Impact of Meal Order on Postprandial Cardiometabolic Risk Markers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Meal Order on Postprandial Cardiometabolic Risk Markers

Conditions
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Metabolic Syndrome X, Insulin Resistance, Hyperinsulinism, Glucose Metabolism Disorders, Metabolic Diseases

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard meal, bread/butter as starter<br>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<br>* Reference lunch. Bread and butter are eaten during the first 15 min. Soup, cheese and salad are eaten within the following 15 min.<br>|
| Experimental: Standard meal with soup as starter<br>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<br>* Lunch meal in which soup is eaten during the first 15 min. Bread, butter, cheese and salad are eaten within the following 15 min.<br>|
| Experimental: Standard meal with cheese as starter<br>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<br>* Lunch meal in which cheese is eaten during the first 15 min. Bread, butter, soup and salad are eaten within the following 15 min.<br>|
| Experimental: Standard meal with salad as starter<br>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<br>* Lunch meal in which salad is eaten during the first 15 min. Bread, butter, soup and cheese are eaten within the following 15 min.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 hours postprandial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes risk, Cardiovascular disease risk