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Trial record 101 of 406 for:    PYY

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

Tracking Information
First Submitted Date  ICMJE November 27, 2017
First Posted Date  ICMJE December 2, 2017
Last Update Posted Date May 9, 2019
Actual Study Start Date  ICMJE June 1, 2016
Actual Primary Completion Date March 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03358745 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2017)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Meal Order on Postprandial Cardiometabolic Risk Markers
Official Title  ICMJE Impact of Meal Order on Postprandial Cardiometabolic Risk Markers
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Metabolic Syndrome X
  • Insulin Resistance
  • Hyperinsulinism
  • Glucose Metabolism Disorders
  • Metabolic Diseases
Intervention  ICMJE
  • 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.
  • 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.
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.

    Intervention: Other: Standard meal, bread/butter as starter
  • 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).
    Intervention: Other: Standard meal with soup as starter
  • 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).
    Intervention: Other: Standard meal with cheese as starter
  • 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).
    Intervention: Other: Standard meal with salad as starter
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2017)
21
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 1, 2018
Actual Primary Completion Date March 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03358745
Other Study ID Numbers  ICMJE AFC2016-17.JT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Juscelino Tovar, Lund University
Study Sponsor  ICMJE Lund University
Collaborators  ICMJE
  • Vinnova
  • Anti-Diabetic Food Centre
Investigators  ICMJE Not Provided
PRS Account Lund University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP