Regulation, AppetiteNCT02516956
Impact of Different Breakfast Meals on Food Choices, Eating Behaviors and Brain Activation
A study testing Breakfast consumption, Blood tests and Food choices and energy intakes assessments in people with Regulation, Appetite and Eating Behavior, run by University of Parma at 1 site in Italy.
Trial summary
This project aims to demonstrate that the best breakfast meal is the one able to improve the best postprandial hunger, satiety and adiposity regulators profile as well as the best reward-related gratification, due to hedonistic parameters. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Regulation, Appetite, Eating Behavior, Cognition
- What is being tested?
- Breakfast consumption, Blood tests and Food choices and energy intakes assessments
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2014to Mar 2016
- 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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- both gender
- age 19 - 29 y
- BMI 20-24 kg ⁄m2
- healthy
- no metabolic, psychological, or neurological diseases/conditions
- not currently/previously (in the past 6 months) on a weight loss/other special diet
Show all 9Show fewer
- omnivorous
- chocolate eaters
- right-handed (necessary for the fMRI analyses)
Who cannot join
- BMI < 20 or BMI > 24 kg ⁄m2
- chronic health conditions
- use of medications
- significant change in body weight in the last 3 months
- currently on a diet/food restriction
- food allergy
Show all 12Show fewer
- celiac disease
- lactose intolerance
- left-handed
- claustrophobic
- do not meet the fMRI criteria established by the MU-BIC (regarding metal implants, etc.)
- pregnant
Trial locations and contacts
1 site in 1 country.
About this study
This project aims to demonstrate that the best breakfast meal is the one able to improve the best postprandial hunger, satiety and adiposity regulators profile as well as the best reward-related gratification, due to hedonistic parameters. To do this, 4 different breakfasts will be tested and blood tests, food choices, and attentional components will be analysed.
Read the detailed description
Although breakfast seems to be positively associated with healthy eating patterns and food choices later in the day, eating behaviours are a complex interaction of several factors. Nutritional requirements are not only affected by the body homeostasis, but also by environmental signals, as cultural and social habits, lifestyle, etc. These parameters evoke reward-related and motivational signals influencing our daily eating behaviour choices. Most of the theories on food regulation propose two parallel systems interacting with food consumption homeostatic and reward-related systems. For all these reasons, there is an increasing interest on motivational and decisional aspects of food choices, eating behaviours and how they are influenced by food characteristics. This project aims to explore the association between compositional and perceived characteristics of a breakfast meal with nutritional/biochemical/physiological variables. The approach will be the evaluation of appetite, food intake as well as metabolic and compensatory responses to foods consumed during the day. Volunteers (n=15) will be fed with 4 different breakfast meals (one control and three iso-caloric with different glycemic indexes) and several different parameters will be evaluated, as biological parameters linked to satiety, food choices during a free lunch buffet, psycho-physiological and biological mechanisms underlying the compensatory effect and attentional components in the postprandial period. The participants will complete, in randomized order, the four breakfast meals, on four different weeks, separated by at least one week.
- Conditions
- Regulation, Appetite, Eating Behavior, Cognition
- Being tested
- Breakfast consumption, Blood tests, Food choices and energy intakes assessments, Attention tests, fRMI tests
- Keywords
- Breakfast, Food choices, Lunch, Eating habits, Appetite, Neural activation, Attention, Glucose, Insulin, fMRI
- Medical subject headings
- Feeding Behavior, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breakfast consumptionOther
Participants will consume the assigned breakfast each morning for 7 days. Participants will express a hedonic rating of the breakfast through 7-point Likert Scales before (overview) and after breakfast consumption.
Blood testsOther
On the third day, participants will be involved in blood tests. Blood will be taken at baseline (fasting), and up to 4 hours after consuming the breakfast. Participants will complete serial visual analog rating scales of hunger and fullness before (fasting) and every 30 minutes up to 4 hours after breakfast consumption.
Food choices and energy intakes assessmentsOther
Following the last blood sample, participants will be given the opportunity to consume food ad libitum from a buffet lunch. Double weighing of food will be set up to evaluate food choices and energy intake of lunch. During the test week, participants will record all foods and beverage on a 7-day food dairy.
Attention testsOther
On the fourth day, 4 hours after the breakfast consumption and avoid other foods, participants will be involved in attentional test (Mackworth Clock Test for sustained attention and Stroop Test for selective attention).
fRMI testsOther
On the fifth day, 4 hours after the breakfast consumption and avoid other foods, participants will focus on a set of photographs (stimuli will be randomly choose from three categories of pictures including food, nonfood, and blurred baseline images) during an fMRI brain scan procedure to scan brain activation responses
| Study group | Role | What they receive |
|---|---|---|
| Breakfast meal 1 | Experimental | Breakfast meal 1 is isocaloric (330 kcal) and similar for protein and fiber contents in relation to the other two experimental breakfasts. It has the same sugar and lipid profiles as Breakfast meal 2 and health-related cognitive perception as Breakfast meal 3.
Breakfast consumption; Blood tests; Food choices and energy intakes assessments; Attention tests; fRMI tests. Receives: Other: Breakfast consumption; Other: Blood tests; Other: Food choices and energy intakes assessments; Other: Attention tests; Other: fRMI tests |
| Breakfast meal 2 | Experimental | Breakfast meal 2 is isocaloric (330 kcal) and balanced for protein and fiber contents with regard to the other two experimental breakfasts. It has the same sugar and lipid profiles as Breakfast meal 1 but a higher health-related cognitive perception than the other two experimental breakfasts.
Breakfast consumption; Blood tests; Food choices and energy intakes assessments; Attention tests; fRMI tests. Receives: Other: Breakfast consumption; Other: Blood tests; Other: Food choices and energy intakes assessments; Other: Attention tests; Other: fRMI tests |
| Breakfast meal 3 | Experimental | Breakfast meal 3 is isocaloric (330 kcal) and similar for protein and fiber contents in relation to the other two experimental breakfasts. It has the same health-related cognitive perception as Breakfast meal 1 but lower lipid and higher sugar amounts than the other two experimental breakfasts.
Breakfast consumption; Blood tests; Food choices and energy intakes assessments; Attention tests; fRMI tests. Receives: Other: Breakfast consumption; Other: Blood tests; Other: Food choices and energy intakes assessments; Other: Attention tests; Other: fRMI tests |
| Breakfast meal 4 | Placebo comparator | Breakfast meal 4 is a non-caloric meal representing fasting condition (control arm).
Breakfast consumption; Blood tests; Food choices and energy intakes assessments; Attention tests; fRMI tests. Receives: Other: Breakfast consumption; Other: Blood tests; Other: Food choices and energy intakes assessments; Other: Attention tests; Other: fRMI tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in biomarkers of appetite regulation in response to each breakfast:
- Glucose
- Insulin
- Ghrelin
- Leptin
- Peptide YY
- Glucagon-like peptide-1
- Non Esterified Fatty Acids
Measured: 4 hours (0 -12h fasting-, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes)
Secondary outcomes (6)
Hedonic rating of breakfast measured by 7-point Likert Scales
healthy, satiating, palatable, energizing and caloric perception
Measured: 2 times: 0-12h fasting- and 15 minutes after breakfast consumption
Self-reported appetite and satiety ratings measured by Visual Analog rating Scales
Measured: 0-12h fasting- and every 30 minutes up to 4 hours after breakfast consumption
Food choices at subsequent meal measured by double weighing of food during an ad libitum lunch buffet
Measured: 4 hours after breakfast conusmption
Daily Energy Intake measured by 7-day food dairy
Energy intake during breakfast, morning snacks, lunch, afternoon snacks, dinner, and evening snacks
Measured: 7 days
Post-prandial attention measured by Mackworth Clock Test and Stroop Test
sustained and selective attention
Measured: 4 hours after breakfast conusmption
Brain activation responses to images of food measured by fMRI brain scan
Measured: 4 hours after breakfast conusmption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study startJun 2014
- Primary completionJul 2015
- Study completionMar 2016
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 Regulation, AppetiteStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Furio Brighenti, University of Parma
- Investigators
- Furio Brighenti, Professor, Principal investigator, University of Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516956
- Sponsor's protocol ID
- BRNN-014
- Status last verified
- May 2016
- First submitted
- 31 Jul 2015
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Rosi A, Martini D, Scazzina F, Dall'Aglio E, Leonardi R, Monti L, Fasano F, Di Dio C, Riggio L, Brighenti F. Nature and Cognitive Perception of 4 Different Breakfast Meals Influence Satiety-Related Sensations and Postprandial Metabolic Responses but Have Little Effect on Food Choices and Intake Later in the Day in a Randomized Crossover Trial in Healthy Men. J Nutr. 2018 Oct 1;148(10):1536-1546. doi: 10.1093/jn/nxy160.
