Impact of Meal Order on Postprandial Cardiometabolic Risk Markers

Sponsor

Lund University (Other)

Overall Status

Completed

CT.gov ID

NCT03358745

Collaborator

Vinnova (Other), Anti-Diabetic Food Centre (Other)

Enrollment

Locations

Arms

Actual Duration (Months)

10.5

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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	N/A

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

Study Type:

Interventional

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 :

Jun 1, 2016

Actual Primary Completion Date :

Mar 31, 2018

Actual Study Completion Date :

Dec 1, 2018

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 [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 [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 Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Antidiabetic Food Centre, Chemical Centre. Lund University	Lund	Skane	Sweden	221 00
2	Food for Health Science Centre. Lund University Medicon Village	Lund		Sweden	SE 223 81