Impact of Meal Order on Postprandial Cardiometabolic Risk Markers

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ClinicalTrials.gov Identifier: NCT03358745

Recruitment Status : Completed

First Posted : December 2, 2017

Last Update Posted : May 9, 2019

Sponsor:

Collaborators:

Vinnova

Anti-Diabetic Food Centre

Information provided by (Responsible Party):

Juscelino Tovar, Lund University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Metabolic Syndrome X Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases	Other: Standard meal, bread/butter as starter Other: Standard meal with soup as starter Other: Standard meal with cheese as starter Other: Standard meal with salad as starter	Not Applicable

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

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	21 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Impact of Meal Order on Postprandial Cardiometabolic Risk Markers
Actual Study Start Date :	June 1, 2016
Actual Primary Completion Date :	March 31, 2018
Actual Study Completion Date :	December 1, 2018

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Abdominal Obesity Metabolic Syndrome

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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 Reference lunch. Bread and butter are eaten during the first 15 min. Soup, cheese and salad are eaten within the following 15 min.
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 Lunch meal in which soup is eaten during the first 15 min. Bread, butter, cheese and salad are eaten within the following 15 min.
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 Lunch meal in which cheese is eaten during the first 15 min. Bread, butter, soup and salad are eaten within the following 15 min.
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 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 Outcome Measures :

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.

Secondary Outcome Measures :

Area under the curve (AUC) of postprandial triglyceridemia [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 Criteria

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Ages Eligible for Study:	20 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03358745

Locations

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

Sponsors and Collaborators

Lund University

Vinnova

Anti-Diabetic Food Centre

More Information

Publications:

Jakubowicz D, Wainstein J, Ahrén 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.

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.

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.

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.

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Responsible Party:	Juscelino Tovar, Project Leader, Lund University
ClinicalTrials.gov Identifier:	NCT03358745 History of Changes
Other Study ID Numbers:	AFC2016-17.JT
First Posted:	December 2, 2017 Key Record Dates
Last Update Posted:	May 9, 2019
Last Verified:	May 2019

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Juscelino Tovar, Lund University:


Type 2 diabetes risk Cardiovascular disease risk

Additional relevant MeSH terms:

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Metabolic Syndrome Insulin Resistance Metabolic Diseases Glucose Metabolism Disorders Hyperinsulinism

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