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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03977558
Other study ID # IoHNaD
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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