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

NCT ID: NCT02516956

Last Updated: 2016-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-03-31

Brief Summary

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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

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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

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Regulation, Appetite Eating Behavior Cognition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Breakfast consumption

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Breakfast consumption

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Breakfast consumption

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

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.

Group Type PLACEBO_COMPARATOR

Breakfast consumption

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

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).

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Parma

OTHER

Sponsor Role lead

Responsible Party

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Professor Furio Brighenti

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Furio Brighenti, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Parma

Locations

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University of Parma

Parma, PR, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 30204905 (View on PubMed)

Other Identifiers

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BRNN-014

Identifier Type: -

Identifier Source: org_study_id

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