Health Effect of Canola Oil Consumption in Shift Workers

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

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

Conditions
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Shift-Work Related Sleep Disturbance, Metabolic Syndrome, Diet Modification, Work-Related Condition

Intervention / Treatment
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* Behavioral: Intervention group
* Behavioral: Control group


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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 | Behavioral: Intervention group<br>* Isocaloric diet including  50g canola oil<br>|
| Active Comparator: Control group<br>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) | Behavioral: Control group<br>* ESC/EAS Guidelines for the management of dyslipidemias<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist circumference (WC) | Changes in WC within groups and between groups | Baseline, 4, 8 and 12 week | 
| HDL-cholesterol (HDL-C) | Changes in HDL-C within groups and between groups | Baseline, 12 week | 
| LDL-cholesterol (LDL-C) | Changes in LDL-C within groups and between groups | Baseline, 12 week | 
| Triglycerides (TG) | Changes in TG within groups and between groups | Baseline, 12 week | 
| Glucose (GLU) | Changes in GLU within groups and between groups | Baseline, 12 week | 
| Blood pressure (BP) | Changes in BP within groups and between groups | Baseline, 12 week | 
| Body weight (BW) | Changes in BW within groups and between groups | Baseline, 4, 8 and 12 week | 
| Fat mass (FM) | Changes in FM within groups and between groups | Baseline, 4, 8 and 12 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin (INS) | Changes in INS within groups and between groups | Baseline, 12 week | 
| High-sensitivity C-reactive Protein (hs-CRP) | Changes in hs-CRP within groups and between groups | Baseline, 12 week | 
| Cardiotrophin-1 (CT-1) | Changes in CT-1 within groups and between groups | Baseline, 12 week | 
| Lipase (LPS) | Changes in LPS within groups and between groups | Baseline, 12 week | 
| Cholinesterase (CHE) | Changes in CHE within groups and between groups respectively | Baseline, 12 week | 
| Alanine transaminase (ALT) | Changes in ALT within groups and between groups | Baseline, 12 week | 
| Aspartate transaminase (AST) | Changes in AST within groups and between groups | Baseline, 12 week | 
| Gamma-glutamyltransferase (GGTP) | Changes in GGTP within groups and between groups | Baseline, 12 week | 
| Melatonin (MEL) | Changes in MEL within groups and between groups | Baseline, 12 week | 
| Fatty acids (FA) erythrocyte membranes concentration | Changes in FA within groups and between groups | Baseline, 12 week | 
| Dietary intake | Changes in dietary intake within groups and between groups | Baseline, 4, 8, 12 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shift Work, Night Work, Rotating Shift Work, Metabolic Syndrome, Diet Therapy, Canola oil, Fatty Acids, Cardiometabolic parameters