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Feeding BehaviorsNCT02897570

Metabolic and Neurofunctional Responses to Breakfasts

A study testing Glucose, Milk & Cereals and Milk, apple & snack in people with Feeding Behaviors and Lack of Satiety, run by Ospedale San Donato at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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)… Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
What is being tested?
Glucose, Milk & Cereals and Milk, apple & snack
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteItaly
Study dates
Oct 2013to Dec 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • San Donato Hospital

    San Donato Milanese, MI, 20097

Other trials in Italy

About this study

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

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.

Being tested
Glucose, Milk & Cereals, Milk, apple & snack, Milk, apple & bread w/ cream, EEG_pre
Keywords
ghrelin, breakfast meal, P-300
Medical subject headings
Feeding Behavior, Attention Deficit and Disruptive Behavior Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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 & 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, 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.

  • EEG_preDevice

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

  • EEG_postDevice

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

Study groups in NCT02897570
Study groupRoleWhat they receive
GlucoseActive comparatorEEG_pre + Oral glucose tolerance test (50-g OGTT) + EEG_post
Receives: Dietary Supplement: Glucose; Device: EEG_pre; Device: EEG_post
Milk + CerealsExperimentalEEG_pre + B1: milk (125ml) and cereals (30g) + EEG_post
Receives: Dietary Supplement: Milk & Cereals; Dietary Supplement: Milk, apple & snack; Device: EEG_pre; Device: EEG_post
Milk + Apple + SnackExperimentalEEG_pre + B2: milk (220ml), apple (200g) and cream chocolate filled sponge cake (30g) + EEG_post
Receives: Dietary Supplement: Milk & Cereals; Dietary Supplement: Milk, apple & bread w/ cream; Device: EEG_pre; Device: EEG_post
Milk + Apple + Bread w/ creamExperimentalEEG_pre + B3: milk (125ml), apple (150g), and bread (50g) with hazelnut chocolate cream (15g) + EEG_post
Receives: Dietary Supplement: Milk & Cereals; Dietary Supplement: Milk, apple & bread w/ cream; Device: EEG_pre; Device: EEG_post

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: The incremental (post-pre) frontal P300 potential was assessed as a "change" ( before and 180 min after consumption)

Secondary outcomes (3)

  1. 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).

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

  2. 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).

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

  3. 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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2016 (estimated)
  2. Study startOct 2013
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02897570
Sponsor's protocol ID
Colazioni/4
Status last verified
Sep 2016
First submitted
26 Aug 2016
Last updated
14 Sep 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 15983358

  • 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.

    PubMed 12882880

  • 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.

    PubMed 15755939

  • 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.

    PubMed 21225542

  • 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.

    PubMed 11473029

Questions about this trial

What is this clinical trial studying?

A study testing Glucose, Milk & Cereals and Milk, apple & snack in people with Feeding Behaviors and Lack of Satiety, run by Ospedale San Donato at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02897570, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2016; AzTrials last refreshed its copy on 1 Nov 2026.

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