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Effects of Berry Peel Intake on Glucose Metabolism in Healthy Subjects

2016年2月10日 更新者：Elin Östman、Lund University
The main objective of this study is to investigate the effect of a 4-weeks intake of berry peel powder on fasting and postprandial glucose metabolism and inflammatory markers. The berry peel product will be compared with a placebo in a single-blind, cross-over design. Furthermore, inflammation-related peripheral blood mononuclear cells (PBMCs) genes expression, appetite and cognitive performance will be included as a pilot study. Investigators hypothesize that long-term consumption of polyphenols and fibres of berry peel will exhibit both direct and indirect actions in healthy overweight subjects by improvement of glucose-associated markers as well as ameliorating inflammation. Moreover, above metabolic markers will correlated with improvements in inflammation-related PBMCs genes expression, subjective appetite and cognitive performance after long-term consumption of berry peel as a source of polyphenols.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

23

阶段

  • 阶段2
  • 阶段1

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

  • 瑞典
    • Skåne
      • Lund、Skåne、瑞典、221 00
        • Food for Health Science Centre (Medicon Village) - Lund University

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

18年 至 40年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Healthy males and females
  • Signed informed consent
  • BMI 25-30 kg/m2
  • Must be able to accept plant-based foods/drinks

Exclusion Criteria:

  • Below 18 years or above 40 years
  • Smoking or using snuff
  • vegetarian or vegan
  • Stressed by venous blood sampling or previous experience of being difficult canulation

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：基础科学
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：Control drink
Dietary supplement: Control drink As control, subjects are asked to consume 150 ml control drink containing equal amount of insoluble fiber (cellulose) and sugar for 28 days. In addition, on days-1 and 28, subjects will receive an acute challenge of placebo drink at our clinical facility. After 30 min. control drink intake, subjects will be given standardized breakfast corresponding to 50 g available carbohydrates.
膳食补充剂：控制饮料
实验性的：Berry peel drink
Dietary supplement: Berry peel drink Subjects are asked to consume 150 ml experimental drink containing a berry peel fruit powder. In addition, on days-1 and 28, subjects will receive an acute challenge of test drink at our clinical facility. After 30 min. berry drink intake, subjects will be given standardized breakfast corresponding to 50 g available carbohydrates.
膳食补充剂：Berry peel drink

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
Postprandial blood glucose response after acute intervention
大体时间：-30, 0, 15, 30, 45, 60, 120, and 180 min after challenge meal.
The capillary blood will be collected for glucose analysis using a glucometer.
-30, 0, 15, 30, 45, 60, 120, and 180 min after challenge meal.
Incremental area under curve (iAUC) blood glucose response after long-term intervention
大体时间：4 weeks
The capillary blood will be collected for glucose analysis using a glucometer.
4 weeks

次要结果测量

结果测量
措施说明
大体时间
Postprandial serum insulin response after acute intervention
大体时间：-30, 0, 15, 30, 45, 60, 120, and 180 min.
The capillary blood will be collected for insulin analysis using commercial ELISA kits
-30, 0, 15, 30, 45, 60, 120, and 180 min.
Incremental area under curve (iAUC) serum insulin response after long-term intervention
大体时间：4 weeks
The capillary blood will be collected for insulin analysis using commercial ELISA kits
4 weeks
Postprandial subjective appetite rating after acute intervention
大体时间：-30, 0, 15, 30, 45, 60, 120, and 180 min.
Appetite will be assessed using standard subjective 100mm visual analogue scaled (VAS).
-30, 0, 15, 30, 45, 60, 120, and 180 min.
Incremental area under curve (iAUC) subjective appetite rating after long-term intervention
大体时间：4 weeks
Appetite will be assessed using standard subjective 100mm visual analogue scaled (VAS).
4 weeks
Postprandial C-reactive protein (CRP) after acute intervention
大体时间：-30, 60, 120, and 180 min.
The venous blood will be collected for CRP analysis using ELISA commercial kits
-30, 60, 120, and 180 min.
Incremental area under curve (iAUC) of C-reactive protein (CRP) after long-term intervention
大体时间：4 weeks
The venous blood will be collected for inflammatory analysis using ELISA commercial kits
4 weeks
Postprandial adiponectin after acute intervention
大体时间：-30, 0, 60, 120, and 180 min.
The venous blood will be collected for adiponectin analysis using ELISA commercial kits
-30, 0, 60, 120, and 180 min.
Postprandial adiponectin after long-term intervention with berry peel
大体时间：4 weeks
The venous blood will be collected for adiponectin analysis using ELISA commercial kits
4 weeks
Peripheral blood mononuclear cells (PBMCs) inflammatory genes expression after acute intervention
大体时间：180 min after challenge meal.
The venous blood samples will be taken for isolation of peripheral blood mononuclear cells (PBMCs). Extracted total RNA will then be used for running quantitative-PCR.
180 min after challenge meal.
Peripheral blood mononuclear cells (PBMCs) inflammatory genes expression after long-term intervention
大体时间：-30 min. (Day-28 control); 180 min. (Day-28 control); -30 min. (Day-28 berry); 180 min. (Day-28 berry)
The venous blood samples will be taken for isolation of peripheral blood mononuclear cells (PBMCs). Extracted total RNA will then be used for running quantitative-PCR.
-30 min. (Day-28 control); 180 min. (Day-28 control); -30 min. (Day-28 berry); 180 min. (Day-28 berry)
Postprandial selective attention after long-term intervention
大体时间：45, 90, and 180 min after challenge meal.
The selective attention will be assessed using a standardized software (Röd and Grön software) that measures wrong/right decisions and time of reaction when the subjects is faced with a challenging stimulus.
45, 90, and 180 min after challenge meal.
Postprandial interleukin-6 (IL-6) after acute intervention
大体时间：-30, 60, 120, and 180 min.
The venous blood will be collected for IL-6 analysis using ELISA commercial kits
-30, 60, 120, and 180 min.
Incremental area under curve (iAUC) of interleukin-6 (IL-6) after long-term intervention
大体时间：4 weeks
The venous blood will be collected for IL-6 analysis using ELISA commercial kits
4 weeks

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。

赞助

Lund University

合作者

University of Campinas, Brazil
Conselho Nacional de Desenvolvimento Científico e Tecnológico

调查人员

  • 学习椅：Yoghatama Cindya Zanzer, MSc、Lund University
  • 学习椅：Angela G Batista, MSc、Lund University; University of Campinas

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

2015年8月1日

初级完成 (实际的)

2015年12月1日

研究完成 (实际的)

2016年1月1日

研究注册日期

首次提交

2015年8月20日

首先提交符合 QC 标准的

2015年8月24日

首次发布 (估计)

2015年8月27日

研究记录更新

最后更新发布 (估计)

2016年2月11日

上次提交的符合 QC 标准的更新

2016年2月10日

最后验证

2016年2月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • COGBERRY-BR

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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