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Metabolic and Functional Impact of Various Breakfast Models

Primary Purpose

Metabolism and Nutrition Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Breakfast
exercise
Sponsored by
Ospedale San Donato
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Metabolism and Nutrition Disorder focused on measuring meal absorption, exercise, energy balance, lipolysis

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age between 18 and 40 years
  • normal body weight (BMI =18.5 - 24.9 according to NHLBI)
  • stable diet

Exclusion Criteria:

  • Diabetes, tipe 1 and 2 (ADA criteria)
  • Glucose intolerance (ADA criteria)
  • Dyslipidemia (ATP III according to NCEP)
  • Metabolic syndrome

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Breakfast without exercise

    Breakfast with exercise

    Arm Description

    Each subject of the same arm underwent 2 interventions: breakfast with/without exercise

    Each subject of the same arm underwent 2 interventions: breakfast with/without exercise

    Outcomes

    Primary Outcome Measures

    Plasma glucose responses of a single bout of low-intensity exercise following mixed meals in healthy individuals.
    Postprandial glycemic responses elicited by three diverse test-meal loads followed by a 20-min bout of low-intensity aerobic exercise.
    Plasma insulin responses of a single bout of low-intensity exercise following mixed meals in healthy individuals.
    Postprandial insulinemic responses elicited by three diverse test-meal loads followed by a 20-min bout of low-intensity aerobic exercise.
    Plasma ghrelin responses of a single bout of low-intensity exercise following mixed meals in healthy individuals.
    Postprandial ghrelinemic responses elicited by three diverse test-meal loads followed by a 20-min bout of low-intensity aerobic exercise.
    Plasma free fatty acids (FFA) responses of a single bout of low-intensity exercise following mixed meals in healthy individuals.
    Postprandial plasma FFA responses elicited by three diverse test-meal loads followed by a 20-min bout of low-intensity aerobic exercise.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 1, 2017
    Last Updated
    August 4, 2017
    Sponsor
    Ospedale San Donato
    Collaborators
    University of Milan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03240757
    Brief Title
    Metabolic and Functional Impact of Various Breakfast Models
    Official Title
    Metabolic Responses of a Single Bout of Low-intensity Exercise Following Mixed Meals in Healthy Individuals
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 14, 2009 (Actual)
    Primary Completion Date
    May 28, 2010 (Actual)
    Study Completion Date
    May 28, 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ospedale San Donato
    Collaborators
    University of Milan

    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
    In the present study the investigators compared the hormonal and metabolic effects of three meal loads very popular among Italian eating habits, both in the resting- and exercising state. Given the lack of time is considered a common barrier to exercise adherence, we wanted to identify a low dose of exercise capable to produce health benefits in the post-absorptive status elicited by three commonly consumed meal-models in Mediterranean countries. To this end, healthy young volunteers firstly underwent an oral glucose tolerance test (OGTT) and three meal tolerance tests. Secondly, in an extra set of experiments, subjects cycled at low intensity for the last 20 minutes of the same glucose/meal tolerance test. Glycemia, insulinemia, ghrelinemia, lipidemia, and satiety were measured throughout OGTT and each test-meal load.
    Detailed Description
    The investigators evaluated postprandial responses (glucose, insulin, ghrelin, free fatty acids (FFA)) elicited by three diverse test-meal loads followed by a 20-min bout of low-intensity aerobic exercise were investigated. All subjects underwent a 50-g OGTT (A) and 3 test-meal loads: milk and cereals (B1); milk, apple and chocolate cream-filled sponge cake (B2); milk, bread, apple and hazelnut chocolate cream (B3). In the exercise trial, participants cycled for 20 minutes at 40% VO2max, 100 minutes after load ingestion.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolism and Nutrition Disorder
    Keywords
    meal absorption, exercise, energy balance, lipolysis

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    randomized-crossover in healthy subjects
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    19 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Breakfast without exercise
    Arm Type
    Active Comparator
    Arm Description
    Each subject of the same arm underwent 2 interventions: breakfast with/without exercise
    Arm Title
    Breakfast with exercise
    Arm Type
    Experimental
    Arm Description
    Each subject of the same arm underwent 2 interventions: breakfast with/without exercise
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Breakfast
    Intervention Description
    All subjects received a standard 75-g OGTT to assess eligibility for the study. The 19 subjects matching the inclusion criteria completed 2 experimental trials: resting and exercise. During the resting trial, all subjects underwent an OGTT (50-g: A) and 3 meal tolerance tests [one for each breakfast tested: B1 = milk (125ml) and cereals (30g); B2 = milk (220ml), apple (200g) and chocolate cream-filled sponge cake (30g); B3 = milk (125ml), apple (150g), bread (50g) and hazelnut chocolate cream (15g)]. In the exercise trial, 100 minutes after the glucose/meal ingestion, participants cycled for 20 min at 40% of maximum oxygen uptake.
    Intervention Type
    Other
    Intervention Name(s)
    exercise
    Intervention Description
    aerobic exercise at 40% of VO2max, for 20 minutes
    Primary Outcome Measure Information:
    Title
    Plasma glucose responses of a single bout of low-intensity exercise following mixed meals in healthy individuals.
    Description
    Postprandial glycemic responses elicited by three diverse test-meal loads followed by a 20-min bout of low-intensity aerobic exercise.
    Time Frame
    The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).
    Title
    Plasma insulin responses of a single bout of low-intensity exercise following mixed meals in healthy individuals.
    Description
    Postprandial insulinemic responses elicited by three diverse test-meal loads followed by a 20-min bout of low-intensity aerobic exercise.
    Time Frame
    The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).
    Title
    Plasma ghrelin responses of a single bout of low-intensity exercise following mixed meals in healthy individuals.
    Description
    Postprandial ghrelinemic responses elicited by three diverse test-meal loads followed by a 20-min bout of low-intensity aerobic exercise.
    Time Frame
    The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).
    Title
    Plasma free fatty acids (FFA) responses of a single bout of low-intensity exercise following mixed meals in healthy individuals.
    Description
    Postprandial plasma FFA responses elicited by three diverse test-meal loads followed by a 20-min bout of low-intensity aerobic exercise.
    Time Frame
    The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: age between 18 and 40 years normal body weight (BMI =18.5 - 24.9 according to NHLBI) stable diet Exclusion Criteria: Diabetes, tipe 1 and 2 (ADA criteria) Glucose intolerance (ADA criteria) Dyslipidemia (ATP III according to NCEP) Metabolic syndrome
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Livio Luzi, M.D.
    Organizational Affiliation
    Gruppo San Donato
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    De-identified collective participant data for all outcome measures will be made available upon publication
    Citations:
    Citation
    R Codella, A Caumo, S Benedini, M Adamo, A Ferrulli, C Macrì, I Terruzzi, L Luzi. Metabolic responses of a single bout of low-intensity exercise following mixed meals in healthy individuals. ADA (American Diabetes Association) 77th Scientific Session, 8-13 giugno 2017, San Diego, CA, USA. Diabetes 2017 Jun; 66 (Supplement 1).
    Results Reference
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    Metabolic and Functional Impact of Various Breakfast Models

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