An interventional study of Breakfast consumption and Blood tests in Regulation, Appetite, Eating Behavior and Cognition, sponsored by University of Parma. Completed at 1 site in Italy. Open to participants aged 20 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-19.
Sponsored by University of Parma · Not applicable, Interventional, and Basic science
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.
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.
243 studies on the registry are indexed under Feeding Behavior; 101 are open to participants now.
This study's enrollment of 15 is below the median of 80 across 181 interventional studies indexed under Feeding Behavior.
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Exclusion Criteria:
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.
Other: Breakfast consumption · Other: Blood tests · Other: Food choices and energy intakes assessments · Other: Attention tests · Other: fRMI tests
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.
Other: Breakfast consumption · Other: Blood tests · Other: Food choices and energy intakes assessments · Other: Attention tests · Other: fRMI tests
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.
Other: Breakfast consumption · Other: Blood tests · Other: Food choices and energy intakes assessments · Other: Attention tests · Other: fRMI tests
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.
Other: Breakfast consumption · Other: Blood tests · Other: Food choices and energy intakes assessments · Other: Attention tests · Other: 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
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
Time frame: 4 hours (0 -12h fasting-, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes)
Hedonic rating of breakfast measured by 7-point Likert Scales
healthy, satiating, palatable, energizing and caloric perception
Time frame: 2 times: 0-12h fasting- and 15 minutes after breakfast consumption
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
Food choices at subsequent meal measured by double weighing of food during an ad libitum lunch buffet
Time frame: 4 hours after breakfast conusmption
Daily Energy Intake measured by 7-day food dairy
Energy intake during breakfast, morning snacks, lunch, afternoon snacks, dinner, and evening snacks
Time frame: 7 days
Post-prandial attention measured by Mackworth Clock Test and Stroop Test
sustained and selective attention
Time frame: 4 hours after breakfast conusmption
Brain activation responses to images of food measured by fMRI brain scan
Time frame: 4 hours after breakfast conusmption
Plan to share: Undecided
The record gives a start of Jun 2014, a primary completion of Jul 2015 and a completion of Mar 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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University of Parma