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出境医 / 临床实验 / Health Effect of Canola Oil Consumption in Shift Workers

Health Effect of Canola Oil Consumption in Shift Workers

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.

Condition or disease Intervention/treatment Phase
Shift-Work Related Sleep Disturbance Metabolic Syndrome Diet Modification Work-Related Condition Behavioral: Intervention group Behavioral: Control group Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Canola Oil Consumption on the Selected Cardiometabolic Parameters in a Group of Shift Workers
Actual Study Start Date : October 30, 2018
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : December 31, 2019
Arms and Interventions
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
Outcome Measures
Primary Outcome Measures :
  1. Waist circumference (WC) [ Time Frame: Baseline, 4, 8 and 12 week ]
    Changes in WC within groups and between groups

  2. HDL-cholesterol (HDL-C) [ Time Frame: Baseline, 12 week ]
    Changes in HDL-C within groups and between groups

  3. LDL-cholesterol (LDL-C) [ Time Frame: Baseline, 12 week ]
    Changes in LDL-C within groups and between groups

  4. Triglycerides (TG) [ Time Frame: Baseline, 12 week ]
    Changes in TG within groups and between groups

  5. Glucose (GLU) [ Time Frame: Baseline, 12 week ]
    Changes in GLU within groups and between groups

  6. Blood pressure (BP) [ Time Frame: Baseline, 12 week ]
    Changes in BP within groups and between groups

  7. Body weight (BW) [ Time Frame: Baseline, 4, 8 and 12 week ]
    Changes in BW within groups and between groups

  8. Fat mass (FM) [ Time Frame: Baseline, 4, 8 and 12 week ]
    Changes in FM within groups and between groups


Secondary Outcome Measures :
  1. Insulin (INS) [ Time Frame: Baseline, 12 week ]
    Changes in INS within groups and between groups

  2. High-sensitivity C-reactive Protein (hs-CRP) [ Time Frame: Baseline, 12 week ]
    Changes in hs-CRP within groups and between groups

  3. Cardiotrophin-1 (CT-1) [ Time Frame: Baseline, 12 week ]
    Changes in CT-1 within groups and between groups

  4. Lipase (LPS) [ Time Frame: Baseline, 12 week ]
    Changes in LPS within groups and between groups

  5. Cholinesterase (CHE) [ Time Frame: Baseline, 12 week ]
    Changes in CHE within groups and between groups respectively

  6. Alanine transaminase (ALT) [ Time Frame: Baseline, 12 week ]
    Changes in ALT within groups and between groups

  7. Aspartate transaminase (AST) [ Time Frame: Baseline, 12 week ]
    Changes in AST within groups and between groups

  8. Gamma-glutamyltransferase (GGTP) [ Time Frame: Baseline, 12 week ]
    Changes in GGTP within groups and between groups

  9. Melatonin (MEL) [ Time Frame: Baseline, 12 week ]
    Changes in MEL within groups and between groups

  10. Fatty acids (FA) erythrocyte membranes concentration [ Time Frame: Baseline, 12 week ]
    Changes in FA within groups and between groups

  11. Dietary intake [ Time Frame: Baseline, 4, 8, 12 week ]
    Changes in dietary intake within groups and between groups


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Agnieszka Kuleta-Koberska, MSc +48618467594 agnieszka.kuleta@up.poznan.pl
Contact: Joanna Bajerska, Prof. +48618466056 joanna.bajerska@up.poznan.pl

