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
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
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
NCT ID
NCT03240757
First Posted
August 1, 2017
Last Updated
August 4, 2017
Sponsor
Ospedale San Donato
Collaborators
University of Milan
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
result
Learn more about this trial
Metabolic and Functional Impact of Various Breakfast Models
We'll reach out to this number within 24 hrs