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Completed

NCT Number: NCT02897570

Metabolic and Neurofunctional Responses to Breakfasts

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.

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Key information

Conditions

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

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Donato Hospital

San Donato Milanese, MI, 20097, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucose

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.

Milk & Cereals

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

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.

Milk, apple & bread w/ cream

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

Device

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

EEG_post

Device

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

Primary outcomes

  1. Effect of glucose vs different kind of breakfasts on cognitive performances via brain evoked-potentials measure

    Time frame: 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 outcomes

  1. Effect of glucose vs different kind of breakfasts on AUC_glycemia in healthy subjects

    Time frame: 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).

  2. Effect of glucose vs different kind of breakfasts on AUC_ghrelinemia in healthy subjects.

    Time frame: 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).

  3. Effect of glucose vs different kind of breakfasts on AUC_insulinemia in healthy subjects.

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Ospedale San Donato

Other

Collaborators

  • Soremartec Italia S.r.l.

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 13, 2016
Registry last updated
Sep 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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