Locations
Layout table for location information
Poland
Poznan University of Life Science Recruiting
Poznań, Poland, 60-624
Contact: Agnieszka Kuleta-Koberska, MSc    +48618487594    agnieszka.kuleta@up.poznan.pl   
Contact: Joanna Bajerska, Prof.    +48618466056    joanna.bajerska@up.poznan.pl   
Principal Investigator: Agnieszka Kuleta-Koberska, Msc         
Sponsors and Collaborators
Poznan University of Life Sciences
Investigators
Layout table for investigator information
Principal Investigator: Agnieszka Kuleta-Koberska, Msc Poznan University of Life Sciences
Tracking Information
First Submitted Date  ICMJE June 5, 2019
First Posted Date  ICMJE June 6, 2019
Last Update Posted Date June 10, 2019
Actual Study Start Date  ICMJE October 30, 2018
Estimated Primary Completion Date October 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
  • Waist circumference (WC) [ Time Frame: Baseline, 4, 8 and 12 week ]
    Changes in WC within groups and between groups
  • HDL-cholesterol (HDL-C) [ Time Frame: Baseline, 12 week ]
    Changes in HDL-C within groups and between groups
  • LDL-cholesterol (LDL-C) [ Time Frame: Baseline, 12 week ]
    Changes in LDL-C within groups and between groups
  • Triglycerides (TG) [ Time Frame: Baseline, 12 week ]
    Changes in TG within groups and between groups
  • Glucose (GLU) [ Time Frame: Baseline, 12 week ]
    Changes in GLU within groups and between groups
  • Blood pressure (BP) [ Time Frame: Baseline, 12 week ]
    Changes in BP within groups and between groups
  • Body weight (BW) [ Time Frame: Baseline, 4, 8 and 12 week ]
    Changes in BW within groups and between groups
  • Fat mass (FM) [ Time Frame: Baseline, 4, 8 and 12 week ]
    Changes in FM within groups and between groups
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
  • Insulin (INS) [ Time Frame: Baseline, 12 week ]
    Changes in INS within groups and between groups
  • High-sensitivity C-reactive Protein (hs-CRP) [ Time Frame: Baseline, 12 week ]
    Changes in hs-CRP within groups and between groups
  • Cardiotrophin-1 (CT-1) [ Time Frame: Baseline, 12 week ]
    Changes in CT-1 within groups and between groups
  • Lipase (LPS) [ Time Frame: Baseline, 12 week ]
    Changes in LPS within groups and between groups
  • Cholinesterase (CHE) [ Time Frame: Baseline, 12 week ]
    Changes in CHE within groups and between groups respectively
  • Alanine transaminase (ALT) [ Time Frame: Baseline, 12 week ]
    Changes in ALT within groups and between groups
  • Aspartate transaminase (AST) [ Time Frame: Baseline, 12 week ]
    Changes in AST within groups and between groups
  • Gamma-glutamyltransferase (GGTP) [ Time Frame: Baseline, 12 week ]
    Changes in GGTP within groups and between groups
  • Melatonin (MEL) [ Time Frame: Baseline, 12 week ]
    Changes in MEL within groups and between groups
  • Fatty acids (FA) erythrocyte membranes concentration [ Time Frame: Baseline, 12 week ]
    Changes in FA within groups and between groups
  • Dietary intake [ Time Frame: Baseline, 4, 8, 12 week ]
    Changes in dietary intake within groups and between groups
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Health Effect of Canola Oil Consumption in Shift Workers
Official Title  ICMJE The Effect of Canola Oil Consumption on the Selected Cardiometabolic Parameters in a Group of Shift Workers
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)
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Shift-Work Related Sleep Disturbance
  • Metabolic Syndrome
  • Diet Modification
  • Work-Related Condition
Intervention  ICMJE
  • Behavioral: Intervention group
    Isocaloric diet including ~50g canola oil
  • Behavioral: Control group
    ESC/EAS Guidelines for the management of dyslipidemias
Study Arms  ICMJE
  • 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
    Intervention: Behavioral: Intervention group
  • 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)
    Intervention: Behavioral: Control group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 5, 2019) 		40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date October 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 30 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03977558
Other Study ID Numbers  ICMJE IoHNaD
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Agnieszka Kuleta-Koberska, Poznan University of Life Sciences
Study Sponsor  ICMJE Poznan University of Life Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Agnieszka Kuleta-Koberska, Msc Poznan University of Life Sciences
PRS Account Poznan University of Life Sciences
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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