Impact of Meal Order on Postprandial Cardiometabolic Risk Markers

Insulin Resistance Clinical Trial

Official title:

Impact of Meal Order on Postprandial Cardiometabolic Risk Markers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03358745
• Other study ID #: AFC2016-17.JT
• Status: Completed
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: December 1, 2018

Study information

• Verified date: May 2019
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 1, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Metabolism Disorders
• Hyperinsulinism
• Insulin Resistance
• Metabolic Diseases
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Sweden	Antidiabetic Food Centre, Chemical Centre. Lund University	Lund	Skane
Sweden	Food for Health Science Centre. Lund University Medicon Village	Lund

Sponsors (3)

Lead Sponsor	Collaborator
Lund University	Anti-Diabetic Food Centre, Vinnova

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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