Effect of Food on Postprandial HyperglycemiaNCT03522896
Effect of Orange Juice on Glycemic Response
A study testing test meal 1, test meal 2 and test meal 3 in people with Effect of Food on Postprandial Hyperglycemia, run by University of Leeds at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Effect of Food on Postprandial Hyperglycemia
- What is being tested?
- test meal 1, test meal 2 and test meal 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Sep 2017to 27 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- fasting blood glucose below 5.9 mM
Who cannot join
- fasting glucose above 6 mM pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
Healthy volunteers will consume orange juice with added water or food-grade hesperidin.
- Being tested
- control, test meal 1, test meal 2, test meal 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
controlOther
balancing sugars and organic acids
test meal 1Other
orange juice plus hesperidin low dose
test meal 2Other
orange juice plus hesperidin higher dose
test meal 3Other
diluted orange juice plus hesperidin low dose
| Study group | Role | What they receive |
|---|---|---|
| control meal | Placebo comparator | glucose, fructose, sucrose, malic acid and citric acid in water Receives: Other: control |
| test meal 1 | Experimental | orange juice with added hesperidin (low dose) Receives: Other: test meal 1 |
| test meal 2 | Experimental | orange juice with added hesperidin (high dose) Receives: Other: test meal 2 |
| test meal 3 | Experimental | diluted orange juice with added hesperidin Receives: Other: test meal 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose concentration
iAUC/[glucose]max
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start30 Sep 2017
- Primary completion27 Jun 2018
- Study completion27 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Food on Postprandial HyperglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary Williamson, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522896
- Sponsor's protocol ID
- MEEC15-044b
- Status last verified
- Jun 2018
- First submitted
- 30 Apr 2018
- Last updated
- 28 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hesperidin in Orange Juice on Glycemic Response in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03522896
- Acronym / sponsor ID
- MEEC15-044b
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- 30 Sep 2017 (actual)
- Primary completion
- 27 Jun 2018 (actual)
- Study completion
- 27 Jun 2018 (actual)
- First posted
- 11 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control meal | Placebo comparator | Other: controlglucose, fructose, sucrose, malic acid and citric acid in water |
| test meal 1 | Experimental | Other: test meal 1orange juice with added hesperidin (low dose) |
| test meal 2 | Experimental | Other: test meal 2orange juice with added hesperidin (high dose) |
| test meal 3 | Experimental | Other: test meal 3diluted orange juice with added hesperidin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- fasting blood glucose below 5.9 mM
Key exclusion criteria (1 listed)
- fasting glucose above 6 mM pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| controlbalancing sugars and organic acids | Other | control meal |
| test meal 1orange juice plus hesperidin low dose | Other | test meal 1 |
| test meal 2orange juice plus hesperidin higher dose | Other | test meal 2 |
| test meal 3diluted orange juice plus hesperidin low dose | Other | test meal 3 |
Primary outcome
Blood glucose concentration
Time frame: 3 hours
iAUC/[glucose]max
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
- Individual participant dataSharing planned: Undecided
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Personalized Nutrition Based on the Glycemic Response: Effect of Diet and Intestinal Microbiota
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing test meal 1, test meal 2 and test meal 3 in people with Effect of Food on Postprandial Hyperglycemia, run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose concentration (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2018.