Clinical trial NCT03977558: Health Effect of Canola Oil Consumption in Shift Workers
Official title: The Effect of Canola Oil Consumption on the Selected Cardiometabolic Parameters in a Group of Shift Workers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shift-Work Related Sleep Disturbance
Metabolic Syndrome
Diet Modification
Work-Related Condition
Keywords: Shift Work
Night Work
Rotating Shift Work
Metabolic Syndrome
Diet Therapy
Canola oil
Fatty Acids
Cardiometabolic parameters
Lead sponsor: Poznan University of Life Sciences
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 40
Sex: MALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: 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)

Primary outcomes:
measure: Waist circumference (WC)
timeFrame: Baseline, 4, 8 and 12 week
measure: HDL-cholesterol (HDL-C)
timeFrame: Baseline, 12 week
measure: LDL-cholesterol (LDL-C)
timeFrame: Baseline, 12 week
measure: Triglycerides (TG)
timeFrame: Baseline, 12 week
measure: Glucose (GLU)
timeFrame: Baseline, 12 week
measure: Blood pressure (BP)
timeFrame: Baseline, 12 week
measure: Body weight (BW)
timeFrame: Baseline, 4, 8 and 12 week
measure: Fat mass (FM)
timeFrame: Baseline, 4, 8 and 12 week
Secondary outcomes:
measure: Insulin (INS)
timeFrame: Baseline, 12 week
measure: High-sensitivity C-reactive Protein (hs-CRP)
timeFrame: Baseline, 12 week
measure: Cardiotrophin-1 (CT-1)
timeFrame: Baseline, 12 week
measure: Lipase (LPS)
timeFrame: Baseline, 12 week
measure: Cholinesterase (CHE)
timeFrame: Baseline, 12 week
measure: Alanine transaminase (ALT)
timeFrame: Baseline, 12 week
measure: Aspartate transaminase (AST)
timeFrame: Baseline, 12 week
measure: Gamma-glutamyltransferase (GGTP)
timeFrame: Baseline, 12 week
measure: Melatonin (MEL)
timeFrame: Baseline, 12 week
measure: Fatty acids (FA) erythrocyte membranes concentration
timeFrame: Baseline, 12 week
measure: Dietary intake
timeFrame: Baseline, 4, 8, 12 week
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Poznan University of Life Science
Study officials:
affiliation: Poznan University of Life Sciences
name: Agnieszka Kuleta-Koberska, Msc
role: PRINCIPAL_INVESTIGATOR
References: