Clinical Trial: Metabolic and Neurofunctional Responses to Breakfasts

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.


Detailed Summary:
Sponsor: Ospedale San Donato

Current Primary Outcome: Effect of glucose vs different kind of breakfasts on cognitive performances via brain evoked-potentials measure [ Time Frame: The incremental (post-pre) frontal P300 potential was assessed as a "change" ( before and 180 min after consumption) ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Effect of glucose vs different kind of breakfasts on AUC_glycemia in healthy subjects [ Time Frame: Blood samples are drawn at -15, 0, 15, 30, 45, 60, 75, 90, 120 minutes with respect to the ingestion. ]
    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. [ Time Frame: Blood samples are drawn at -15, 0, 15, 30, 45, 60, 75, 90, 120 minutes with respect to the ingestion. ]
    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. [ Time Frame: Blood samples are drawn at -15, 0, 15, 30, 45, 60, 75, 90, 120 minutes with respect to the ingestion. ]
    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).


Original Secondary Outcome: Same as current

Information By: Ospedale San Donato

Dates:
Date Received: August 26, 2016
Date Started: October 2013
Date Completion:
Last Updated: September 13, 2016
Last Verified: September 2016