Health Effect of Canola Oil Consumption in Shift Workers

NCT03977558 | Unknown

• 1 other identifier: IoHNaD
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (11)

• Insulin (INS)

  Baseline, 12 week

• High-sensitivity C-reactive Protein (hs-CRP)

  Baseline, 12 week

• Cardiotrophin-1 (CT-1)

  Baseline, 12 week

• Lipase (LPS)

  Baseline, 12 week

• Cholinesterase (CHE)

  Baseline, 12 week

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Intervention group BEHAVIORAL

Isocaloric diet including \~50g canola oil

Intervention group

Control group BEHAVIORAL

ESC/EAS Guidelines for the management of dyslipidemias

Control group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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,

You may not qualify if:

• 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)

Sponsors & Collaborators

• Poznan University of Life Sciences: lead

Study Sites (1)

Poznan University of Life Science

Poznan, 60-624, Poland

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Agnieszka Kuleta-Koberska, Msc

  Poznan University of Life Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnieszka Kuleta-Koberska, MSc

CONTACT

+48618467594; agnieszka.kuleta@up.poznan.pl

Joanna Bajerska, Prof.

CONTACT

+48618466056; joanna.bajerska@up.poznan.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 6, 2019
• Study Start: October 30, 2018
• Primary Completion: October 30, 2019
• Study Completion: December 31, 2019
• Last Updated: June 10, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)