Healthy Volunteers Recruited From the General PopulationNCT01779622
Rapid Versus Slow Ingestion of Mixed Meal: Influence on Islet and Incretin Hormone Secretion in Healthy Volunteers
A study testing Mixed meal in people with Healthy Volunteers Recruited From the General Population, run by Lund University at 1 site in Sweden.
Trial summary
To test the influence of rapid versus slow ingestion of a mixed meal on insulin and incretin hormone secretion in healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers Recruited From the General Population
- What is being tested?
- Mixed meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2013to Jun 2014
- 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
- Healthy subjects
Who cannot join
- Diabetes Liver disease Kidney disease Thyroid disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rapid Versus Slow Ingestion of Mixed Meal: Influence on Islet and Incretin
To test the influence of rapid versus slow ingestion of a mixed meal on insulin and incretin hormone secretion in healthy volunteers
Read the detailed description
A mixed meal (524 kcal) is ingested rapidly (within 5 min) or slowly (10-15 min) and changes in insulin, glucagon, GIP and GLP-1 levels are followed for subsequent 300 min
- Being tested
- Mixed meal
- Keywords
- mixed meal¨, insulin, glucagon, GIP, GLP-1
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed mealOther
Ingestion of mixed meal
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Healthy volunteers are ingesting a mixed meal either rapidly or slowly Receives: Other: Mixed meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve for insulin
Measured: 300 min
Secondary outcomes (2)
Area under the curve for glucose-dependent insuinotropic polypeptide
Measured: 300 min
Area under the curve for glucagon-like peptide-1
Measured: 300 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startJun 2013
- Primary completionJan 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers Recruited From the General PopulationStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Ahren, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779622
- Sponsor's protocol ID
- 17
- Other IDs
- 2013-000449-38
- Status last verified
- Sep 2014
- First submitted
- 27 Jan 2013
- Last updated
- 30 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Versus Slow Ingestion of Mixed Meal: Influence on Islet and Incretin
- ClinicalTrials.gov ID
- NCT01779622
- Acronym / sponsor ID
- 17
- Keywords
- mixed meal¨, insulin, glucagon, GIP, GLP-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 30 Jan 2013 (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.
To test the influence of rapid versus slow ingestion of a mixed meal on insulin and incretin hormone secretion in healthy volunteers
Detailed description
A mixed meal (524 kcal) is ingested rapidly (within 5 min) or slowly (10-15 min) and changes in insulin, glucagon, GIP and GLP-1 levels are followed for subsequent 300 min
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Mixed mealHealthy volunteers are ingesting a mixed meal either rapidly or slowly |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy subjects
Key exclusion criteria (1 listed)
- Diabetes Liver disease Kidney disease Thyroid disease
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 |
|---|---|---|
| Mixed mealIngestion of mixed meal | Other | 1 |
Primary outcome
Area under the curve for insulin
Time frame: 300 min
2 secondary outcomes
Area under the curve for glucose-dependent insuinotropic polypeptide
Time frame: 300 min
Area under the curve for glucagon-like peptide-1
Time frame: 300 min
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 30 Sep 2014.
- Faculty of Medicine, Lund universityLink provided by the sponsor.
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 Mixed meal in people with Healthy Volunteers Recruited From the General Population, run by Lund University at 1 site in Sweden.
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 30 Sep 2014. 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 Sweden. 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. 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?
Area under the curve for insulin (time frame: 300 min). 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 30 Sep 2014.