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Completed

NCT Number: NCT02516956

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

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.

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Key information

Conditions

Regulation, Appetite Behavior Behavior, Animal Cognition Eating Behavior Feeding Behavior Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Parma

Parma, PR, 43125, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breakfast consumption

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

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

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

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

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Food choices at subsequent meal measured by double weighing of food during an ad libitum lunch buffet

    Time frame: 4 hours after breakfast conusmption

  4. Daily Energy Intake measured by 7-day food dairy

    Time frame: 7 days

    Energy intake during breakfast, morning snacks, lunch, afternoon snacks, dinner, and evening snacks

  5. Post-prandial attention measured by Mackworth Clock Test and Stroop Test

    Time frame: 4 hours after breakfast conusmption

    sustained and selective attention

  6. Brain activation responses to images of food measured by fMRI brain scan

    Time frame: 4 hours after breakfast conusmption

Sponsors and collaborators

Lead sponsor

University of Parma

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Aug 6, 2015
Registry last updated
May 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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