Clinical trial NCT03358745: Impact of Meal Order on Postprandial Cardiometabolic Risk Markers
Official title: Impact of Meal Order on Postprandial Cardiometabolic Risk Markers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Keywords: Type 2 diabetes risk
Cardiovascular disease risk
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Vinnova
name: Anti-Diabetic Food Centre
First posted: 2017-12-02
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Area under the curve of postprandial glycemia
timeFrame: 4 hours postprandial
Secondary outcomes:
measure: Area under the curve (AUC) of postprandial triglyceridemia
timeFrame: 4 hours postprandial
measure: Area under the curve (AUC) of postprandial insulinemia
timeFrame: 4 hours postprandial
measure: Area under the curve (AUC) of postprandial Glucagon-like peptide (GLP-1), Peptide YY (PYY) and glucose-dependent insulinotropic polypeptide (GIP)
timeFrame: 4 hours
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Antidiabetic Food Centre, Chemical Centre. Lund University
state: Skane
city: Lund
country: Sweden
facility: Food for Health Science Centre. Lund University Medicon Village
Study officials:
References:
citation: Jakubowicz D, Wainstein J, Ahren 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.
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.
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.
citation: 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.