Metabolic and Neurofunctional Responses to Breakfasts

NCT ID: NCT02897570

Last Updated: 2016-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Feeding Behaviors Lack of Satiety Attention Deficit and Disruptive Behavior Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Glucose

EEG\_pre + Oral glucose tolerance test (50-g OGTT) + EEG\_post

Group Type ACTIVE_COMPARATOR

Glucose

Intervention Type DIETARY_SUPPLEMENT

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.

EEG_pre

Intervention Type DEVICE

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

EEG_post

Intervention Type DEVICE

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

Milk + Cereals

EEG\_pre + B1: milk (125ml) and cereals (30g) + EEG\_post

Group Type EXPERIMENTAL

Milk & Cereals

Intervention Type DIETARY_SUPPLEMENT

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

Milk, apple & snack

Intervention Type DIETARY_SUPPLEMENT

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.

EEG_pre

Intervention Type DEVICE

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

EEG_post

Intervention Type DEVICE

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

Milk + Apple + Snack

EEG\_pre + B2: milk (220ml), apple (200g) and cream chocolate filled sponge cake (30g) + EEG\_post

Group Type EXPERIMENTAL

Milk & Cereals

Intervention Type DIETARY_SUPPLEMENT

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

Milk, apple & bread w/ cream

Intervention Type DIETARY_SUPPLEMENT

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.

EEG_pre

Intervention Type DEVICE

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

EEG_post

Intervention Type DEVICE

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

Milk + Apple + Bread w/ cream

EEG\_pre + B3: milk (125ml), apple (150g), and bread (50g) with hazelnut chocolate cream (15g) + EEG\_post

Group Type EXPERIMENTAL

Milk & Cereals

Intervention Type DIETARY_SUPPLEMENT

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

Milk, apple & bread w/ cream

Intervention Type DIETARY_SUPPLEMENT

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.

EEG_pre

Intervention Type DEVICE

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

EEG_post

Intervention Type DEVICE

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

Interventions

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Glucose

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.

Intervention Type DIETARY_SUPPLEMENT

Milk & 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

Intervention Type DIETARY_SUPPLEMENT

Milk, 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.

Intervention Type DIETARY_SUPPLEMENT

Milk, 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.

Intervention Type DIETARY_SUPPLEMENT

EEG_pre

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

Intervention Type DEVICE

EEG_post

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Soremartec Italia S.r.l.

UNKNOWN

Sponsor Role collaborator

Ospedale San Donato

OTHER

Sponsor Role lead

Responsible Party

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Anna Ferrulli

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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San Donato Hospital

San Donato Milanese, MI, Italy

Site Status

Countries

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Italy

References

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Barclay AW, Brand-Miller JC, Wolever TM. Glycemic index, glycemic load, and glycemic response are not the same. Diabetes Care. 2005 Jul;28(7):1839-40. doi: 10.2337/diacare.28.7.1839. No abstract available.

Reference Type BACKGROUND
PMID: 15983358 (View on PubMed)

Franz MJ. The glycemic index: not the most effective nutrition therapy intervention. Diabetes Care. 2003 Aug;26(8):2466-8. doi: 10.2337/diacare.26.8.2466. No abstract available.

Reference Type BACKGROUND
PMID: 12882880 (View on PubMed)

Esposito K, Giugliano D. Low-glycemic load diet and resting energy expenditure. JAMA. 2005 Mar 9;293(10):1189; auhor reply 1189-90. doi: 10.1001/jama.293.10.1189-a. No abstract available.

Reference Type BACKGROUND
PMID: 15755939 (View on PubMed)

Benedini S, Codella R, Caumo A, Marangoni F, Luzi L. Different circulating ghrelin responses to isoglucidic snack food in healthy individuals. Horm Metab Res. 2011 Feb;43(2):135-40. doi: 10.1055/s-0030-1269900. Epub 2011 Jan 10.

Reference Type BACKGROUND
PMID: 21225542 (View on PubMed)

Cummings DE, Purnell JQ, Frayo RS, Schmidova K, Wisse BE, Weigle DS. A preprandial rise in plasma ghrelin levels suggests a role in meal initiation in humans. Diabetes. 2001 Aug;50(8):1714-9. doi: 10.2337/diabetes.50.8.1714.

Reference Type BACKGROUND
PMID: 11473029 (View on PubMed)

Other Identifiers

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Colazioni/4

Identifier Type: -

Identifier Source: org_study_id

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