Impact of Meal Order on Postprandial Cardiometabolic Risk Markers

Not Applicable

Completed

• Conditions: Metabolic Syndrome X; Hyperinsulinism; Metabolic Diseases; Insulin Resistance; Glucose Metabolism Disorders
• Interventions: Other: Standard meal, bread/butter as starter; Other: Standard meal with cheese as starter; Other: Standard meal with salad as starter; Other: Standard meal with soup as starter

• Registration Number: NCT03358745
• Lead Sponsor: Lund University

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.

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 Timeline

• Study Start: 2016-06-01
• Study First Submitted: 2017-11-27
• Study First Submitted QC: 2017-11-30
• Study First Posted: 2017-12-02
• Primary Completion: 2018-03-31
• Study Completion: 2018-12-01
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-08
• Last Update Posted: 2019-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard meal, bread/butter as starter	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 cheese as starter	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	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 with soup as starter	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).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

Food for Health Science Centre. Lund University Medicon Village; 🇸🇪 Lund, Sweden

Antidiabetic Food Centre, Chemical Centre. Lund University; 🇸🇪 Lund, Skane, Sweden