NCT03522896

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2018

Completed
Last Updated

June 28, 2018

Status Verified

June 1, 2018

Enrollment Period

9 months

First QC Date

April 30, 2018

Last Update Submit

June 27, 2018

Conditions

Effect of Food on Postprandial Hyperglycemia

Outcome Measures

Primary Outcomes (1)

  • Blood glucose concentration

    iAUC/\[glucose\]max

    3 hours

Study Arms (4)

control meal

PLACEBO COMPARATOR

glucose, fructose, sucrose, malic acid and citric acid in water

Other: control

test meal 1

EXPERIMENTAL

orange juice with added hesperidin (low dose)

Other: test meal 1

test meal 2

EXPERIMENTAL

orange juice with added hesperidin (high dose)

Other: test meal 2

test meal 3

EXPERIMENTAL

diluted orange juice with added hesperidin

Other: test meal 3

Interventions

controlOTHER

balancing sugars and organic acids

control meal
test meal 1OTHER

orange juice plus hesperidin low dose

test meal 1
test meal 2OTHER

orange juice plus hesperidin higher dose

test meal 2
test meal 3OTHER

diluted orange juice plus hesperidin low dose

test meal 3

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • fasting blood glucose below 5.9 mM

You may not qualify if:

  • fasting glucose above 6 mM pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leeds

Leeds, LS29JT, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

April 30, 2018

First Posted

May 11, 2018

Study Start

September 30, 2017

Primary Completion

June 27, 2018

Study Completion

June 27, 2018

Last Updated

June 28, 2018

Record last verified: 2018-06

Locations

GB(1)