Back to resultsEffect of Orange Juice on Glycemic Response
Primary Purpose
Effect of Food on Postprandial Hyperglycemia
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
control
test meal 1
test meal 2
test meal 3
Sponsored by
About this trial
This is an interventional basic science trial for Effect of Food on Postprandial Hyperglycemia
Eligibility Criteria
Inclusion Criteria:
- fasting blood glucose below 5.9 mM
Exclusion Criteria:
- fasting glucose above 6 mM pregnant
Sites / Locations
- University of Leeds
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
control meal
test meal 1
test meal 2
test meal 3
Arm Description
glucose, fructose, sucrose, malic acid and citric acid in water
orange juice with added hesperidin (low dose)
orange juice with added hesperidin (high dose)
diluted orange juice with added hesperidin
Outcomes
Primary Outcome Measures
Blood glucose concentration
iAUC/[glucose]max
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03522896
Brief Title
Effect of Orange Juice on Glycemic Response
Official Title
Effect of Hesperidin in Orange Juice on Glycemic Response in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
September 30, 2017 (Actual)
Primary Completion Date
June 27, 2018 (Actual)
Study Completion Date
June 27, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leeds
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Healthy volunteers will consume orange juice with added water or food-grade hesperidin.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effect of Food on Postprandial Hyperglycemia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control meal
Arm Type
Placebo Comparator
Arm Description
glucose, fructose, sucrose, malic acid and citric acid in water
Arm Title
test meal 1
Arm Type
Experimental
Arm Description
orange juice with added hesperidin (low dose)
Arm Title
test meal 2
Arm Type
Experimental
Arm Description
orange juice with added hesperidin (high dose)
Arm Title
test meal 3
Arm Type
Experimental
Arm Description
diluted orange juice with added hesperidin
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
balancing sugars and organic acids
Intervention Type
Other
Intervention Name(s)
test meal 1
Intervention Description
orange juice plus hesperidin low dose
Intervention Type
Other
Intervention Name(s)
test meal 2
Intervention Description
orange juice plus hesperidin higher dose
Intervention Type
Other
Intervention Name(s)
test meal 3
Intervention Description
diluted orange juice plus hesperidin low dose
Primary Outcome Measure Information:
Title
Blood glucose concentration
Description
iAUC/[glucose]max
Time Frame
3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
fasting blood glucose below 5.9 mM
Exclusion Criteria:
fasting glucose above 6 mM pregnant
Facility Information:
Facility Name
University of Leeds
City
Leeds
ZIP/Postal Code
LS29JT
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Orange Juice on Glycemic Response
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