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临床试验/NCT02867215
NCT02867215已完成不适用

Whole Barley Bread: Effect on the Risk of Metabolic Disease and Other Health Effects

University of Copenhagen0 个研究点目标入组 14 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
主要终点
LDL-c levels evaluated by analysis of fasting blood samples

研究概览

简要总结

The aim of this study was to compare the metabolic effects of consuming whole barley bread and whole wheat bread, in healthy subjects. Also, to investigate the effect of whole grain flour on mineral status.

详细描述

Generally, diet can be improved in order to lower diet-related diseases risk. However, the increasing prevalence rates of diet-related diseases indicate that, in practice, people's diet does not follow the recommendations. The intake of whole flour foods is consistently associated with reduced risk of type 2 diabetes and cardiovascular diseases in epidemiological studies, although the mechanisms of this association are unclear. Here the aim is to compare the metabolic effects and mineral status of consumption of diet containing wholemeal barley bread versus whole meal wheat bread in healthy subjects.

The intervention was designed as a randomized, cross over trial of 3-weeks duration. A total of 14 participants was included in the study. In one period subjects received WBB bread; in the second period, subjects received WWB bread. This bread is based on the recipe of Egyptian Baladi bread but formed in Danish buns form. Participants incorporated this bread into their normal habitual diet with regard to the study restrictions about other cereal food products. At the beginning and end of each intervention period blood was drawn and urine collected and stored for later analysis.

The primary outcomes of this study are evaluation of LDL-c, insulin and glucose levels evaluated by analysis of fasting blood samples. Furthermore, selected measures to evaluate SCFA level in blood is to be evaluated. Secondary outcomes include mineral status.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 53 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Like and tolerate wheat/ barley bread products.
  • Age: 20 - 53 years
  • Body mass index (BMI): 23 - 30 kg/m2
  • Weight stable (<3 kg weight change during the last 6 months)
  • Apparently healthy
  • Informed consent signed
  • Freezer capacity for 1 week bread provision
  • Can attend all visits required for the study

排除标准

  • Wheat/gluten or barley intolerance
  • Smoking on a daily basis
  • Lactating (or lactating within 6 weeks prior to study start), pregnant (or pregnant within 3 months prior to study start) or wish to become pregnant during the study
  • Diagnosed with any form of diabetes or cardiovascular disease
  • Reported chronic gastrointestinal disorders
  • Taking dietary supplements during or one month prior to the study
  • Lack of cooperation and adherence to the protocol
  • Use of prescription medication will be evaluated on an individual basis
  • Blood donation within 3 months prior to study start or during the study
  • Participation in other clinical trials

结局指标

主要结局

LDL-c levels evaluated by analysis of fasting blood samples

时间窗: 8-9 weeks

Evaluated by analysis of fasting blood samples

Insulin levels evaluated by analysis of fasting blood samples

时间窗: 8-9 weeks

Evaluated by analysis of fasting blood samples

Glucose levels evaluated by analysis of fasting blood samples

时间窗: 8-9 weeks

Evaluated by analysis of fasting blood samples

次要结局

  • Mineral status(8-9 weeks)

研究者

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

Arne Astrup

Professor

University of Copenhagen

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