Metabolic and Neurofunctional Responses to Breakfasts

Study Overview
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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.

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

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

Intervention / Treatment
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* 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


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glucose<br>EEG_pre + Oral glucose tolerance test (50-g OGTT) + EEG_post | Dietary Supplement: Glucose<br>* 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.<br>Device: EEG_pre<br>* Electroencephalography (EEG) was performed prior each tolerance test to assess frontal P300-evoked potentials<br>Device: EEG_post<br>* Electroencephalography (EEG) was performed upon completion of each tolerance test to assess frontal P300-evoked potentials<br>|
| Experimental: Milk + Cereals<br>EEG_pre + B1: milk (125ml) and cereals (30g) + EEG_post | Dietary Supplement: Milk & Cereals<br>* 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<br>Dietary Supplement: Milk, apple & snack<br>* 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.<br>Device: EEG_pre<br>* Electroencephalography (EEG) was performed prior each tolerance test to assess frontal P300-evoked potentials<br>Device: EEG_post<br>* Electroencephalography (EEG) was performed upon completion of each tolerance test to assess frontal P300-evoked potentials<br>|
| Experimental: Milk + Apple + Snack<br>EEG_pre + B2: milk (220ml), apple (200g) and cream chocolate filled sponge cake (30g) + EEG_post | Dietary Supplement: Milk & Cereals<br>* 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<br>Dietary Supplement: Milk, apple & bread w/ cream<br>* 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.<br>Device: EEG_pre<br>* Electroencephalography (EEG) was performed prior each tolerance test to assess frontal P300-evoked potentials<br>Device: EEG_post<br>* Electroencephalography (EEG) was performed upon completion of each tolerance test to assess frontal P300-evoked potentials<br>|
| Experimental: Milk + Apple + Bread w/ cream<br>EEG_pre + B3: milk (125ml), apple (150g), and bread (50g) with hazelnut chocolate cream (15g) + EEG_post | Dietary Supplement: Milk & Cereals<br>* 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<br>Dietary Supplement: Milk, apple & bread w/ cream<br>* 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.<br>Device: EEG_pre<br>* Electroencephalography (EEG) was performed prior each tolerance test to assess frontal P300-evoked potentials<br>Device: EEG_post<br>* Electroencephalography (EEG) was performed upon completion of each tolerance test to assess frontal P300-evoked potentials<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of glucose vs different kind of breakfasts on cognitive performances via brain evoked-potentials measure | 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. | The incremental (post-pre) frontal P300 potential was assessed as a change ( before and 180 min after consumption) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of glucose vs different kind of breakfasts on AUC_glycemia in healthy subjects | 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). | Blood samples are drawn at -15, 0, 15, 30, 45, 60, 75, 90, 120 minutes with respect to the ingestion. | 
| Effect of glucose vs different kind of breakfasts on AUC_ghrelinemia in healthy subjects. | 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). | Blood samples are drawn at -15, 0, 15, 30, 45, 60, 75, 90, 120 minutes with respect to the ingestion. | 
| Effect of glucose vs different kind of breakfasts on AUC_insulinemia in healthy subjects. | 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). | Blood samples are drawn at -15, 0, 15, 30, 45, 60, 75, 90, 120 minutes with respect to the ingestion. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ghrelin, breakfast meal, P-300