The Effect of Canola Oil Consumption on the Selected Cardiometabolic Parameters in a Group of Shift Workers
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Waist circumference (WC)
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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,
排除标准
- •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)
结局指标
主要结局
Waist circumference (WC)
时间窗: Baseline, 4, 8 and 12 week
Changes in WC within groups and between groups
HDL-cholesterol (HDL-C)
时间窗: Baseline, 12 week
Changes in HDL-C within groups and between groups
LDL-cholesterol (LDL-C)
时间窗: Baseline, 12 week
Changes in LDL-C within groups and between groups
Triglycerides (TG)
时间窗: Baseline, 12 week
Changes in TG within groups and between groups
Glucose (GLU)
时间窗: Baseline, 12 week
Changes in GLU within groups and between groups
Blood pressure (BP)
时间窗: Baseline, 12 week
Changes in BP within groups and between groups
Body weight (BW)
时间窗: Baseline, 4, 8 and 12 week
Changes in BW within groups and between groups
Fat mass (FM)
时间窗: Baseline, 4, 8 and 12 week
Changes in FM within groups and between groups
次要结局
- Insulin (INS)(Baseline, 12 week)
- Cholinesterase (CHE)(Baseline, 12 week)
- Aspartate transaminase (AST)(Baseline, 12 week)
- Gamma-glutamyltransferase (GGTP)(Baseline, 12 week)
- Cardiotrophin-1 (CT-1)(Baseline, 12 week)
- High-sensitivity C-reactive Protein (hs-CRP)(Baseline, 12 week)
- Lipase (LPS)(Baseline, 12 week)
- Alanine transaminase (ALT)(Baseline, 12 week)
- Melatonin (MEL)(Baseline, 12 week)
- Fatty acids (FA) erythrocyte membranes concentration(Baseline, 12 week)
- Dietary intake(Baseline, 4, 8, 12 week)
研究者
Agnieszka Kuleta-Koberska
Principal Investigator
Poznan University of Life Sciences