ClinicalTrials.gg
CompletedNCT03358745Updated May 9, 2019

Impact of Meal Order on Postprandial Cardiometabolic Risk Markers

An interventional study of Standard meal, bread/butter as starter and Standard meal with soup as starter in Metabolic Syndrome X, Insulin Resistance and Hyperinsulinism, sponsored by Lund University. Completed at 2 sites in Sweden. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-09.

Sponsored by Lund University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Jun 2016, registered Nov 2017).

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Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 14 studies in Metabolic Syndrome by Lund University — none open to participants now, none under way, none of them phase 3. Metabolic Syndrome · Lund University.

Enrollment
5th of 14
21 · median 21
Started
2016
with 1 other
No phase
8 of 14
none open now
Registered
14th of 14
by date

Among the 14 studies in Metabolic Syndrome by Lund University, this one is the 5th largest by enrollment, is one of 2 that started in 2016, is one of 8 with no phase, and was the 14th registered.

Metabolic Syndrome

2,117 studies on the registry are indexed under Metabolic Syndrome; 347 are open to participants now.

Browse Metabolic Syndrome studies →

Open to participants now

None of the 14 studies in Metabolic Syndrome by Lund University is open now. The open studies under Metabolic Syndrome, anywhere →

Where they have run

Who these studies take

Of the 231 Metabolic Syndrome studies recruiting now, 68 (29%) set no upper age limit and 135 (58%) stop at 75 or younger; 20 take children under 18; 80 take healthy volunteers.

This study: 20 Years to 70 Years · all sexes · healthy volunteers too.

The full table on the hub →

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Download CSVNarrow it in search →With an account: the 14 studies in Metabolic Syndrome by Lund University as a file.
02

Study 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 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.

03

Conditions studied

  • Metabolic Syndrome X
  • Insulin Resistance
  • Hyperinsulinism
  • Glucose Metabolism Disorders
  • Metabolic Diseases

Keywords

  • Type 2 diabetes risk
  • Cardiovascular disease risk
04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • between 20 and 30 kg/m2
  • Fasting blood glucose ≤ 6.1 mmol/L
  • No known medical condition

Exclusion criteria

Exclusion Criteria:

  • Smoking habits
  • Treatment for high blood pressure
  • Treatment for hypercholesterolemia
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    Standard meal, bread/butter as starter

    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.

    Other: Standard meal, bread/butter as starter

  • Experimental
    Standard meal with soup as starter

    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).

    Other: Standard meal with soup as starter

  • Experimental
    Standard meal with cheese as starter

    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).

    Other: Standard meal with cheese as starter

  • Experimental
    Standard meal with salad as starter

    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).

    Other: Standard meal with salad as starter

Interventions

  • OtherStandard meal, bread/butter as starter

    Reference lunch. Bread and butter are eaten during the first 15 min. Soup, cheese and salad are eaten within the following 15 min.

  • OtherStandard meal with soup as starter

    Lunch meal in which soup is eaten during the first 15 min. Bread, butter, cheese and salad are eaten within the following 15 min.

  • OtherStandard meal with cheese as starter

    Lunch meal in which cheese is eaten during the first 15 min. Bread, butter, soup and salad are eaten within the following 15 min.

  • OtherStandard meal with salad as starter

    Lunch meal in which salad is eaten during the first 15 min. Bread, butter, soup and cheese are eaten within the following 15 min.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 hours postprandial

Secondary outcomes

  1. 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

    Time frame: 4 hours postprandial

  2. 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

    Time frame: 4 hours postprandial

  3. 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

    Time frame: 4 hours

07

Study locations

2 sites
  • Antidiabetic Food Centre, Chemical Centre. Lund University
    Lund, Skane 221 00, Sweden
  • Food for Health Science Centre. Lund University Medicon Village
    Lund, SE 223 81, Sweden
08

References and documents

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 25724569 ↗
  • Esquirol 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 19360495 ↗
  • Lee 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 21828339 ↗
  • Dejeans 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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2016 to primary completion in Mar 2018, 21 months.

Of 625 non-industry interventional studies with no phase under Metabolic Syndrome, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 41. This study's 21 months is close to that.

Counting every sponsor, half of 675 studies reached it within 20 months; a quarter within 9 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 27, 2017
First posted
Dec 2, 2017
StartActual
Jun 1, 2016
Primary completionActual
Mar 31, 2018
CompletionActual
Dec 1, 2018
Last update
May 9, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03358745
Lead sponsor
Lund University
Collaborators
Vinnova, Anti-Diabetic Food Centre
Responsible party
Juscelino Tovar (Project Leader, Lund University) — Principal investigator
First posted
Dec 2, 2017
Start date
Jun 1, 2016
Primary completion
Mar 31, 2018
Completion
Dec 1, 2018
Last update
May 9, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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