NCT03358745

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 2, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 9, 2019

Status Verified

May 1, 2019

Enrollment Period

1.8 years

First QC Date

November 27, 2017

Last Update Submit

May 8, 2019

Conditions

Metabolic Syndrome XInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Keywords

Type 2 diabetes riskCardiovascular disease risk

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Area under the curve (AUC) of postprandial triglyceridemia

    4 hours postprandial

  • Area under the curve (AUC) of postprandial insulinemia

    4 hours postprandial

  • Area under the curve (AUC) of postprandial Glucagon-like peptide (GLP-1), Peptide YY (PYY) and glucose-dependent insulinotropic polypeptide (GIP)

    4 hours

Study Arms (4)

Standard meal, bread/butter as starter

EXPERIMENTAL

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

Standard meal with soup as starter

EXPERIMENTAL

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

Standard meal with cheese as starter

EXPERIMENTAL

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

Standard meal with salad as starter

EXPERIMENTAL

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

Interventions

Standard meal, bread/butter as starterOTHER

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, bread/butter as starter
Standard meal with soup as starterOTHER

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 soup as starter
Standard meal with cheese as starterOTHER

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 cheese as starter
Standard meal with salad as starterOTHER

Lunch meal in which salad is eaten during the first 15 min. Bread, butter, soup and cheese are eaten within the following 15 min.

Standard meal with salad as starter

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI between 20 and 30 kg/m2
  • Fasting blood glucose ≤ 6.1 mmol/L
  • No known medical condition

You may not qualify if:

  • Smoking habits
  • Treatment for high blood pressure
  • Treatment for hypercholesterolemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Antidiabetic Food Centre, Chemical Centre. Lund University

Lund, Skåne County, 221 00, Sweden

Location

Food for Health Science Centre. Lund University Medicon Village

Lund, SE 223 81, Sweden

Location

Related Publications (4)

  • 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.

    PMID: 25724569BACKGROUND

  • 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.

    PMID: 19360495BACKGROUND

  • 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.

    PMID: 21828339BACKGROUND

  • 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.

    PMID: 22721722BACKGROUND

MeSH Terms

Conditions

Metabolic SyndromeInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Interventions

BreadButterCheeseSalads

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesDietary FatsFatsLipidsDairy ProductsCultured Milk ProductsMilkBeveragesFermented Foods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Leader

Study Record Dates

First Submitted

November 27, 2017

First Posted

December 2, 2017

Study Start

June 1, 2016

Primary Completion

March 31, 2018

Study Completion

December 1, 2018

Last Updated

May 9, 2019

Record last verified: 2019-05

Locations

SE(2)