Metabolic and Neurofunctional Responses to Breakfasts

Attention Deficit and Disruptive Behavior Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02897570
• Other study ID #: Colazioni/4
• Status: Completed
• Phase: N/A
• First received: August 26, 2016
• Last updated: September 13, 2016
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: September 2016
• Source: Ospedale San Donato
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Attention Deficit and Disruptive Behavior Disorders
• Attention Deficit Disorder with Hyperactivity
• Feeding Behaviors
• Lack of Satiety
• Mental Disorders
• Problem Behavior

Intervention

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.
• 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
• 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.
• 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.

Device:
• EEG_pre
Electroencephalography (EEG) was performed prior each tolerance test to assess frontal P300-evoked potentials
• EEG_post
Electroencephalography (EEG) was performed upon completion of each tolerance test to assess frontal P300-evoked potentials

Locations

Country	Name	City	State
Italy	San Donato Hospital	San Donato Milanese	MI

Sponsors (2)

Lead Sponsor	Collaborator
Ospedale San Donato	Soremartec Italia S.r.l.

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

Esposito K, Giugliano D. Low-glycemic load diet and resting energy expenditure. JAMA. 2005 Mar 9;293(10):1189; auhor reply 1189-90. — View Citation

Franz MJ. The glycemic index: not the most effective nutrition therapy intervention. Diabetes Care. 2003 Aug;26(8):2466-8. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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.	Yes
Secondary	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.	Yes
Secondary	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.	Yes