NCT02516956

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 6, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

May 19, 2016

Status Verified

May 1, 2016

Enrollment Period

1.1 years

First QC Date

July 31, 2015

Last Update Submit

May 18, 2016

Conditions

Regulation, AppetiteEating BehaviorCognition

Keywords

BreakfastFood choicesLunchEating habitsAppetiteNeural activationAttentionGlucoseInsulinfMRI

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (6)

  • Hedonic rating of breakfast measured by 7-point Likert Scales

    2 times: 0-12h fasting- and 15 minutes after breakfast consumption

  • 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

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

    4 hours after breakfast conusmption

  • Daily Energy Intake measured by 7-day food dairy

    7 days

  • Post-prandial attention measured by Mackworth Clock Test and Stroop Test

    4 hours after breakfast conusmption

  • +1 more secondary outcomes

Study Arms (4)

Breakfast meal 1

EXPERIMENTAL

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 consumptionOther: Blood testsOther: Food choices and energy intakes assessmentsOther: Attention testsOther: fRMI tests

Breakfast meal 2

EXPERIMENTAL

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 consumptionOther: Blood testsOther: Food choices and energy intakes assessmentsOther: Attention testsOther: fRMI tests

Breakfast meal 3

EXPERIMENTAL

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 consumptionOther: Blood testsOther: Food choices and energy intakes assessmentsOther: Attention testsOther: fRMI tests

Breakfast meal 4

PLACEBO COMPARATOR

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 consumptionOther: Blood testsOther: Food choices and energy intakes assessmentsOther: Attention testsOther: fRMI tests

Interventions

Breakfast consumptionOTHER

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.

Breakfast meal 1Breakfast meal 2Breakfast meal 3Breakfast meal 4
Blood testsOTHER

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.

Breakfast meal 1Breakfast meal 2Breakfast meal 3Breakfast meal 4
Food choices and energy intakes assessmentsOTHER

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.

Breakfast meal 1Breakfast meal 2Breakfast meal 3Breakfast meal 4
Attention testsOTHER

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).

Breakfast meal 1Breakfast meal 2Breakfast meal 3Breakfast meal 4
fRMI testsOTHER

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 1Breakfast meal 2Breakfast meal 3Breakfast meal 4

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Parma

Parma, PR, 43125, Italy

Location

Related Publications (1)

  • 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.

    PMID: 30204905DERIVED

MeSH Terms

Conditions

Feeding BehaviorInsulin Resistance

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Furio Brighenti, Professor

    University of Parma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 31, 2015

First Posted

August 6, 2015

Study Start

June 1, 2014

Primary Completion

July 1, 2015

Study Completion

March 1, 2016

Last Updated

May 19, 2016

Record last verified: 2016-05

Locations

IT(1)