Metabolism and Nutrition DisorderNCT03240757
Metabolic and Functional Impact of Various Breakfast Models
A study testing Breakfast and exercise in people with Metabolism and Nutrition Disorder, run by Ospedale San Donato.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolism and Nutrition Disorder
- What is being tested?
- Breakfast and exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- 14 Jul 2009to 28 May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age between 18 and 40 years
- normal body weight (BMI =18.5 - 24.9 according to NHLBI)
- stable diet
Who cannot join
- Diabetes, tipe 1 and 2 (ADA criteria)
- Glucose intolerance (ADA criteria)
- Dyslipidemia (ATP III according to NCEP)
- Metabolic syndrome
About this study
Official title: Metabolic Responses of a Single Bout of Low-intensity Exercise Following Mixed Meals in Healthy Individuals
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.
Read the 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.
- Conditions
- Metabolism and Nutrition Disorder
- Being tested
- Breakfast, exercise
- Keywords
- meal absorption, exercise, energy balance, lipolysis
- Medical subject headings
- Nutrition Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreakfastDietary supplement
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.
exerciseOther
aerobic exercise at 40% of VO2max, for 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| Breakfast without exercise | Active comparator | Each subject of the same arm underwent 2 interventions: breakfast with/without exercise Receives: Dietary Supplement: Breakfast |
| Breakfast with exercise | Experimental | Each subject of the same arm underwent 2 interventions: breakfast with/without exercise Receives: Dietary Supplement: Breakfast; Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start14 Jul 2009
- Primary completion28 May 2010
- Study completion28 May 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolism and Nutrition DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized-crossover in healthy subjects
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale San Donato
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milan
- Responsible party
- Principal investigator, Livio Luzi, Ospedale San Donato
- Investigators
- Livio Luzi, M.D., Principal investigator, Gruppo San Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240757
- Sponsor's protocol ID
- Colazioni/1
- Status last verified
- Aug 2017
- First submitted
- 1 Aug 2017
- Last updated
- 7 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified collective participant data for all outcome measures will be made available upon publication
Publications
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).
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Responses of a Single Bout of Low-intensity Exercise Following Mixed Meals in Healthy Individuals
- ClinicalTrials.gov ID
- NCT03240757
- Acronym / sponsor ID
- Colazioni/1
- Conditions
- Metabolism and Nutrition Disorder
- Keywords
- meal absorption, exercise, energy balance, lipolysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Ospedale San DonatoUniversity, hospital or other
- Collaborators
- University of Milan
- Study start
- 14 Jul 2009 (actual)
- Primary completion
- 28 May 2010 (actual)
- Study completion
- 28 May 2010 (actual)
- First posted
- 7 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized-crossover in healthy subjects
| Arm | Type | Receives |
|---|---|---|
| Breakfast without exercise | Active comparator | Dietary Supplement: BreakfastEach subject of the same arm underwent 2 interventions: breakfast with/without exercise |
| Breakfast with exercise | Experimental | Dietary Supplement: Breakfast, Other: exerciseEach subject of the same arm underwent 2 interventions: breakfast with/without exercise |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age between 18 and 40 years
- normal body weight (BMI =18.5 - 24.9 according to NHLBI)
- stable diet
Key exclusion criteria (4 listed)
- Diabetes, tipe 1 and 2 (ADA criteria)
- Glucose intolerance (ADA criteria)
- Dyslipidemia (ATP III according to NCEP)
- Metabolic syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BreakfastAll 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. | Dietary supplement | Breakfast with exercise, Breakfast without exercise |
| exerciseaerobic exercise at 40% of VO2max, for 20 minutes | Other | Breakfast with exercise |
Primary outcome
Plasma glucose responses of a single bout of low-intensity exercise following mixed meals in healthy individuals.
Time frame: The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).
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.
Time frame: The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).
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.
Time frame: The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).
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.
Time frame: The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).
Postprandial plasma FFA responses elicited by three diverse test-meal loads followed by a 20-min bout of low-intensity aerobic exercise.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2017.
- Results publicationR 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).
- Individual participant dataSharing planned: No. De-identified collective participant data for all outcome measures will be made available upon publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Livio Luzi, M.D. principal investigator
Gruppo San Donato
Questions about this trial
What is this clinical trial studying?
A study testing Breakfast and exercise in people with Metabolism and Nutrition Disorder, run by Ospedale San Donato.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma glucose responses of a single bout of low-intensity exercise following mixed meals in healthy individuals. (time frame: The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03240757, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2017.