Metabolic and Functional Impact of Various Breakfast Models
Metabolic Responses of a Single Bout of Low-intensity Exercise Following Mixed Meals in Healthy Individuals
1 other identifier
interventional
19
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2009
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 14, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 28, 2010
CompletedFirst Submitted
Initial submission to the registry
August 1, 2017
CompletedFirst Posted
Study publicly available on registry
August 7, 2017
CompletedAugust 7, 2017
August 1, 2017
11 months
August 1, 2017
August 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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.
The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).
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.
The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).
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.
The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).
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.
The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).
Study Arms (2)
Breakfast without exercise
ACTIVE COMPARATOREach subject of the same arm underwent 2 interventions: breakfast with/without exercise
Breakfast with exercise
EXPERIMENTALEach subject of the same arm underwent 2 interventions: breakfast with/without exercise
Interventions
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.
Eligibility Criteria
You may qualify if:
- age between 18 and 40 years
- normal body weight (BMI =18.5 - 24.9 according to NHLBI)
- stable diet
You may not qualify if:
- Diabetes, tipe 1 and 2 (ADA criteria)
- Glucose intolerance (ADA criteria)
- Dyslipidemia (ATP III according to NCEP)
- Metabolic syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ospedale San Donatolead
- University of Milancollaborator
Related Publications (1)
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).
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Livio Luzi, M.D.
Gruppo San Donato
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., Full Professor of Endocrinology
Study Record Dates
First Submitted
August 1, 2017
First Posted
August 7, 2017
Study Start
July 14, 2009
Primary Completion
May 28, 2010
Study Completion
May 28, 2010
Last Updated
August 7, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share
De-identified collective participant data for all outcome measures will be made available upon publication