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Completed

NCT Number: NCT03358745

Impact of Meal Order on Postprandial Cardiometabolic Risk Markers

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antidiabetic Food Centre, Chemical Centre. Lund University, Lund, Skåne County, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard meal, bread/butter as starter

Other

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

Other

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

Other

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

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Lund University

Other

Collaborators

  • Anti-Diabetic Food Centre
  • Vinnova

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 2, 2017
Registry last updated
May 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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