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Metabolic and Neurofunctional Responses to Breakfasts

Effect of Glucose Versus Mixed Breakfast on Metabolic and Neurofunctional Responses in Healthy Individuals

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02897570
Enrollment
12
Registered
2016-09-13
Start date
2013-10-31
Completion date
2014-12-31
Last updated
2016-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit and Disruptive Behavior Disorders, Feeding Behaviors, Lack of Satiety

Keywords

ghrelin, breakfast meal, P-300

Brief summary

This study aims at assessing the effects of glucose and different types of breakfast on metabolic and neurofunctional responses in healthy individuals. Twelve healthy subjects, on a stable diet, in a randomized-crossover fashion, received either a 50 g glucose load (control) or one of these breakfast: B1: milk (125ml) and cereals (30g); B2: milk (220ml), apple (200g) and cream chocolate filled sponge cake (30g); B3: milk (125ml), bread (50g), apple (150g) and hazelnut cream chocolate (15g). Prior and upon completion of each tolerance test, an EEG was performed to measure frontal P300-evoked potentials.

Interventions

DIETARY_SUPPLEMENTGlucose

50g of glucose dissolved in 250 to 300ml of water was drunk. Prior and upon completion of each glucose tolerance test, an EEG was performed.

DIETARY_SUPPLEMENTMilk & Cereals

A breakfast (B1) including a glass of milk (125ml) and 30 g-corn flakes was consumed. Prior and upon completion of each tolerance test, an EEG was performed

DIETARY_SUPPLEMENTMilk, apple & snack

A breakfast (B2) including a glass of milk (220ml), an apple (200g), a cream chocolate filled sponge cake (30g) was consumed. Prior and upon completion of each meal tolerance test, an EEG was performed.

DIETARY_SUPPLEMENTMilk, apple & bread w/ cream

A breakfast (B3) including a glass of milk (125ml), an apple (150g), bread (50g, hazelnut chocolate cream (15g) was consumed. Prior and upon completion of each meal tolerance test, an EEG was performed.

DEVICEEEG_pre

Electroencephalography (EEG) was performed prior each tolerance test to assess frontal P300-evoked potentials

DEVICEEEG_post

Electroencephalography (EEG) was performed upon completion of each tolerance test to assess frontal P300-evoked potentials

Sponsors

Soremartec Italia S.r.l.
CollaboratorUNKNOWN
Ospedale San Donato
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* BMI 18.5 - 24.9 kg/m2 * normal glucose tolerance * stable diet

Exclusion criteria

* type 1 and type 2 diabetes * impaired glucose tolerance * dyslipidemia * metabolic syndrome

Design outcomes

Primary

MeasureTime frameDescription
Effect of glucose vs different kind of breakfasts on cognitive performances via brain evoked-potentials measureThe incremental (post-pre) frontal P300 potential was assessed as a change ( before and 180 min after consumption)On the same morning of the glucose tolerance test, before and 180 min after consumption, an EEG was performed to record P300 wave-evoked potentials.

Secondary

MeasureTime frameDescription
Effect of glucose vs different kind of breakfasts on AUC_glycemia in healthy subjectsBlood samples are drawn at -15, 0, 15, 30, 45, 60, 75, 90, 120 minutes with respect to the ingestion.The incremental area under plasma glucose concentration curve (AUC\_glycemia) was used as summary measures of the metabolic responses resulting from the intake of either glucose or one of the 3 breakfasts. The incremental AUC was calculated as the difference between the total AUC and the product of the basal, pre-test concentration time during the experiment (i.e., 120 min).
Effect of glucose vs different kind of breakfasts on AUC_ghrelinemia in healthy subjects.Blood samples are drawn at -15, 0, 15, 30, 45, 60, 75, 90, 120 minutes with respect to the ingestion.The incremental area under plasma ghrelin concentration curve (AUC\_ghrelinemia) was used as summary measures of the metabolic responses resulting from the intake of either glucose or one of the 3 breakfasts. The incremental AUC was calculated as the difference between the total AUC and the product of the basal, pre-test concentration time during the experiment (i.e., 120 min).
Effect of glucose vs different kind of breakfasts on AUC_insulinemia in healthy subjects.Blood samples are drawn at -15, 0, 15, 30, 45, 60, 75, 90, 120 minutes with respect to the ingestion.The incremental area under plasma insulim concentration curve (AUC\_insulinemia) was used as summary measures of the metabolic responses resulting from the intake of either glucose or one of the 3 breakfasts. The incremental AUC was calculated as the difference between the total AUC and the product of the basal, pre-test concentration time during the experiment (i.e., 120 min).

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026