Metabolic and Neurofunctional Responses to Breakfasts

Not Applicable

Completed

• Conditions: Lack of Satiety; Attention Deficit and Disruptive Behavior Disorders; Feeding Behaviors
• Interventions: Dietary Supplement: Glucose; Dietary Supplement: Milk & Cereals; Dietary Supplement: Milk, apple & snack; Dietary Supplement: Milk, apple & bread w/ cream; Device: EEG_pre; Device: EEG_post

• Registration Number: NCT02897570
• Lead Sponsor: Ospedale San Donato

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Study First Submitted: 2016-08-26
• Status Verified: 2016-09
• Study First Submitted QC: 2016-09-12
• Study First Posted: 2016-09-13
• Last Update Submitted: 2016-09-13
• Last Update Posted: 2016-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Glucose	Glucose	EEG_pre + Oral glucose tolerance test (50-g OGTT) + EEG_post
Milk + Apple + Snack	EEG_pre	EEG_pre + B2: milk (220ml), apple (200g) and cream chocolate filled sponge cake (30g) + EEG_post
Milk + Apple + Bread w/ cream	EEG_pre	EEG_pre + B3: milk (125ml), apple (150g), and bread (50g) with hazelnut chocolate cream (15g) + EEG_post
Glucose	EEG_pre	EEG_pre + Oral glucose tolerance test (50-g OGTT) + EEG_post
Glucose	EEG_post	EEG_pre + Oral glucose tolerance test (50-g OGTT) + EEG_post
Milk + Apple + Bread w/ cream	EEG_post	EEG_pre + B3: milk (125ml), apple (150g), and bread (50g) with hazelnut chocolate cream (15g) + EEG_post
Milk + Cereals	Milk & Cereals	EEG_pre + B1: milk (125ml) and cereals (30g) + EEG_post
Milk + Cereals	Milk, apple & snack	EEG_pre + B1: milk (125ml) and cereals (30g) + EEG_post
Milk + Apple + Snack	Milk & Cereals	EEG_pre + B2: milk (220ml), apple (200g) and cream chocolate filled sponge cake (30g) + EEG_post
Milk + Apple + Snack	EEG_post	EEG_pre + B2: milk (220ml), apple (200g) and cream chocolate filled sponge cake (30g) + EEG_post
Milk + Apple + Bread w/ cream	Milk, apple & bread w/ cream	EEG_pre + B3: milk (125ml), apple (150g), and bread (50g) with hazelnut chocolate cream (15g) + EEG_post
Milk + Cereals	EEG_pre	EEG_pre + B1: milk (125ml) and cereals (30g) + EEG_post
Milk + Apple + Snack	Milk, apple & bread w/ cream	EEG_pre + B2: milk (220ml), apple (200g) and cream chocolate filled sponge cake (30g) + EEG_post
Milk + Cereals	EEG_post	EEG_pre + B1: milk (125ml) and cereals (30g) + EEG_post
Milk + Apple + Bread w/ cream	Milk & Cereals	EEG_pre + B3: milk (125ml), apple (150g), and bread (50g) with hazelnut chocolate cream (15g) + EEG_post

Primary Outcome Measures

Name	Time	Method
Effect of glucose vs different kind of breakfasts on cognitive performances via brain evoked-potentials measure	The 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 Outcome Measures

Name	Time	Method
Effect of glucose vs different kind of breakfasts on AUC_glycemia 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 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).

Trial Locations

Locations (1)

San Donato Hospital; 🇮🇹 San Donato Milanese, MI, Italy