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Impact of Meal Order on Postprandial Cardiometabolic Risk Markers

Primary Purpose

Metabolic Syndrome X, Insulin Resistance, Hyperinsulinism

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Standard meal, bread/butter as starter
Standard meal with soup as starter
Standard meal with cheese as starter
Standard meal with salad as starter
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome X focused on measuring Type 2 diabetes risk, Cardiovascular disease risk

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Antidiabetic Food Centre, Chemical Centre. Lund University
  • Food for Health Science Centre. Lund University Medicon Village

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Standard meal, bread/butter as starter

Standard meal with soup as starter

Standard meal with cheese as starter

Standard meal with salad as starter

Arm Description

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.

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).

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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

Full Information

First Posted
November 27, 2017
Last Updated
May 8, 2019
Sponsor
Lund University
Collaborators
Vinnova, Anti-Diabetic Food Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03358745
Brief Title
Impact of Meal Order on Postprandial Cardiometabolic Risk Markers
Official Title
Impact of Meal Order on Postprandial Cardiometabolic Risk Markers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
March 31, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lund University
Collaborators
Vinnova, Anti-Diabetic Food Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome X, Insulin Resistance, Hyperinsulinism, Glucose Metabolism Disorders, Metabolic Diseases
Keywords
Type 2 diabetes risk, Cardiovascular disease risk

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard meal, bread/butter as starter
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard meal with soup as starter
Arm Type
Experimental
Arm Description
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).
Arm Title
Standard meal with cheese as starter
Arm Type
Experimental
Arm Description
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).
Arm Title
Standard meal with salad as starter
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Standard meal, bread/butter as starter
Intervention Description
Reference lunch. Bread and butter are eaten during the first 15 min. Soup, cheese and salad are eaten within the following 15 min.
Intervention Type
Other
Intervention Name(s)
Standard meal with soup as starter
Intervention Description
Lunch meal in which soup is eaten during the first 15 min. Bread, butter, cheese and salad are eaten within the following 15 min.
Intervention Type
Other
Intervention Name(s)
Standard meal with cheese as starter
Intervention Description
Lunch meal in which cheese is eaten during the first 15 min. Bread, butter, soup and salad are eaten within the following 15 min.
Intervention Type
Other
Intervention Name(s)
Standard meal with salad as starter
Intervention Description
Lunch meal in which salad is eaten during the first 15 min. Bread, butter, soup and cheese are eaten within the following 15 min.
Primary Outcome Measure Information:
Title
Area under the curve of postprandial glycemia
Description
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.
Time Frame
4 hours postprandial
Secondary Outcome Measure Information:
Title
Area under the curve (AUC) of postprandial triglyceridemia
Description
Area under the curve (AUC) of postprandial triglyceridemia (0-4h) after each intervention, compared to the reference meal
Time Frame
4 hours postprandial
Title
Area under the curve (AUC) of postprandial insulinemia
Description
Area under the curve (AUC) of postprandial insulinemia (0-4h) after each intervention, compared to the reference meal
Time Frame
4 hours postprandial
Title
Area under the curve (AUC) of postprandial Glucagon-like peptide (GLP-1), Peptide YY (PYY) and glucose-dependent insulinotropic polypeptide (GIP)
Description
Area under the curve (AUC) of postprandial GLP-1, GIP and PYY (0-4h) after each intervention, compared to the reference meal
Time Frame
4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Antidiabetic Food Centre, Chemical Centre. Lund University
City
Lund
State/Province
Skane
ZIP/Postal Code
221 00
Country
Sweden
Facility Name
Food for Health Science Centre. Lund University Medicon Village
City
Lund
ZIP/Postal Code
SE 223 81
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
25724569
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.
Results Reference
background
PubMed Identifier
19360495
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.
Results Reference
background
PubMed Identifier
21828339
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.
Results Reference
background
PubMed Identifier
22721722
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.
Results Reference
background

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Impact of Meal Order on Postprandial Cardiometabolic Risk Markers

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