Health Effect of Canola Oil Consumption in Shift Workers

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03977558
• Other study ID #: IoHNaD
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2019
• Source: Poznan University of Life Sciences
• Contact: Agnieszka Kuleta-Koberska, MSc
• Phone: +48618467594
• Email: agnieszka.kuleta[@]up.poznan.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diet Modification
• Dyssomnias
• Metabolic Syndrome
• Parasomnias
• Shift-Work Related Sleep Disturbance
• Sleep Wake Disorders
• Work-Related Condition

Intervention

Behavioral:
• Intervention group
Isocaloric diet including ~50g canola oil
• Control group
ESC/EAS Guidelines for the management of dyslipidemias

Locations

Country	Name	City	State
Poland	Poznan University of Life Science	Poznan

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Life Sciences

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Waist circumference (WC)	Changes in WC within groups and between groups	Baseline, 4, 8 and 12 week
Primary	HDL-cholesterol (HDL-C)	Changes in HDL-C within groups and between groups	Baseline, 12 week
Primary	LDL-cholesterol (LDL-C)	Changes in LDL-C within groups and between groups	Baseline, 12 week
Primary	Triglycerides (TG)	Changes in TG within groups and between groups	Baseline, 12 week
Primary	Glucose (GLU)	Changes in GLU within groups and between groups	Baseline, 12 week
Primary	Blood pressure (BP)	Changes in BP within groups and between groups	Baseline, 12 week
Primary	Body weight (BW)	Changes in BW within groups and between groups	Baseline, 4, 8 and 12 week
Primary	Fat mass (FM)	Changes in FM within groups and between groups	Baseline, 4, 8 and 12 week
Secondary	Insulin (INS)	Changes in INS within groups and between groups	Baseline, 12 week
Secondary	High-sensitivity C-reactive Protein (hs-CRP)	Changes in hs-CRP within groups and between groups	Baseline, 12 week
Secondary	Cardiotrophin-1 (CT-1)	Changes in CT-1 within groups and between groups	Baseline, 12 week
Secondary	Lipase (LPS)	Changes in LPS within groups and between groups	Baseline, 12 week
Secondary	Cholinesterase (CHE)	Changes in CHE within groups and between groups respectively	Baseline, 12 week
Secondary	Alanine transaminase (ALT)	Changes in ALT within groups and between groups	Baseline, 12 week
Secondary	Aspartate transaminase (AST)	Changes in AST within groups and between groups	Baseline, 12 week
Secondary	Gamma-glutamyltransferase (GGTP)	Changes in GGTP within groups and between groups	Baseline, 12 week
Secondary	Melatonin (MEL)	Changes in MEL within groups and between groups	Baseline, 12 week
Secondary	Fatty acids (FA) erythrocyte membranes concentration	Changes in FA within groups and between groups	Baseline, 12 week
Secondary	Dietary intake	Changes in dietary intake within groups and between groups	Baseline, 4, 8, 12 week