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临床试验/NCT02897570
NCT02897570已完成不适用

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

Ospedale San Donato1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2013年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
Effect of glucose vs different kind of breakfasts on cognitive performances via brain evoked-potentials measure

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

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

研究组 & 干预措施

Glucose

Active Comparator

EEG_pre + Oral glucose tolerance test (50-g OGTT) + EEG_post

干预措施: EEG_pre (Device)

Glucose

Active Comparator

EEG_pre + Oral glucose tolerance test (50-g OGTT) + EEG_post

干预措施: EEG_post (Device)

Milk + Cereals

Experimental

EEG_pre + B1: milk (125ml) and cereals (30g) + EEG_post

干预措施: Milk & Cereals (Dietary Supplement)

Milk + Cereals

Experimental

EEG_pre + B1: milk (125ml) and cereals (30g) + EEG_post

干预措施: Milk, apple & snack (Dietary Supplement)

Milk + Cereals

Experimental

EEG_pre + B1: milk (125ml) and cereals (30g) + EEG_post

干预措施: EEG_pre (Device)

Milk + Cereals

Experimental

EEG_pre + B1: milk (125ml) and cereals (30g) + EEG_post

干预措施: EEG_post (Device)

Milk + Apple + Snack

Experimental

EEG_pre + B2: milk (220ml), apple (200g) and cream chocolate filled sponge cake (30g) + EEG_post

干预措施: Milk & Cereals (Dietary Supplement)

Milk + Apple + Snack

Experimental

EEG_pre + B2: milk (220ml), apple (200g) and cream chocolate filled sponge cake (30g) + EEG_post

干预措施: Milk, apple & bread w/ cream (Dietary Supplement)

Milk + Apple + Snack

Experimental

EEG_pre + B2: milk (220ml), apple (200g) and cream chocolate filled sponge cake (30g) + EEG_post

干预措施: EEG_pre (Device)

Milk + Apple + Snack

Experimental

EEG_pre + B2: milk (220ml), apple (200g) and cream chocolate filled sponge cake (30g) + EEG_post

干预措施: EEG_post (Device)

Milk + Apple + Bread w/ cream

Experimental

EEG_pre + B3: milk (125ml), apple (150g), and bread (50g) with hazelnut chocolate cream (15g) + EEG_post

干预措施: Milk & Cereals (Dietary Supplement)

Milk + Apple + Bread w/ cream

Experimental

EEG_pre + B3: milk (125ml), apple (150g), and bread (50g) with hazelnut chocolate cream (15g) + EEG_post

干预措施: Milk, apple & bread w/ cream (Dietary Supplement)

Milk + Apple + Bread w/ cream

Experimental

EEG_pre + B3: milk (125ml), apple (150g), and bread (50g) with hazelnut chocolate cream (15g) + EEG_post

干预措施: EEG_pre (Device)

Milk + Apple + Bread w/ cream

Experimental

EEG_pre + B3: milk (125ml), apple (150g), and bread (50g) with hazelnut chocolate cream (15g) + EEG_post

干预措施: EEG_post (Device)

Glucose

Active Comparator

EEG_pre + Oral glucose tolerance test (50-g OGTT) + EEG_post

干预措施: Glucose (Dietary Supplement)

结局指标

主要结局

Effect of glucose vs different kind of breakfasts on cognitive performances via brain evoked-potentials measure

时间窗: 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.

次要结局

  • 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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Ferrulli

MD

Ospedale San Donato

研究点 (1)

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