- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02516956
Impact of Different Breakfast Meals on Food Choices, Eating Behaviors and Brain Activation
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
PR
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Parma, PR, Italy, 43125
- University of Parma
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- omnivorous
- chocolate eaters
- right-handed (necessary for the fMRI analyses)
Exclusion Criteria:
- 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
- celiac disease
- lactose intolerance
- left-handed
- claustrophobic
- do not meet the fMRI criteria established by the MU-BIC (regarding metal implants, etc.)
- pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Breakfast meal 1
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. |
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.
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.
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.
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).
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
|
Experimental: Breakfast meal 2
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. |
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.
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.
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.
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).
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
|
Experimental: Breakfast meal 3
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. |
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.
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.
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.
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).
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
|
Placebo Comparator: Breakfast meal 4
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. |
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.
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.
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.
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).
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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|
4 hours (0 -12h fasting-, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hedonic rating of breakfast measured by 7-point Likert Scales
Time Frame: 2 times: 0-12h fasting- and 15 minutes after breakfast consumption
|
healthy, satiating, palatable, energizing and caloric perception
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2 times: 0-12h fasting- and 15 minutes after breakfast consumption
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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
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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
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4 hours after breakfast conusmption
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|
Daily Energy Intake measured by 7-day food dairy
Time Frame: 7 days
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Energy intake during breakfast, morning snacks, lunch, afternoon snacks, dinner, and evening snacks
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7 days
|
Post-prandial attention measured by Mackworth Clock Test and Stroop Test
Time Frame: 4 hours after breakfast conusmption
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sustained and selective attention
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4 hours after breakfast conusmption
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Brain activation responses to images of food measured by fMRI brain scan
Time Frame: 4 hours after breakfast conusmption
|
4 hours after breakfast conusmption
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Furio Brighenti, Professor, University of Parma
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BRNN-014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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