Metabolic Syndrome XNCT03358745
Impact of Meal Order on Postprandial Cardiometabolic Risk Markers
A study testing Standard meal, bread/butter as starter, Standard meal with soup as starter and Standard meal with cheese as starter in people with Metabolic Syndrome X and Insulin Resistance, run by Lund University at 2 sites in Sweden.
Trial summary
The order in which the different components of a meal are eaten may have impact on the postprandial metabolic responses to carbohydrates, fat and proteins. This study will compare blood lipids and glycemia regulation following lunches of identical composition but varying the order of intake of the different meal… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome X, Insulin Resistance, Hyperinsulinism
- What is being tested?
- Standard meal, bread/butter as starter, Standard meal with soup as starter and Standard meal with cheese as starter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Jun 2016to 1 Dec 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI between 20 and 30 kg/m2
- Fasting blood glucose ≤ 6.1 mmol/L
- No known medical condition
Who cannot join
- Smoking habits
- Treatment for high blood pressure
- Treatment for hypercholesterolemia
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Antidiabetic Food Centre, Chemical Centre. Lund University
Lund, Skåne County, 221 00
Food for Health Science Centre. Lund University Medicon Village
Lund, SE 223 81
About this study
The order in which the different components of a meal are eaten may have impact on the postprandial metabolic responses to carbohydrates, fat and proteins. This study will compare blood lipids and glycemia regulation following lunches of identical composition but varying the order of intake of the different meal components.
Read the detailed description
The order in which the different components of a meal are eaten may have impact on the postprandial metabolic responses to carbohydrates, fat and proteins. Some of these responses are associated with the risk for developing cardiometabolic complications.
The study will be carried out in a cohort of healthy subjects with a wide BMI range and normal fasting glycemia. Postprandial metabolic responses to a reference meal starting with bread and butter (BB) will be compared with those registered after 3 other meals of identical composition, in which the starter will be permutated. Each meal is tested on an independent experimental session, with a 1 week washout interval.
The intervention will be carried out at the Food for Health Science Centre - Lund University. Additionally, the plan contemplates an initial information visit including screening of fasting blood glucose. In total, each volunteer completing the study will pay five visits to the clinical unit.
Based on the results from the above-described phase, a second step of the study will compare various quality attributes of the most effective starter on the impact on cardiometabolic risk markers, as a way to optimize putative protective actions and to gain further mechanistic insight.
- Conditions
- Metabolic Syndrome X, Insulin Resistance, Hyperinsulinism, Glucose Metabolism Disorders, Metabolic Diseases
- Being tested
- Standard meal, bread/butter as starter, Standard meal with soup as starter, Standard meal with cheese as starter, Standard meal with salad as starter
- Keywords
- Type 2 diabetes risk, Cardiovascular disease risk
- Medical subject headings
- Metabolic Syndrome, Insulin Resistance, Hyperinsulinism, Glucose Metabolism Disorders, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard meal, bread/butter as starterOther
Reference lunch. Bread and butter are eaten during the first 15 min. Soup, cheese and salad are eaten within the following 15 min.
Standard meal with soup as starterOther
Lunch meal in which soup is eaten during the first 15 min. Bread, butter, cheese and salad are eaten within the following 15 min.
Standard meal with cheese as starterOther
Lunch meal in which cheese is eaten during the first 15 min. Bread, butter, soup and salad are eaten within the following 15 min.
Standard meal with salad as starterOther
Lunch meal in which salad is eaten during the first 15 min. Bread, butter, soup and cheese are eaten within the following 15 min.
| Study group | Role | What they receive |
|---|---|---|
| Standard meal, bread/butter as starter | Experimental | Subjects eat a reference lunch (reference lunch) at 11:30 am, 4 h after a defined light breakfast. The meal contains 38 g fat and 885 kcal and consists of bread and butter, soup, salad and cheese. The participants eat the bread and butter portion within 15 min and the remaining components of the meal are consumed within the following 15 min (total eating time=30 min).
Blood samples are taken before the lunch and every 30 min postprandial for 4 h. Receives: Other: Standard meal, bread/butter as starter |
| Standard meal with soup as starter | Experimental | Subjects eat a reference lunch (reference lunch) at 11:30 am, 4 h after a defined light breakfast. The meal contains 38 g fat and 885 kcal. The participants eat the soup portion within 15 min and the remaining components of the meal are consumed within the following 15 min (total eating time=30 min). Receives: Other: Standard meal with soup as starter |
| Standard meal with cheese as starter | Experimental | Subjects eat a reference lunch (reference lunch) at 11:30 am, 4 h after a defined light breakfast. The meal contains 38 g fat and 885 kcal. The participants eat the cheese portion within 15 min and the remaining components of the meal are consumed within the following 15 min (total eating time=30 min). Receives: Other: Standard meal with cheese as starter |
| Standard meal with salad as starter | Experimental | Subjects eat a reference lunch (reference lunch) at 11:30 am, 4 h after a defined light breakfast. The meal contains 38 g fat and 885 kcal. The participants eat the salad portion within 15 min and the remaining components of the meal are consumed within the following 15 min (total eating time=30 min). Receives: Other: Standard meal with salad as starter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve of postprandial glycemia
Area under the curve of postprandial glycemia (0-4h) after each intervention, compared to the reference meal.
