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Metabolic and Neurofunctional Responses to Breakfasts

S

San Donato Group (GSD)

Status

Completed

Conditions

Attention Deficit and Disruptive Behavior Disorders
Lack of Satiety
Feeding Behaviors

Treatments

Dietary Supplement: Milk, apple & bread w/ cream
Dietary Supplement: Milk & Cereals
Dietary Supplement: Glucose
Device: EEG_pre
Device: EEG_post
Dietary Supplement: Milk, apple & snack

Study type

Interventional

Funder types

Other

Identifiers

NCT02897570
Colazioni/4

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

12 participants in 4 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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