Health Effect of Canola Oil Consumption in Shift Workers

Not Applicable

• Conditions: Diet Modification; Shift-Work Related Sleep Disturbance; Work-Related Condition; Metabolic Syndrome
• Interventions: Behavioral: Control group; Behavioral: Intervention group

• Registration Number: NCT03977558
• Lead Sponsor: Poznan University of Life Sciences

Brief Summary

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

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)

Study Timeline

• Study Start: 2018-10-30
• Status Verified: 2019-06
• Study First Submitted: 2019-06-05
• Study First Submitted QC: 2019-06-05
• Study First Posted: 2019-06-06
• Last Update Submitted: 2019-06-06
• Last Update Posted: 2019-06-10
• Primary Completion: 2019-10-30
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	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)
Intervention group	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Poznan University of Life Science; 🇵🇱 Poznań, Poland