Shift-Work Related Sleep DisturbanceNCT03977558
Health Effect of Canola Oil Consumption in Shift Workers
A study testing Intervention group in people with Shift-Work Related Sleep Disturbance and Metabolic Syndrome, run by Poznan University of Life Sciences at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Shift-Work Related Sleep Disturbance, Metabolic Syndrome, Diet Modification
- What is being tested?
- Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 30 Oct 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Poznan University of Life Science
Poznan, 60-624
Agnieszka Kuleta-Koberska, MSc, +48618487594, agnieszka.kuleta@up.poznan.pl
Joanna Bajerska, Prof., +48618466056, joanna.bajerska@up.poznan.pl
About this study
Official title: 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.
Read the 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)
- Conditions
- Shift-Work Related Sleep Disturbance, Metabolic Syndrome, Diet Modification, Work-Related Condition
- Being tested
- Intervention group, Control group
- Keywords
- Shift Work, Night Work, Rotating Shift Work, Metabolic Syndrome, Diet Therapy, Canola oil, Fatty Acids, Cardiometabolic parameters
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupBehavioural
Isocaloric diet including ~50g canola oil
Control groupBehavioural
ESC/EAS Guidelines for the management of dyslipidemias
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waist circumference (WC)
Changes in WC within groups and between groups
Measured: Baseline, 4, 8 and 12 week
HDL-cholesterol (HDL-C)
Changes in HDL-C within groups and between groups
Measured: Baseline, 12 week
LDL-cholesterol (LDL-C)
Changes in LDL-C within groups and between groups
Measured: Baseline, 12 week
Triglycerides (TG)
Changes in TG within groups and between groups
Measured: Baseline, 12 week
Glucose (GLU)
Changes in GLU within groups and between groups
Measured: Baseline, 12 week
Blood pressure (BP)
Changes in BP within groups and between groups
Measured: Baseline, 12 week
Body weight (BW)
Changes in BW within groups and between groups
Measured: Baseline, 4, 8 and 12 week
Fat mass (FM)
Changes in FM within groups and between groups
Measured: Baseline, 4, 8 and 12 week
Secondary outcomes (11)
Insulin (INS)
Changes in INS within groups and between groups
Measured: Baseline, 12 week
High-sensitivity C-reactive Protein (hs-CRP)
Changes in hs-CRP within groups and between groups
Measured: Baseline, 12 week
Cardiotrophin-1 (CT-1)
Changes in CT-1 within groups and between groups
Measured: Baseline, 12 week
Lipase (LPS)
Changes in LPS within groups and between groups
Measured: Baseline, 12 week
Cholinesterase (CHE)
Changes in CHE within groups and between groups respectively
Measured: Baseline, 12 week
Alanine transaminase (ALT)
Changes in ALT within groups and between groups
Measured: Baseline, 12 week
Aspartate transaminase (AST)
Changes in AST within groups and between groups
Measured: Baseline, 12 week
Gamma-glutamyltransferase (GGTP)
Changes in GGTP within groups and between groups
Measured: Baseline, 12 week
Melatonin (MEL)
Changes in MEL within groups and between groups
Measured: Baseline, 12 week
Fatty acids (FA) erythrocyte membranes concentration
Changes in FA within groups and between groups
Measured: Baseline, 12 week
Dietary intake
Changes in dietary intake within groups and between groups
Measured: Baseline, 4, 8, 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start30 Oct 2018
- Primary completion30 Oct 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shift-Work Related Sleep DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Life Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnieszka Kuleta-Koberska, Poznan University of Life Sciences
- Investigators
- Agnieszka Kuleta-Koberska, Msc, Principal investigator, Poznan University of Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977558
- Sponsor's protocol ID
- IoHNaD
- Status last verified
- Jun 2019
- First submitted
- 5 Jun 2019
- Last updated
- 10 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Canola Oil Consumption on the Selected Cardiometabolic Parameters in a Group of Shift Workers
- ClinicalTrials.gov ID
- NCT03977558
- Acronym / sponsor ID
- IoHNaD
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Poznan University of Life SciencesUniversity, hospital or other
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 30 Oct 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Intervention groupIsocaloric diet, based on individual energy requirements calculated from indirect calorimetry and physical activity adjustment Participants will be asked to eat daily ~50g canola oil |
| Control group | Active comparator | Behavioral: Control groupStandard 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) |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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,
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention groupIsocaloric diet including ~50g canola oil | Behavioural | Intervention group |
| Control groupESC/EAS Guidelines for the management of dyslipidemias | Behavioural | Control group |
Primary outcome
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
11 secondary outcomes
Insulin (INS)
Time frame: Baseline, 12 week
High-sensitivity C-reactive Protein (hs-CRP)
Time frame: Baseline, 12 week
Cardiotrophin-1 (CT-1)
Time frame: Baseline, 12 week
Lipase (LPS)
Time frame: Baseline, 12 week
Cholinesterase (CHE)
Time frame: Baseline, 12 week
Alanine transaminase (ALT)
Time frame: Baseline, 12 week
Aspartate transaminase (AST)
Time frame: Baseline, 12 week
Gamma-glutamyltransferase (GGTP)
Time frame: Baseline, 12 week
Melatonin (MEL)
Time frame: Baseline, 12 week
Fatty acids (FA) erythrocyte membranes concentration
Time frame: Baseline, 12 week
Dietary intake
Time frame: Baseline, 4, 8, 12 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnieszka Kuleta-Koberska, Msc principal investigator
Poznan University of Life Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Shift-Work Related Sleep Disturbance and Metabolic Syndrome, run by Poznan University of Life Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Agnieszka Kuleta-Koberska, MSc (+48618467594, agnieszka.kuleta@up.poznan.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Waist circumference (WC) (time frame: Baseline, 4, 8 and 12 week). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2019.