Plasma glucose is measured pre-meal and and at various post-meal intervals for up to for 4 hours. AUC is calculated and compared to AUC recorded after the reference meal.
Measured: 4 hours postprandial
Secondary outcomes (3)
Area under the curve (AUC) of postprandial triglyceridemia
Area under the curve (AUC) of postprandial triglyceridemia (0-4h) after each intervention, compared to the reference meal
Measured: 4 hours postprandial
Area under the curve (AUC) of postprandial insulinemia
Area under the curve (AUC) of postprandial insulinemia (0-4h) after each intervention, compared to the reference meal
Measured: 4 hours postprandial
Area under the curve (AUC) of postprandial Glucagon-like peptide (GLP-1), Peptide YY (PYY) and glucose-dependent insulinotropic polypeptide (GIP)
Area under the curve (AUC) of postprandial GLP-1, GIP and PYY (0-4h) after each intervention, compared to the reference meal
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start1 Jun 2016
- Primary completion31 Mar 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Metabolic Syndrome XStudies 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
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Vinnova, Anti-Diabetic Food Centre
- Responsible party
- Principal investigator, Juscelino Tovar, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358745
- Sponsor's protocol ID
- AFC2016-17.JT
- Status last verified
- May 2019
- First submitted
- 27 Nov 2017
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jakubowicz D, Wainstein J, Ahren B, Bar-Dayan Y, Landau Z, Rabinovitz HR, Froy O. High-energy breakfast with low-energy dinner decreases overall daily hyperglycaemia in type 2 diabetic patients: a randomised clinical trial. Diabetologia. 2015 May;58(5):912-9. doi: 10.1007/s00125-015-3524-9. Epub 2015 Mar 1.
PubMed 25724569Esquirol Y, Bongard V, Mabile L, Jonnier B, Soulat JM, Perret B. Shift work and metabolic syndrome: respective impacts of job strain, physical activity, and dietary rhythms. Chronobiol Int. 2009 Apr;26(3):544-59. doi: 10.1080/07420520902821176.
PubMed 19360495Lee SH, Tura A, Mari A, Ko SH, Kwon HS, Song KH, Yoon KH, Lee KW, Ahn YB. Potentiation of the early-phase insulin response by a prior meal contributes to the second-meal phenomenon in type 2 diabetes. Am J Physiol Endocrinol Metab. 2011 Nov;301(5):E984-90. doi: 10.1152/ajpendo.00244.2011. Epub 2011 Aug 9.
PubMed 21828339Dejeans N, Herosimczyk A, Sayd T, Chambon C, Martin JF, Maier JA, Tauveron I, Mazur A. Effect of a high-fat challenge on the proteome of human postprandial plasma. Clin Nutr. 2013 Jun;32(3):468-71. doi: 10.1016/j.clnu.2012.05.017. Epub 2012 Jun 19.
PubMed 22721722
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Meal Order on Postprandial Cardiometabolic Risk Markers
- ClinicalTrials.gov ID
- NCT03358745
- Acronym / sponsor ID
- AFC2016-17.JT
- Conditions
- Metabolic Syndrome X, Insulin Resistance, Hyperinsulinism, Glucose Metabolism Disorders, Metabolic Diseases
- Keywords
- Type 2 diabetes risk, Cardiovascular disease risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Vinnova, Anti-Diabetic Food Centre
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 2 Dec 2017 (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.
The order in which the different components of a meal are eaten may have impact on the postprandial metabolic responses to carbohydrates, fat and proteins. This study will compare blood lipids and glycemia regulation following lunches of identical composition but varying the order of intake of the different meal components.
Detailed description
The order in which the different components of a meal are eaten may have impact on the postprandial metabolic responses to carbohydrates, fat and proteins. Some of these responses are associated with the risk for developing cardiometabolic complications.
The study will be carried out in a cohort of healthy subjects with a wide BMI range and normal fasting glycemia. Postprandial metabolic responses to a reference meal starting with bread and butter (BB) will be compared with those registered after 3 other meals of identical composition, in which the starter will be permutated. Each meal is tested on an independent experimental session, with a 1 week washout interval.
The intervention will be carried out at the Food for Health Science Centre - Lund University. Additionally, the plan contemplates an initial information visit including screening of fasting blood glucose. In total, each volunteer completing the study will pay five visits to the clinical unit.
