Clinical trial NCT02897570: 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
Overall status: COMPLETED
Phase: NA
Conditions: Feeding Behaviors
Lack of Satiety
Attention Deficit and Disruptive Behavior Disorders
Keywords: ghrelin
breakfast meal
P-300
Lead sponsor: Ospedale San Donato
Sponsor class: OTHER
Collaborators: name: Soremartec Italia S.r.l.
First posted: 2016-09-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Effect of glucose vs different kind of breakfasts on cognitive performances via brain evoked-potentials measure
timeFrame: The incremental (post-pre) frontal P300 potential was assessed as a "change" ( before and 180 min after consumption)
Secondary outcomes:
measure: Effect of glucose vs different kind of breakfasts on AUC_glycemia in healthy subjects
timeFrame: Blood samples are drawn at -15, 0, 15, 30, 45, 60, 75, 90, 120 minutes with respect to the ingestion.
measure: Effect of glucose vs different kind of breakfasts on AUC_ghrelinemia in healthy subjects.
timeFrame: Blood samples are drawn at -15, 0, 15, 30, 45, 60, 75, 90, 120 minutes with respect to the ingestion.
measure: Effect of glucose vs different kind of breakfasts on AUC_insulinemia in healthy subjects.
timeFrame: Blood samples are drawn at -15, 0, 15, 30, 45, 60, 75, 90, 120 minutes with respect to the ingestion.
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: San Donato Hospital
state: MI
Study officials:
References:
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.
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.
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.
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.
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.