PubMed 30204905
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Different Breakfast Meals on Food Choices, Eating Behaviors and Brain Activation
- ClinicalTrials.gov ID
- NCT02516956
- Acronym / sponsor ID
- BRNN-014
- Conditions
- Regulation, Appetite, Eating Behavior, Cognition
- Keywords
- Breakfast, Food choices, Lunch, Eating habits, Appetite, Neural activation, Attention, Glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 6 Aug 2015 (estimated)
- 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.
This project aims to demonstrate that the best breakfast meal is the one able to improve the best postprandial hunger, satiety and adiposity regulators profile as well as the best reward-related gratification, due to hedonistic parameters. To do this, 4 different breakfasts will be tested and blood tests, food choices, and attentional components will be analysed.
Detailed description
Although breakfast seems to be positively associated with healthy eating patterns and food choices later in the day, eating behaviours are a complex interaction of several factors. Nutritional requirements are not only affected by the body homeostasis, but also by environmental signals, as cultural and social habits, lifestyle, etc. These parameters evoke reward-related and motivational signals influencing our daily eating behaviour choices. Most of the theories on food regulation propose two parallel systems interacting with food consumption homeostatic and reward-related systems. For all these reasons, there is an increasing interest on motivational and decisional aspects of food choices, eating behaviours and how they are influenced by food characteristics. This project aims to explore the association between compositional and perceived characteristics of a breakfast meal with nutritional/biochemical/physiological variables. The approach will be the evaluation of appetite, food intake as well as metabolic and compensatory responses to foods consumed during the day. Volunteers (n=15) will be fed with 4 different breakfast meals (one control and three iso-caloric with different glycemic indexes) and several different parameters will be evaluated, as biological parameters linked to satiety, food choices during a free lunch buffet, psycho-physiological and biological mechanisms underlying the compensatory effect and attentional components in the postprandial period. The participants will complete, in randomized order, the four breakfast meals, on four different weeks, separated by at least one week.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Breakfast meal 1 | Experimental | Other: Breakfast consumption, Other: Blood tests, Other: Food choices and energy intakes assessments, Other: Attention tests, Other: fRMI testsBreakfast meal 1 is isocaloric (330 kcal) and similar for protein and fiber contents in relation to the other two experimental breakfasts. It has the same sugar and lipid profiles as Breakfast meal 2 and health-related cognitive perception as Breakfast meal 3. Breakfast consumption; Blood tests; Food choices and energy intakes assessments; Attention tests; fRMI tests. |
| Breakfast meal 2 | Experimental | Other: Breakfast consumption, Other: Blood tests, Other: Food choices and energy intakes assessments, Other: Attention tests, Other: fRMI testsBreakfast meal 2 is isocaloric (330 kcal) and balanced for protein and fiber contents with regard to the other two experimental breakfasts. It has the same sugar and lipid profiles as Breakfast meal 1 but a higher health-related cognitive perception than the other two experimental breakfasts. Breakfast consumption; Blood tests; Food choices and energy intakes assessments; Attention tests; fRMI tests. |
| Breakfast meal 3 | Experimental | Other: Breakfast consumption, Other: Blood tests, Other: Food choices and energy intakes assessments, Other: Attention tests, Other: fRMI testsBreakfast meal 3 is isocaloric (330 kcal) and similar for protein and fiber contents in relation to the other two experimental breakfasts. It has the same health-related cognitive perception as Breakfast meal 1 but lower lipid and higher sugar amounts than the other two experimental breakfasts. Breakfast consumption; Blood tests; Food choices and energy intakes assessments; Attention tests; fRMI tests. |
| Breakfast meal 4 | Placebo comparator | Other: Breakfast consumption, Other: Blood tests, Other: Food choices and energy intakes assessments, Other: Attention tests, Other: fRMI testsBreakfast meal 4 is a non-caloric meal representing fasting condition (control arm). Breakfast consumption; Blood tests; Food choices and energy intakes assessments; Attention tests; fRMI tests. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- both gender
- age 19 - 29 y
- BMI 20-24 kg ⁄m2
- healthy
