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Health Effect of Canola Oil Consumption in Shift Workers

Primary Purpose

Shift-Work Related Sleep Disturbance, Metabolic Syndrome, Diet Modification

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Intervention group
Control group
Sponsored by
Poznan University of Life Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shift-Work Related Sleep Disturbance focused on measuring Shift Work, Night Work, Rotating Shift Work, Metabolic Syndrome, Diet Therapy, Canola oil, Fatty Acids, Cardiometabolic parameters

Eligibility Criteria

30 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Poznan University of Life ScienceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Control group

Arm Description

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

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)

Outcomes

Primary Outcome Measures

Waist circumference (WC)
Changes in WC within groups and between groups
HDL-cholesterol (HDL-C)
Changes in HDL-C within groups and between groups
LDL-cholesterol (LDL-C)
Changes in LDL-C within groups and between groups
Triglycerides (TG)
Changes in TG within groups and between groups
Glucose (GLU)
Changes in GLU within groups and between groups
Blood pressure (BP)
Changes in BP within groups and between groups
Body weight (BW)
Changes in BW within groups and between groups
Fat mass (FM)
Changes in FM within groups and between groups

Secondary Outcome Measures

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

Full Information

First Posted
June 5, 2019
Last Updated
June 6, 2019
Sponsor
Poznan University of Life Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03977558
Brief Title
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

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 30, 2018 (Actual)
Primary Completion Date
October 30, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Poznan University of Life Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Intervention group
Intervention Description
Isocaloric diet including ~50g canola oil
Intervention Type
Behavioral
Intervention Name(s)
Control group
Intervention Description
ESC/EAS Guidelines for the management of dyslipidemias
Primary Outcome Measure Information:
Title
Waist circumference (WC)
Description
Changes in WC within groups and between groups
Time Frame
Baseline, 4, 8 and 12 week
Title
HDL-cholesterol (HDL-C)
Description
Changes in HDL-C within groups and between groups
Time Frame
Baseline, 12 week
Title
LDL-cholesterol (LDL-C)
Description
Changes in LDL-C within groups and between groups
Time Frame
Baseline, 12 week
Title
Triglycerides (TG)
Description
Changes in TG within groups and between groups
Time Frame
Baseline, 12 week
Title
Glucose (GLU)
Description
Changes in GLU within groups and between groups
Time Frame
Baseline, 12 week
Title
Blood pressure (BP)
Description
Changes in BP within groups and between groups
Time Frame
Baseline, 12 week
Title
Body weight (BW)
Description
Changes in BW within groups and between groups
Time Frame
Baseline, 4, 8 and 12 week
Title
Fat mass (FM)
Description
Changes in FM within groups and between groups
Time Frame
Baseline, 4, 8 and 12 week
Secondary Outcome Measure Information:
Title
Insulin (INS)
Description
Changes in INS within groups and between groups
Time Frame
Baseline, 12 week
Title
High-sensitivity C-reactive Protein (hs-CRP)
Description
Changes in hs-CRP within groups and between groups
Time Frame
Baseline, 12 week
Title
Cardiotrophin-1 (CT-1)
Description
Changes in CT-1 within groups and between groups
Time Frame
Baseline, 12 week
Title
Lipase (LPS)
Description
Changes in LPS within groups and between groups
Time Frame
Baseline, 12 week
Title
Cholinesterase (CHE)
Description
Changes in CHE within groups and between groups respectively
Time Frame
Baseline, 12 week
Title
Alanine transaminase (ALT)
Description
Changes in ALT within groups and between groups
Time Frame
Baseline, 12 week
Title
Aspartate transaminase (AST)
Description
Changes in AST within groups and between groups
Time Frame
Baseline, 12 week
Title
Gamma-glutamyltransferase (GGTP)
Description
Changes in GGTP within groups and between groups
Time Frame
Baseline, 12 week
Title
Melatonin (MEL)
Description
Changes in MEL within groups and between groups
Time Frame
Baseline, 12 week
Title
Fatty acids (FA) erythrocyte membranes concentration
Description
Changes in FA within groups and between groups
Time Frame
Baseline, 12 week
Title
Dietary intake
Description
Changes in dietary intake within groups and between groups
Time Frame
Baseline, 4, 8, 12 week

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Agnieszka Kuleta-Koberska, MSc
Phone
+48618467594
Email
agnieszka.kuleta@up.poznan.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Joanna Bajerska, Prof.
Phone
+48618466056
Email
joanna.bajerska@up.poznan.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnieszka Kuleta-Koberska, Msc
Organizational Affiliation
Poznan University of Life Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Poznan University of Life Science
City
Poznań
ZIP/Postal Code
60-624
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnieszka Kuleta-Koberska, MSc
Phone
+48618487594
Email
agnieszka.kuleta@up.poznan.pl
First Name & Middle Initial & Last Name & Degree
Joanna Bajerska, Prof.
Phone
+48618466056
Email
joanna.bajerska@up.poznan.pl
First Name & Middle Initial & Last Name & Degree
Agnieszka Kuleta-Koberska, Msc

12. IPD Sharing Statement

Plan to Share IPD
No

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Health Effect of Canola Oil Consumption in Shift Workers

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