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Impact of Meal Order on Postprandial Cardiometabolic Risk Markers

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ClinicalTrials.gov Identifier: NCT03358745
Recruitment Status : Completed
First Posted : December 2, 2017
Last Update Posted : May 9, 2019
Sponsor:
Collaborators:
Vinnova
Anti-Diabetic Food Centre
Information provided by (Responsible Party):
Juscelino Tovar, 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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome X Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Other: Standard meal, bread/butter as starter Other: Standard meal with soup as starter Other: Standard meal with cheese as starter Other: Standard meal with salad as starter Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Meal Order on Postprandial Cardiometabolic Risk Markers
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.

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.

Experimental: 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).
Other: 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.

Experimental: 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).
Other: 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.

Experimental: 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).
Other: 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.




Primary Outcome Measures :
  1. Area under the curve of postprandial glycemia [ Time Frame: 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 :
  1. Area under the curve (AUC) of postprandial triglyceridemia [ Time Frame: 4 hours postprandial ]
    Area under the curve (AUC) of postprandial triglyceridemia (0-4h) after each intervention, compared to the reference meal

  2. Area under the curve (AUC) of postprandial insulinemia [ Time Frame: 4 hours postprandial ]
    Area under the curve (AUC) of postprandial insulinemia (0-4h) after each intervention, compared to the reference meal

  3. Area under the curve (AUC) of postprandial Glucagon-like peptide (GLP-1), Peptide YY (PYY) and glucose-dependent insulinotropic polypeptide (GIP) [ Time Frame: 4 hours ]
    Area under the curve (AUC) of postprandial GLP-1, GIP and PYY (0-4h) after each intervention, compared to the reference meal



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03358745


Locations
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Sweden
Antidiabetic Food Centre, Chemical Centre. Lund University
Lund, Skane, Sweden, 221 00
Food for Health Science Centre. Lund University Medicon Village
Lund, Sweden, SE 223 81
Sponsors and Collaborators
Lund University
Vinnova
Anti-Diabetic Food Centre

Publications:
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Responsible Party: Juscelino Tovar, Project Leader, Lund University
ClinicalTrials.gov Identifier: NCT03358745     History of Changes
Other Study ID Numbers: AFC2016-17.JT
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Juscelino Tovar, Lund University:
Type 2 diabetes risk
Cardiovascular disease risk

Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Metabolic Diseases
Glucose Metabolism Disorders
Hyperinsulinism