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Health Effect of Canola Oil Consumption in Shift Workers

2019年6月6日 更新者：Agnieszka Kuleta-Koberska、Poznan University of Life Sciences

The Effect of Canola Oil Consumption on the Selected Cardiometabolic Parameters in a Group of Shift Workers

Shift work is associated with a higher risk of the development of cardiometabolic syndrome (CMtS) than in people working only during the day. One of the factors predisposing to the development of the CMtS in shift workers is an inappropriate composition of their diet. It was observed that the shift workers diet is characterized by a higher intake of saturated fatty acids (SFA) and a lower consumption of unsaturated fatty acids. One potential way to reduce the risk of CMtS in this study group seems to be a modification of their everyday diet by excluding the products of animal origin (e.g. butter) with simultaneously including vegetable oils (i.e. canola oil). The aim of the study is to evaluate the effect of replacement in the everyday diet of saturated fats (butter) with unsaturated fats (canola oil-based spread and canola oil added to main meals) in centrally obese shift workers on changes in body weight and body composition parameters as well as on changes in CMtS markers.

研究概览

地位

未知

条件

干预/治疗

详细说明

The study was designed as a randomized clinical trial to investigate the effects of the dietary intervention with moderate in fat content (~35% energy as fat) for 12 weeks on the improvement of cardiometabolic risk factors in centrally obese shift workers. Forty centrally obese shift workers (waist circumference ≥94 cm) were randomized (1:1) to the experimental group (n = 20) or the control group (n = 20). Eligibility criteria included: aged between 30-60 years, working rotating shifts for at least 5 years and working night shifts minimum five times a month. Excluded criteria was described in the point "Eligibility". Written informed consent was obtained from all of the participants, and the local ethic committee approved the study. The dietary intervention was mainly based on the simple rearrangement of shift workers' diets by replacing food items including SFA (e.g. butter) with those being sources of unsaturated fatty acids (UFA), mainly canola oil (given to the diet as spread or this oil was added separately to main meals)

研究类型

介入性

注册 (预期的)

40

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

  • 波兰
      • Poznań、波兰、60-624
        • 招聘中
        • Poznan University of Life Science
        • 接触：
        • 接触：
        • 首席研究员：
          • Agnieszka Kuleta-Koberska, Msc

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

30年 至 60年 (成人)

接受健康志愿者

是的

有资格学习的性别

男性

描述

Inclusion Criteria:

  • centrally obese (≥ 94cm) male
  • aged between 30-60 years,
  • working rotating shifts for at least 5 years and working night shifts minimum five times a month,

Exclusion Criteria:

  • diabetes, familial hypercholesterolemia, thyroid and parathyroid diseases, non-specific intestinal diseases, celiac disease, phenylketonuria,
  • taking medication for lowering blood lipids such as statins,
  • weight loss therapy for 3 months before the intervention,
  • allergies and intolerances
  • consuming high-proof alcoholic beverages (>2 portions/week)

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：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 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：Intervention group
Isocaloric diet, based on individual energy requirements calculated from indirect calorimetry and physical activity adjustment Participants will be asked to eat daily ~50g canola oil
行为的：Intervention group
Isocaloric diet including ~50g canola oil
有源比较器：Control group
Standard dietary advice that is used as current best practice in the treatment of lipid disturbances of European Society of Cardiology and European Atherosclerosis Society (ESC/EAS) Guidelines for the management of dyslipidemias)
行为的：Control group
ESC/EAS Guidelines for the management of dyslipidemias

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
Waist circumference (WC)
大体时间：Baseline, 4, 8 and 12 week
Changes in WC within groups and between groups
Baseline, 4, 8 and 12 week
HDL-cholesterol (HDL-C)
大体时间：Baseline, 12 week
Changes in HDL-C within groups and between groups
Baseline, 12 week
LDL-cholesterol (LDL-C)
大体时间：Baseline, 12 week
Changes in LDL-C within groups and between groups
Baseline, 12 week
Triglycerides (TG)
大体时间：Baseline, 12 week
Changes in TG within groups and between groups
Baseline, 12 week
Glucose (GLU)
大体时间：Baseline, 12 week
Changes in GLU within groups and between groups
Baseline, 12 week
Blood pressure (BP)
大体时间：Baseline, 12 week
Changes in BP within groups and between groups
Baseline, 12 week
Body weight (BW)
大体时间：Baseline, 4, 8 and 12 week
Changes in BW within groups and between groups
Baseline, 4, 8 and 12 week
Fat mass (FM)
大体时间：Baseline, 4, 8 and 12 week
Changes in FM within groups and between groups
Baseline, 4, 8 and 12 week

次要结果测量

结果测量
措施说明
大体时间
Insulin (INS)
大体时间：Baseline, 12 week
Changes in INS within groups and between groups
Baseline, 12 week
High-sensitivity C-reactive Protein (hs-CRP)
大体时间：Baseline, 12 week
Changes in hs-CRP within groups and between groups
Baseline, 12 week
Cardiotrophin-1 (CT-1)
大体时间：Baseline, 12 week
Changes in CT-1 within groups and between groups
Baseline, 12 week
Lipase (LPS)
大体时间：Baseline, 12 week
Changes in LPS within groups and between groups
Baseline, 12 week
Cholinesterase (CHE)
大体时间：Baseline, 12 week
Changes in CHE within groups and between groups respectively
Baseline, 12 week
Alanine transaminase (ALT)
大体时间：Baseline, 12 week
Changes in ALT within groups and between groups
Baseline, 12 week
Aspartate transaminase (AST)
大体时间：Baseline, 12 week
Changes in AST within groups and between groups
Baseline, 12 week
Gamma-glutamyltransferase (GGTP)
大体时间：Baseline, 12 week
Changes in GGTP within groups and between groups
Baseline, 12 week
Melatonin (MEL)
大体时间：Baseline, 12 week
Changes in MEL within groups and between groups
Baseline, 12 week
Fatty acids (FA) erythrocyte membranes concentration
大体时间：Baseline, 12 week
Changes in FA within groups and between groups
Baseline, 12 week
Dietary intake
大体时间：Baseline, 4, 8, 12 week
Changes in dietary intake within groups and between groups
Baseline, 4, 8, 12 week

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

Poznan University of Life Sciences

调查人员

  • 首席研究员：Agnieszka Kuleta-Koberska, Msc、Poznan University of Life Sciences

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 (实际的)

2018年10月30日

初级完成 (预期的)

2019年10月30日

研究完成 (预期的)

2019年12月31日

研究注册日期

首次提交

2019年6月5日

首先提交符合 QC 标准的

2019年6月5日

首次发布 (实际的)

2019年6月6日

研究记录更新

最后更新发布 (实际的)

2019年6月10日

上次提交的符合 QC 标准的更新

2019年6月6日

最后验证

2019年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • IoHNaD

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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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