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Effects on Cognitive Functions and Mood of Food Products Rich in Polyphenols

2017年9月6日 更新者:Anne Nilsson、Lund University

Food Design for Improved Cognitive Performance/Effects on Cognitive Functions and Mood of Food Products Rich in Polyphenols

The purpose of this study is to investigate effects of a selected food product rich in polyphenol on cognitive performance and mood.

研究概览

详细说明

The metabolic syndrome (MetS) includes a cluster of dysfunctions that identifies subjects at risk of developing type-2 diabetes and cardiovascular disease (CVD). A key feature appears to be chronic increased inflammation and activation of the innate system. Consequently, increased low-grade inflammation has been connected to adverse effects on insulin sensitivity, glucose- and lipid metabolism, and blood pressure, and circulating markers of inflammation such as IL-6. A growing body of evidence also link low-grade inflammation to poorer cognitive functioning. Type 2 diabetes, MetS, and glucose intolerance are increasingly being associated with impaired cognition.

Dietary patterns which promote sub-clinical inflammation are increasingly being considered predictive of future risk of CVD and type-2 diabetes. Epidemiological data shows that a high consumption of vegetables and fruits is associated with a lowered risk of cancer and cardiovascular disease, which may be due to the high concentrations of polyphenols or other anti-oxidants that are found in such foods.

In the presently described project it is hypothesized that four weeks daily consumption of a product specific high in flavanols can improve metabolic risk variables and cognitive functions in healthy subjects.

The purpose is therefore to investigate effects of flavanols on cognitive functions and cardiometabolic risk, and to investigate relations between cardiometabolic risk markers and cognitive performance. The test product is a commonly used food product, known to be specifically rich in flavanols. The effects of the test product is compared with effects of a control product that is based on a similar food product but is lacking flavanols.

Test parameters:

Cognitive tests: Working memory tests (an oral test), selection attention test (measure also reaction time, a computerized test ), and stroop test (a computerized test.

Mood is determined for 6 different mood sensations using VAS scales.

Bio markers in blood: glucose regulation (glucose, insulin), markers of inflammation and oxidative stress (IL-6, MDA, oxLDL), blood lipids (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides), vascular function (P-Selectin, PAI-1, NO), gut hormones involved in metabolism and satiety (PYY, GLP-1) gut hormon involved in mucosa integrity (GLP-2), markers of brain function (BDNF, neurotensin).

Blood pressure.

研究类型

介入性

注册 (实际的)

38

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Lund、瑞典、223 81
        • Lund Univercity, Medicon village, Functional Food Science Centre

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年 至 70年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Healthy women and men
  • Between 50-70 years
  • BMI 19-25

Exclusion Criteria:

  • Metabolic diseases
  • Food allergies
  • Smoker

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Flavanol rich food product
A portion of a common flavanol rich food product is consumed daily for 4 weeks
polyphenol rich test product
安慰剂比较:Non-flavanol food product
A portion of a product similar to the experimental Product, but instead contains low amounts of flavanol, is consumed Daily for 4 weeks as a control.
polyphenol rich test product

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
working memory (WM) capacity
大体时间:Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, working memory capacity is determined four times in the postprandial phase up to 3.5h after breakfast.
The test food product or control is consumed fasting, and after 30 min a standardised breakfast is served. WM tests are performed at 60 min, 120 min, 165 min and 210 min after commencing the intake of test Product. One test takes approximately 8 min to carry out.
Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, working memory capacity is determined four times in the postprandial phase up to 3.5h after breakfast.

次要结果测量

结果测量
措施说明
大体时间
mood assessment
大体时间:Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, subjects registered mood sensations at fasting and five times in the postprandial phase up to 3,5h after breakfast.

Self-reported sensations of mood and feelings of activation was assessed with a modified bipolar variant of the Swedish Core Affect Scales (SCAS) comprising six rating scales of two orthogonal dimensions of core affect: valence (unpleasantness-pleasantness) and activation (quietness-excitement).

Mood scales are filled out at fasting, prior to the standardised breakfast served after 30 min and directly after cognitive tests started at 60 min, 120 min, 165 min and 210 min after commencing the intake of test product.

Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, subjects registered mood sensations at fasting and five times in the postprandial phase up to 3,5h after breakfast.

其他结果措施

结果测量
措施说明
大体时间
blood pressure
大体时间:Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, blood pressure is determined at fasting and four times in the postprandial phase up to 3,5h after breakfast.
Blood pressure is determined at fasting and at 60 min, 90 min, 150 min and 180 min, prior to other test variables collected at the same test Point.
Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, blood pressure is determined at fasting and four times in the postprandial phase up to 3,5h after breakfast.
glucose regulation
大体时间:Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, blood glucose is determined fasting and then eight times in the postprandial phase up to 3.5h after the standardised breakfast
Blood glucose concentrations (determined in capillary blood), and insulin (determined in venous blood). Blood tests are collected repeatedly during 3h after a standardised breakfast consumed 30 min after commencing the test product/Control Product.
Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, blood glucose is determined fasting and then eight times in the postprandial phase up to 3.5h after the standardised breakfast
selective attention (SA)
大体时间:Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, selective attention is determined three times in the postprandial phase up to 3.5h after the standardised breakfast
Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, selective attention is determined three times in the postprandial phase up to 3.5h after the standardised breakfast
Vascular function
大体时间:Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, vascular marker is determined fasting and up to 3.5h after the standardised breakfast
Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, vascular marker is determined fasting and up to 3.5h after the standardised breakfast
Blood lipids
大体时间:Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, blood lipids are determined fasting and up to 3.5h after the standardised breakfast
Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, blood lipids are determined fasting and up to 3.5h after the standardised breakfast
Marker of inflammation
大体时间:Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, inflammatory markers in blood are determined fasting and up to 3.5h after the standardised breakfast
Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, inflammatory markers in blood are determined fasting and up to 3.5h after the standardised breakfast
Markers of oxidative stress
大体时间:Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, markers of oxidative stress are determined in blood at fasting and then up to 3.5h after a standised breakfast
Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, markers of oxidative stress are determined in blood at fasting and then up to 3.5h after a standised breakfast
Gut peptides
大体时间:Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, gut peptides are determined in blood at fasting
Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, gut peptides are determined in blood at fasting
markers of brain function
大体时间:Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, markers of brain finction are determined in blood at fasting
Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, markers of brain finction are determined in blood at fasting
Stroop test
大体时间:Each of the two intervention periods is 4 weeks. At the first and last day Stroop tests are performed three times after a standardised breakfast up to 3,5h .
Each of the two intervention periods is 4 weeks. At the first and last day Stroop tests are performed three times after a standardised breakfast up to 3,5h .

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年1月1日

初级完成 (实际的)

2015年3月1日

研究完成 (实际的)

2015年3月1日

研究注册日期

首次提交

2014年9月10日

首先提交符合 QC 标准的

2014年9月17日

首次发布 (估计)

2014年9月18日

研究记录更新

最后更新发布 (实际的)

2017年9月8日

上次提交的符合 QC 标准的更新

2017年9月6日

最后验证

2017年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • AFC-2013/619

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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