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临床试验/NCT02533986
NCT02533986已完成1 期

Effects of Berry Peel Intake on Glucose Metabolism in Healthy Subjects

Lund University2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
23
试验地点
2
主要终点
Postprandial blood glucose response after acute intervention

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

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

入选标准

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

排除标准

  • 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

结局指标

主要结局

Postprandial blood glucose response after acute intervention

时间窗: -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.

Incremental area under curve (iAUC) blood glucose response after long-term intervention

时间窗: 4 weeks

The capillary blood will be collected for glucose analysis using a glucometer.

次要结局

  • Postprandial subjective appetite rating after acute intervention(-30, 0, 15, 30, 45, 60, 120, and 180 min.)
  • Incremental area under curve (iAUC) of interleukin-6 (IL-6) after long-term intervention(4 weeks)
  • Incremental area under curve (iAUC) of C-reactive protein (CRP) after long-term intervention(4 weeks)
  • Peripheral blood mononuclear cells (PBMCs) inflammatory genes expression after acute intervention(180 min after challenge meal.)
  • Postprandial interleukin-6 (IL-6) after acute intervention(-30, 60, 120, and 180 min.)
  • Postprandial adiponectin after acute intervention(-30, 0, 60, 120, and 180 min.)
  • Postprandial selective attention after long-term intervention(45, 90, and 180 min after challenge meal.)
  • Postprandial serum insulin response after acute intervention(-30, 0, 15, 30, 45, 60, 120, and 180 min.)
  • Incremental area under curve (iAUC) serum insulin response after long-term intervention(4 weeks)
  • Incremental area under curve (iAUC) subjective appetite rating after long-term intervention(4 weeks)
  • Postprandial C-reactive protein (CRP) after acute intervention(-30, 60, 120, and 180 min.)
  • Postprandial adiponectin after long-term intervention with berry peel(4 weeks)
  • Peripheral blood mononuclear cells (PBMCs) inflammatory genes expression after long-term intervention(-30 min. (Day-28 control); 180 min. (Day-28 control); -30 min. (Day-28 berry); 180 min. (Day-28 berry))

研究者

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

Elin Östman

Assoc. Prof., PhD

Lund University

研究点 (2)

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