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临床试验/NCT03358745
NCT03358745已完成不适用

Impact of Meal Order on Postprandial Cardiometabolic Risk Markers

Lund University4 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2016年6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
21
试验地点
4
主要终点
Area under the curve of postprandial glycemia

研究概览

简要总结

The order in which the different components of a meal are eaten may have impact on the postprandial metabolic responses to carbohydrates, fat and proteins. This study will compare blood lipids and glycemia regulation following lunches of identical composition but varying the order of intake of the different meal components.

详细描述

The order in which the different components of a meal are eaten may have impact on the postprandial metabolic responses to carbohydrates, fat and proteins. Some of these responses are associated with the risk for developing cardiometabolic complications.

The study will be carried out in a cohort of healthy subjects with a wide BMI range and normal fasting glycemia. Postprandial metabolic responses to a reference meal starting with bread and butter (BB) will be compared with those registered after 3 other meals of identical composition, in which the starter will be permutated. Each meal is tested on an independent experimental session, with a 1 week washout interval.

The intervention will be carried out at the Food for Health Science Centre - Lund University. Additionally, the plan contemplates an initial information visit including screening of fasting blood glucose. In total, each volunteer completing the study will pay five visits to the clinical unit.

Based on the results from the above-described phase, a second step of the study will compare various quality attributes of the most effective starter on the impact on cardiometabolic risk markers, as a way to optimize putative protective actions and to gain further mechanistic insight.

研究设计

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

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI between 20 and 30 kg/m2
  • Fasting blood glucose ≤ 6.1 mmol/L
  • No known medical condition

排除标准

  • Smoking habits
  • Treatment for high blood pressure
  • Treatment for hypercholesterolemia

研究组 & 干预措施

Standard meal, bread/butter as starter

Experimental

Subjects eat a reference lunch (reference lunch) at 11:30 am, 4 h after a defined light breakfast. The meal contains 38 g fat and 885 kcal and consists of bread and butter, soup, salad and cheese. The participants eat the bread and butter portion within 15 min and the remaining components of the meal are consumed within the following 15 min (total eating time=30 min).

Blood samples are taken before the lunch and every 30 min postprandial for 4 h.

干预措施: Standard meal, bread/butter as starter (Other)

Standard meal with soup as starter

Experimental

Subjects eat a reference lunch (reference lunch) at 11:30 am, 4 h after a defined light breakfast. The meal contains 38 g fat and 885 kcal. The participants eat the soup portion within 15 min and the remaining components of the meal are consumed within the following 15 min (total eating time=30 min).

干预措施: Standard meal with soup as starter (Other)

Standard meal with cheese as starter

Experimental

Subjects eat a reference lunch (reference lunch) at 11:30 am, 4 h after a defined light breakfast. The meal contains 38 g fat and 885 kcal. The participants eat the cheese portion within 15 min and the remaining components of the meal are consumed within the following 15 min (total eating time=30 min).

干预措施: Standard meal with cheese as starter (Other)

Standard meal with salad as starter

Experimental

Subjects eat a reference lunch (reference lunch) at 11:30 am, 4 h after a defined light breakfast. The meal contains 38 g fat and 885 kcal. The participants eat the salad portion within 15 min and the remaining components of the meal are consumed within the following 15 min (total eating time=30 min).

干预措施: Standard meal with salad as starter (Other)

结局指标

主要结局

Area under the curve of postprandial glycemia

时间窗: 4 hours postprandial

Area under the curve of postprandial glycemia (0-4h) after each intervention, compared to the reference meal. Plasma glucose is measured pre-meal and and at various post-meal intervals for up to for 4 hours. AUC is calculated and compared to AUC recorded after the reference meal.

次要结局

  • Area under the curve (AUC) of postprandial triglyceridemia(4 hours postprandial)
  • Area under the curve (AUC) of postprandial insulinemia(4 hours postprandial)
  • Area under the curve (AUC) of postprandial Glucagon-like peptide (GLP-1), Peptide YY (PYY) and glucose-dependent insulinotropic polypeptide (GIP)(4 hours)

研究者

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

Juscelino Tovar

Project Leader

Lund University

研究点 (4)

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