- no metabolic, psychological, or neurological diseases/conditions
Key exclusion criteria (12 listed)
- BMI < 20 or BMI > 24 kg ⁄m2
- chronic health conditions
- use of medications
- significant change in body weight in the last 3 months
- currently on a diet/food restriction
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 |
|---|---|---|
| Breakfast consumptionParticipants will consume the assigned breakfast each morning for 7 days. Participants will express a hedonic rating of the breakfast through 7-point Likert Scales before (overview) and after breakfast consumption. | Other | Breakfast meal 1, Breakfast meal 2, Breakfast meal 3, Breakfast meal 4 |
| Blood testsOn the third day, participants will be involved in blood tests. Blood will be taken at baseline (fasting), and up to 4 hours after consuming the breakfast. Participants will complete serial visual analog rating scales of hunger and fullness before (fasting) and every 30 minutes up to 4 hours after breakfast consumption. | Other | Breakfast meal 1, Breakfast meal 2, Breakfast meal 3, Breakfast meal 4 |
| Food choices and energy intakes assessmentsFollowing the last blood sample, participants will be given the opportunity to consume food ad libitum from a buffet lunch. Double weighing of food will be set up to evaluate food choices and energy intake of lunch. During the test week, participants will record all foods and beverage on a 7-day food dairy. | Other | Breakfast meal 1, Breakfast meal 2, Breakfast meal 3, Breakfast meal 4 |
| Attention testsOn the fourth day, 4 hours after the breakfast consumption and avoid other foods, participants will be involved in attentional test (Mackworth Clock Test for sustained attention and Stroop Test for selective attention). | Other | Breakfast meal 1, Breakfast meal 2, Breakfast meal 3, Breakfast meal 4 |
| fRMI testsOn the fifth day, 4 hours after the breakfast consumption and avoid other foods, participants will focus on a set of photographs (stimuli will be randomly choose from three categories of pictures including food, nonfood, and blurred baseline images) during an fMRI brain scan procedure to scan brain activation responses | Other | Breakfast meal 1, Breakfast meal 2, Breakfast meal 3, Breakfast meal 4 |
Primary outcome
Changes in biomarkers of appetite regulation in response to each breakfast:
Time frame: 4 hours (0 -12h fasting-, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes)
* Glucose * Insulin * Ghrelin * Leptin * Peptide YY * Glucagon-like peptide-1 * Non Esterified Fatty Acids
6 secondary outcomes
Hedonic rating of breakfast measured by 7-point Likert Scales
Time frame: 2 times: 0-12h fasting- and 15 minutes after breakfast consumption
Self-reported appetite and satiety ratings measured by Visual Analog rating Scales
Time frame: 0-12h fasting- and every 30 minutes up to 4 hours after breakfast consumption
Food choices at subsequent meal measured by double weighing of food during an ad libitum lunch buffet
Time frame: 4 hours after breakfast conusmption
Daily Energy Intake measured by 7-day food dairy
Time frame: 7 days
Post-prandial attention measured by Mackworth Clock Test and Stroop Test
Time frame: 4 hours after breakfast conusmption
Brain activation responses to images of food measured by fMRI brain scan
Time frame: 4 hours after breakfast conusmption
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 19 May 2016.
- Derived from this study: PubMed 30204905Rosi A, Martini D, Scazzina F, Dall'Aglio E, Leonardi R, Monti L, Fasano F, Di Dio C, Riggio L, Brighenti F. Nature and Cognitive Perception of 4 Different Breakfast Meals Influence Satiety-Related Sensations and Postprandial Metabolic Responses but Have Little Effect on Food Choices and Intake Later in the Day in a Randomized Crossover Trial in Healthy Men. J Nutr. 2018 Oct 1;148(10):1536-1546. doi: 10.1093/jn/nxy160.
- Individual participant dataSharing planned: Undecided
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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.
Furio Brighenti, Professor principal investigator
University of Parma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breakfast consumption, Blood tests and Food choices and energy intakes assessments in people with Regulation, Appetite and Eating Behavior, run by University of Parma at 1 site in Italy.
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 9 inclusion and 12 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 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Changes in biomarkers of appetite regulation in response to each breakfast: (time frame: 4 hours (0 -12h fasting-, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes)). 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 NCT02516956, 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 19 May 2016.