Based on the results from the above-described phase, a second step of the study will compare various quality attributes of the most effective starter on the impact on cardiometabolic risk markers, as a way to optimize putative protective actions and to gain further mechanistic insight.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard meal, bread/butter as starter | Experimental | Other: Standard meal, bread/butter as starterSubjects eat a reference lunch (reference lunch) at 11:30 am, 4 h after a defined light breakfast. The meal contains 38 g fat and 885 kcal and consists of bread and butter, soup, salad and cheese. The participants eat the bread and butter portion within 15 min and the remaining components of the meal are consumed within the following 15 min (total eating time=30 min). Blood samples are taken before the lunch and every 30 min postprandial for 4 h. |
| Standard meal with soup as starter | Experimental | Other: Standard meal with soup as starterSubjects eat a reference lunch (reference lunch) at 11:30 am, 4 h after a defined light breakfast. The meal contains 38 g fat and 885 kcal. The participants eat the soup portion within 15 min and the remaining components of the meal are consumed within the following 15 min (total eating time=30 min). |
| Standard meal with cheese as starter | Experimental | Other: Standard meal with cheese as starterSubjects eat a reference lunch (reference lunch) at 11:30 am, 4 h after a defined light breakfast. The meal contains 38 g fat and 885 kcal. The participants eat the cheese portion within 15 min and the remaining components of the meal are consumed within the following 15 min (total eating time=30 min). |
| Standard meal with salad as starter | Experimental | Other: Standard meal with salad as starterSubjects eat a reference lunch (reference lunch) at 11:30 am, 4 h after a defined light breakfast. The meal contains 38 g fat and 885 kcal. The participants eat the salad portion within 15 min and the remaining components of the meal are consumed within the following 15 min (total eating time=30 min). |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI between 20 and 30 kg/m2
- Fasting blood glucose ≤ 6.1 mmol/L
- No known medical condition
Key exclusion criteria (3 listed)
- Smoking habits
- Treatment for high blood pressure
- Treatment for hypercholesterolemia
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 |
|---|---|---|
| Standard meal, bread/butter as starterReference lunch. Bread and butter are eaten during the first 15 min. Soup, cheese and salad are eaten within the following 15 min. | Other | Standard meal, bread/butter as starter |
| Standard meal with soup as starterLunch meal in which soup is eaten during the first 15 min. Bread, butter, cheese and salad are eaten within the following 15 min. | Other | Standard meal with soup as starter |
| Standard meal with cheese as starterLunch meal in which cheese is eaten during the first 15 min. Bread, butter, soup and salad are eaten within the following 15 min. | Other | Standard meal with cheese as starter |
| Standard meal with salad as starterLunch meal in which salad is eaten during the first 15 min. Bread, butter, soup and cheese are eaten within the following 15 min. | Other | Standard meal with salad as starter |
Primary outcome
Area under the curve of postprandial glycemia
Time frame: 4 hours postprandial
Area under the curve of postprandial glycemia (0-4h) after each intervention, compared to the reference meal. Plasma glucose is measured pre-meal and and at various post-meal intervals for up to for 4 hours. AUC is calculated and compared to AUC recorded after the reference meal.
3 secondary outcomes
Area under the curve (AUC) of postprandial triglyceridemia
Time frame: 4 hours postprandial
Area under the curve (AUC) of postprandial insulinemia
Time frame: 4 hours postprandial
Area under the curve (AUC) of postprandial Glucagon-like peptide (GLP-1), Peptide YY (PYY) and glucose-dependent insulinotropic polypeptide (GIP)
Time frame: 4 hours
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 9 May 2019.
- Background: PubMed 25724569Jakubowicz D, Wainstein J, Ahren B, Bar-Dayan Y, Landau Z, Rabinovitz HR, Froy O. High-energy breakfast with low-energy dinner decreases overall daily hyperglycaemia in type 2 diabetic patients: a randomised clinical trial. Diabetologia. 2015 May;58(5):912-9. doi: 10.1007/s00125-015-3524-9. Epub 2015 Mar 1.
- Background: PubMed 19360495Esquirol Y, Bongard V, Mabile L, Jonnier B, Soulat JM, Perret B. Shift work and metabolic syndrome: respective impacts of job strain, physical activity, and dietary rhythms. Chronobiol Int. 2009 Apr;26(3):544-59. doi: 10.1080/07420520902821176.
- Background: PubMed 21828339Lee SH, Tura A, Mari A, Ko SH, Kwon HS, Song KH, Yoon KH, Lee KW, Ahn YB. Potentiation of the early-phase insulin response by a prior meal contributes to the second-meal phenomenon in type 2 diabetes. Am J Physiol Endocrinol Metab. 2011 Nov;301(5):E984-90. doi: 10.1152/ajpendo.00244.2011. Epub 2011 Aug 9.
- Background: PubMed 22721722Dejeans N, Herosimczyk A, Sayd T, Chambon C, Martin JF, Maier JA, Tauveron I, Mazur A. Effect of a high-fat challenge on the proteome of human postprandial plasma. Clin Nutr. 2013 Jun;32(3):468-71. doi: 10.1016/j.clnu.2012.05.017. Epub 2012 Jun 19.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard meal, bread/butter as starter, Standard meal with soup as starter and Standard meal with cheese as starter in people with Metabolic Syndrome X and Insulin Resistance, run by Lund University at 2 sites 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 3 inclusion and 3 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 9 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 of postprandial glycemia (time frame: 4 hours postprandial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03358745, which also lists 4 linked publications.
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 9 May 2019.