Health Effect of Canola Oil Consumption in Shift Workers

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.

Study Overview

• Status: Unknown
• Conditions: Metabolic Syndrome; Diet Modification; Work-Related Condition; Shift-Work Related Sleep Disturbance
• Intervention / Treatment: Behavioral: Intervention group; Behavioral: Control group

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Poznań, Poland, 60-624
    • Recruiting
    • Poznan University of Life Science
    • Contact: Joanna Bajerska, Prof.; Phone Number: +48618466056; Email: joanna.bajerska@up.poznan.pl
    • Contact: Agnieszka Kuleta-Koberska, MSc; Phone Number: +48618487594; Email: agnieszka.kuleta@up.poznan.pl
    • Principal Investigator: Agnieszka Kuleta-Koberska, Msc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: Intervention group; Isocaloric diet including ~50g canola oil
Active Comparator: 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)	Behavioral: Control group; ESC/EAS Guidelines for the management of dyslipidemias

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Poznan University of Life Sciences
• Investigators: Principal Investigator: Agnieszka Kuleta-Koberska, Msc, Poznan University of Life Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2018
• Primary Completion (Anticipated): October 30, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: June 5, 2019
• First Submitted That Met QC Criteria: June 5, 2019
• First Posted (Actual): June 6, 2019

Study Record Updates

• Last Update Posted (Actual): June 10, 2019
• Last Update Submitted That Met QC Criteria: June 6, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Metabolic Syndrome; Cardiometabolic parameters; Fatty Acids; Shift Work; Diet Therapy; Canola oil; Night Work; Rotating Shift Work
• Additional Relevant MeSH Terms: Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Sleep Wake Disorders; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome; Dyssomnias; Parasomnias
• Other Study ID Numbers: IoHNaD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No