Metabolic and Neurofunctional Responses to Breakfasts
Primary Purpose
Feeding Behaviors, Lack of Satiety, Attention Deficit and Disruptive Behavior Disorders
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Glucose
Milk & Cereals
Milk, apple & snack
Milk, apple & bread w/ cream
EEG_pre
EEG_post
Sponsored by
About this trial
This is an interventional health services research trial for Feeding Behaviors focused on measuring ghrelin, breakfast meal, P-300
Eligibility Criteria
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
Sites / Locations
- San Donato Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
Glucose
Milk + Cereals
Milk + Apple + Snack
Milk + Apple + Bread w/ cream
Arm Description
EEG_pre + Oral glucose tolerance test (50-g OGTT) + EEG_post
EEG_pre + B1: milk (125ml) and cereals (30g) + EEG_post
EEG_pre + B2: milk (220ml), apple (200g) and cream chocolate filled sponge cake (30g) + EEG_post
EEG_pre + B3: milk (125ml), apple (150g), and bread (50g) with hazelnut chocolate cream (15g) + EEG_post
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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).
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).
Full Information
NCT ID
NCT02897570
First Posted
August 26, 2016
Last Updated
September 13, 2016
Sponsor
Ospedale San Donato
Collaborators
Soremartec Italia S.r.l.
1. Study Identification
Unique Protocol Identification Number
NCT02897570
Brief Title
Metabolic and Neurofunctional Responses to Breakfasts
Official Title
Effect of Glucose Versus Mixed Breakfast on Metabolic and Neurofunctional Responses in Healthy Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale San Donato
Collaborators
Soremartec Italia S.r.l.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feeding Behaviors, Lack of Satiety, Attention Deficit and Disruptive Behavior Disorders
Keywords
ghrelin, breakfast meal, P-300
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glucose
Arm Type
Active Comparator
Arm Description
EEG_pre + Oral glucose tolerance test (50-g OGTT) + EEG_post
Arm Title
Milk + Cereals
Arm Type
Experimental
Arm Description
EEG_pre + B1: milk (125ml) and cereals (30g) + EEG_post
Arm Title
Milk + Apple + Snack
Arm Type
Experimental
Arm Description
EEG_pre + B2: milk (220ml), apple (200g) and cream chocolate filled sponge cake (30g) + EEG_post
Arm Title
Milk + Apple + Bread w/ cream
Arm Type
Experimental
Arm Description
EEG_pre + B3: milk (125ml), apple (150g), and bread (50g) with hazelnut chocolate cream (15g) + EEG_post
Intervention Type
Dietary Supplement
Intervention Name(s)
Glucose
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Milk & Cereals
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Milk, apple & snack
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Milk, apple & bread w/ cream
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
EEG_pre
Intervention Description
Electroencephalography (EEG) was performed prior each tolerance test to assess frontal P300-evoked potentials
Intervention Type
Device
Intervention Name(s)
EEG_post
Intervention Description
Electroencephalography (EEG) was performed upon completion of each tolerance test to assess frontal P300-evoked potentials
Primary Outcome Measure Information:
Title
Effect of glucose vs different kind of breakfasts on cognitive performances via brain evoked-potentials measure
Description
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.
Time Frame
The incremental (post-pre) frontal P300 potential was assessed as a "change" ( before and 180 min after consumption)
Secondary Outcome Measure Information:
Title
Effect of glucose vs different kind of breakfasts on AUC_glycemia in healthy subjects
Description
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).
Time Frame
Blood samples are drawn at -15, 0, 15, 30, 45, 60, 75, 90, 120 minutes with respect to the ingestion.
Title
Effect of glucose vs different kind of breakfasts on AUC_ghrelinemia in healthy subjects.
Description
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).
Time Frame
Blood samples are drawn at -15, 0, 15, 30, 45, 60, 75, 90, 120 minutes with respect to the ingestion.
Title
Effect of glucose vs different kind of breakfasts on AUC_insulinemia in healthy subjects.
Description
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).
Time Frame
Blood samples are drawn at -15, 0, 15, 30, 45, 60, 75, 90, 120 minutes with respect to the ingestion.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
San Donato Hospital
City
San Donato Milanese
State/Province
MI
ZIP/Postal Code
20097
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
15983358
Citation
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.
Results Reference
background
PubMed Identifier
12882880
Citation
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.
Results Reference
background
PubMed Identifier
15755939
Citation
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.
Results Reference
background
PubMed Identifier
21225542
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.
Results Reference
background
PubMed Identifier
11473029
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. doi: 10.2337/diabetes.50.8.1714.
Results Reference
background
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Metabolic and Neurofunctional Responses to Breakfasts
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