NCT02897570

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
Last Updated

September 14, 2016

Status Verified

September 1, 2016

Enrollment Period

1.2 years

First QC Date

August 26, 2016

Last Update Submit

September 13, 2016

Conditions

Feeding BehaviorsLack of SatietyAttention Deficit and Disruptive Behavior Disorders

Keywords

ghrelinbreakfast mealP-300

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Effect of glucose vs different kind of breakfasts on AUC_glycemia in healthy subjects

    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.

    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.

    Blood samples are drawn at -15, 0, 15, 30, 45, 60, 75, 90, 120 minutes with respect to the ingestion.

Study Arms (4)

Glucose

ACTIVE COMPARATOR

EEG\_pre + Oral glucose tolerance test (50-g OGTT) + EEG\_post

Dietary Supplement: GlucoseDevice: EEG_preDevice: EEG_post

Milk + Cereals

EXPERIMENTAL

EEG\_pre + B1: milk (125ml) and cereals (30g) + EEG\_post

Dietary Supplement: Milk & CerealsDietary Supplement: Milk, apple & snackDevice: EEG_preDevice: EEG_post

Milk + Apple + Snack

EXPERIMENTAL

EEG\_pre + B2: milk (220ml), apple (200g) and cream chocolate filled sponge cake (30g) + EEG\_post

Dietary Supplement: Milk & CerealsDietary Supplement: Milk, apple & bread w/ creamDevice: EEG_preDevice: EEG_post

Milk + Apple + Bread w/ cream

EXPERIMENTAL

EEG\_pre + B3: milk (125ml), apple (150g), and bread (50g) with hazelnut chocolate cream (15g) + EEG\_post

Dietary Supplement: Milk & CerealsDietary Supplement: Milk, apple & bread w/ creamDevice: EEG_preDevice: EEG_post

Interventions

GlucoseDIETARY_SUPPLEMENT

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.

Glucose
Milk & CerealsDIETARY_SUPPLEMENT

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 + Bread w/ creamMilk + Apple + SnackMilk + Cereals
Milk, apple & snackDIETARY_SUPPLEMENT

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 + Cereals
Milk, apple & bread w/ creamDIETARY_SUPPLEMENT

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.

Milk + Apple + Bread w/ creamMilk + Apple + Snack
EEG_preDEVICE

Electroencephalography (EEG) was performed prior each tolerance test to assess frontal P300-evoked potentials

GlucoseMilk + Apple + Bread w/ creamMilk + Apple + SnackMilk + Cereals
EEG_postDEVICE

Electroencephalography (EEG) was performed upon completion of each tolerance test to assess frontal P300-evoked potentials

GlucoseMilk + Apple + Bread w/ creamMilk + Apple + SnackMilk + Cereals

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 18.5 - 24.9 kg/m2
  • normal glucose tolerance
  • stable diet

You may not qualify if:

  • type 1 and type 2 diabetes
  • impaired glucose tolerance
  • dyslipidemia
  • metabolic syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Donato Hospital

San Donato Milanese, MI, 20097, Italy

Location

Related 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. doi: 10.2337/diacare.28.7.1839. No abstract available.

    PMID: 15983358BACKGROUND

  • 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.

    PMID: 12882880BACKGROUND

  • 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.

    PMID: 15755939BACKGROUND

  • 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.

    PMID: 21225542BACKGROUND

  • 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.

    PMID: 11473029BACKGROUND

MeSH Terms

Conditions

Feeding BehaviorAttention Deficit and Disruptive Behavior Disorders

Interventions

GlucoseMilkEdible GrainSnacks

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and BeveragesCrops, AgriculturalSeedsMeals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 26, 2016

First Posted

September 13, 2016

Study Start

October 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

September 14, 2016

Record last verified: 2016-09

Locations

IT(1)