Impact of Different Breakfast Meals on Food Choices, Eating Behaviors and Brain Activation

Eating Behavior Clinical Trial

Official title:

Impact of Different Breakfast Meals on Food Choices, Eating Behaviors and Brain Activation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02516956
• Other study ID #: BRNN-014
• Status: Completed
• Phase: N/A
• First received: July 31, 2015
• Last updated: May 18, 2016
• Start date: June 2014
• Est. completion date: March 2016

Study information

• Verified date: May 2016
• Source: University of Parma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical 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. To do this, 4 different breakfasts will be tested and blood tests, food choices, and attentional components will be analysed.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 30 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cognition
• Eating Behavior
• Regulation, Appetite

Intervention

Other:
• Breakfast consumption
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 tests
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 assessments
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 tests
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 tests
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

Locations

Country	Name	City	State
Italy	University of Parma	Parma	PR

Sponsors (1)

Lead Sponsor	Collaborator
University of Parma

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 hours (0 -12h fasting-, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes)	No
Secondary	Hedonic rating of breakfast measured by 7-point Likert Scales	healthy, satiating, palatable, energizing and caloric perception	2 times: 0-12h fasting- and 15 minutes after breakfast consumption	No
Secondary	Self-reported appetite and satiety ratings measured by Visual Analog rating Scales		0-12h fasting- and every 30 minutes up to 4 hours after breakfast consumption	No
Secondary	Food choices at subsequent meal measured by double weighing of food during an ad libitum lunch buffet		4 hours after breakfast conusmption	No
Secondary	Daily Energy Intake measured by 7-day food dairy	Energy intake during breakfast, morning snacks, lunch, afternoon snacks, dinner, and evening snacks	7 days	No
Secondary	Post-prandial attention measured by Mackworth Clock Test and Stroop Test	sustained and selective attention	4 hours after breakfast conusmption	No
Secondary	Brain activation responses to images of food measured by fMRI brain scan		4 hours after breakfast conusmption	No