds

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)

September 30, 2017

Primary Completion (Actual)

June 27, 2018

Study Completion (Actual)

June 27, 2018

Study Registration Dates

First Submitted

April 30, 2018

First Submitted That Met QC Criteria

May 10, 2018

First Posted (Actual)

May 11, 2018

Study Record Updates

Last Update Posted (Actual)

June 28, 2018

Last Update Submitted That Met QC Criteria

June 27, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEEC15-044b

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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