Clinical trial NCT02516956: Impact of Different Breakfast Meals on Food Choices, Eating Behaviors and Brain Activation
Official title: Impact of Different Breakfast Meals on Food Choices, Eating Behaviors and Brain Activation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Regulation, Appetite
Eating Behavior
Cognition
Keywords: Breakfast
Food choices
Lunch
Eating habits
Appetite
Neural activation
Attention
Glucose
Insulin
fMRI
Lead sponsor: University of Parma
Sponsor class: OTHER
First posted: 2015-08-06
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in biomarkers of appetite regulation in response to each breakfast:
timeFrame: 4 hours (0 -12h fasting-, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes)
Secondary outcomes:
measure: Hedonic rating of breakfast measured by 7-point Likert Scales
timeFrame: 2 times: 0-12h fasting- and 15 minutes after breakfast consumption
measure: Self-reported appetite and satiety ratings measured by Visual Analog rating Scales
timeFrame: 0-12h fasting- and every 30 minutes up to 4 hours after breakfast consumption
measure: Food choices at subsequent meal measured by double weighing of food during an ad libitum lunch buffet
timeFrame: 4 hours after breakfast conusmption
measure: Daily Energy Intake measured by 7-day food dairy
timeFrame: 7 days
measure: Post-prandial attention measured by Mackworth Clock Test and Stroop Test
timeFrame: 4 hours after breakfast conusmption
measure: Brain activation responses to images of food measured by fMRI brain scan
timeFrame: 4 hours after breakfast conusmption
Other outcomes:
Locations:
city: Parma
country: Italy
facility: University of Parma
state: PR
Study officials:
affiliation: University of Parma
name: Furio Brighenti, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.