Metabolic and Neurofunctional Responses to Breakfasts

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • MI
    • San Donato Milanese, MI, Italy, 20097
      • San Donato Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Ospedale San Donato
• Collaborators: Soremartec Italia S.r.l.

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: August 26, 2016
• First Submitted That Met QC Criteria: September 12, 2016
• First Posted (Estimate): September 13, 2016

Study Record Updates

• Last Update Posted (Estimate): September 14, 2016
• Last Update Submitted That Met QC Criteria: September 13, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: ghrelin; breakfast meal; P-300
• Additional Relevant MeSH Terms: Behavioral Symptoms; Neurodevelopmental Disorders; Problem Behavior; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders
• Other Study ID Numbers: Colazioni/4