Poor Glycemic ControlNCT02876029
Food Design for Improved Day-long Glycaemic Regulation
A study testing Reference and Test product in people with Poor Glycemic Control, run by Lund University.
Trial summary
The study focus is on the possible improvement in glucose tolerance at a second standardized meal that can be achieved when preceded by a test meal with a low GI and a high GP. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Poor Glycemic Control
- What is being tested?
- Reference and Test product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Mar 2015
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 19-25
Who cannot join
- Smoker, Diabetes, Gluten intolerance, vegetarian
About this study
Official title: The Effect on Glucose Tolerance at a Second Meal Provided After Breakfast Meal Giving Late Increment in Postprandial Glycaemia
The study focus is on the possible improvement in glucose tolerance at a second standardized meal that can be achieved when preceded by a test meal with a low GI and a high GP.
Read the detailed description
A study in healthy subjects using spaghetti as the test breakfast and a white wheat bread as the reference. Glycaemia, insulinaemia, NEFA, TG and subjective appetite are studied up to the time of the lunch meal that is served 4h after breakfast. After lunch the blood sampling continues for 2 hours.
- Conditions
- Poor Glycemic Control
- Being tested
- Reference, Test product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReferenceOther
Also called WWB
the reference product used
Test productOther
Also called Pasta
The test Product used
| Study group | Role | What they receive |
|---|---|---|
| Reference | Other | White wheat bread Receives: Other: Reference; Other: Test product |
| Test product | Other | Pasta Receives: Other: Reference; Other: Test product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose
Measured: 0-6 h
Secondary outcomes (4)
Non-esterified fatty acids (NEFA)
Measured: 0-6 h
Triglycerides (TG)
Measured: 0-6 h
Appetite rating (Visual Analogue Scale)
Measured: 0-6 h
Insulin
Measured: 0-6 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startSep 2014
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor Glycemic ControlStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elin Östman, Ass prof, Study director, Food for Health Science Centre (Medicon Village) - Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876029
- Sponsor's protocol ID
- AFC-GPSecMeal
- Status last verified
- Aug 2016
- First submitted
- 18 Aug 2016
- Last updated
- 29 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect on Glucose Tolerance at a Second Meal Provided After Breakfast Meal Giving Late Increment in Postprandial Glycaemia
- ClinicalTrials.gov ID
- NCT02876029
- Acronym / sponsor ID
- AFC-GPSecMeal
- Conditions
- Poor Glycemic Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 23 Aug 2016 (estimated)
- 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.
The study focus is on the possible improvement in glucose tolerance at a second standardized meal that can be achieved when preceded by a test meal with a low GI and a high GP.
Detailed description
A study in healthy subjects using spaghetti as the test breakfast and a white wheat bread as the reference. Glycaemia, insulinaemia, NEFA, TG and subjective appetite are studied up to the time of the lunch meal that is served 4h after breakfast. After lunch the blood sampling continues for 2 hours.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference | Other | Other: Reference, Other: Test productWhite wheat bread |
| Test product | Other | Other: Reference, Other: Test productPasta |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI 19-25
Key exclusion criteria (1 listed)
- Smoker, Diabetes, Gluten intolerance, vegetarian
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 |
|---|---|---|
| ReferenceAlso: WWBthe reference product used | Other | Reference, Test product |
| Test productAlso: PastaThe test Product used | Other | Reference, Test product |
Primary outcome
Glucose
Time frame: 0-6 h
4 secondary outcomes
Non-esterified fatty acids (NEFA)
Time frame: 0-6 h
Triglycerides (TG)
Time frame: 0-6 h
Appetite rating (Visual Analogue Scale)
Time frame: 0-6 h
Insulin
Time frame: 0-6 h
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 29 Aug 2016.
- Individual participant dataSharing planned: No
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A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Subjects With Type 2 Diabetes Mellitus and Poor Blood Glucose Control by Diet and Exercise
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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.
Elin Östman, Ass prof study director
Food for Health Science Centre (Medicon Village) - Lund University
Questions about this trial
What is this clinical trial studying?
A study testing Reference and Test product in people with Poor Glycemic Control, run by Lund University.
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 29 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Glucose (time frame: 0-6 h). 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 29 Aug 2016.