Impact of Meal Order on Postprandial Cardiometabolic Risk Markers

NCT03358745 — Not applicable, Completed, 21 participants, Lund University

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Registry	NCT03358745
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: none, prevention
Enrollment	21 (Actual)
Sponsor	Lund University (Other); collaborators: Vinnova, Anti-Diabetic Food Centre
Conditions	Metabolic Syndrome X, Insulin Resistance, Hyperinsulinism, Glucose Metabolism Disorders, Metabolic Diseases
Interventions	Standard meal, bread/butter as starter, Standard meal with soup as starter, Standard meal with cheese as starter, Standard meal with salad as starter (Other)
Dates	start 2016-06-01, primary completion 2018-03-31, completion 2018-12-01, first posted 2017-12-02, last updated 2019-05-09
Locations	2 sites in Sweden

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Standard meal, bread/butter as starter	Experimental	Other: 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.
Standard meal with soup as starter	Experimental	Other: 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).
Standard meal with cheese as starter	Experimental	Other: 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).
Standard meal with salad as starter	Experimental	Other: 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).

Standard meal, bread/butter as starter (Other): 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 starter (Other): 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 starter (Other): 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 starter (Other): Lunch meal in which salad is eaten during the first 15 min. Bread, butter, soup and cheese are eaten within the following 15 min.

+Outcome measures

Primary outcomes

Area under the curve of postprandial glycemia [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.

Secondary outcomes

Area under the curve (AUC) of postprandial triglyceridemia [4 hours postprandial]: Area under the curve (AUC) of postprandial triglyceridemia (0-4h) after each intervention, compared to the reference meal
Area under the curve (AUC) of postprandial insulinemia [4 hours postprandial]: Area under the curve (AUC) of postprandial insulinemia (0-4h) after each intervention, compared to the reference meal
Area under the curve (AUC) of postprandial Glucagon-like peptide (GLP-1), Peptide YY (PYY) and glucose-dependent insulinotropic polypeptide (GIP) [4 hours]: Area under the curve (AUC) of postprandial GLP-1, GIP and PYY (0-4h) after each intervention, compared to the reference meal

+Eligibility

Sex: All, ages: 20 Years to 70 Years, accepts healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

* Smoking habits
* Treatment for high blood pressure
* Treatment for hypercholesterolemia

+Locations (2)

Facility	City	Country	Status
Antidiabetic Food Centre, Chemical Centre. Lund University	Lund, Skåne County	Sweden
Food for Health Science Centre. Lund University Medicon Village	Lund	Sweden

+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. PMID 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. PMID 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. PMID 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. PMID 22721722