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Health Effect of Canola Oil Consumption in Shift Workers

6. juni 2019 opdateret af: Agnieszka Kuleta-Koberska, Poznan University of Life Sciences

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.

Studieoversigt

Detaljeret beskrivelse

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)

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

      • Poznań, Polen, 60-624
        • Rekruttering
        • Poznan University of Life Science
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Agnieszka Kuleta-Koberska, Msc

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

30 år til 60 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Isocaloric diet including ~50g canola oil
Aktiv komparator: 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)
ESC/EAS Guidelines for the management of dyslipidemias

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Waist circumference (WC)
Tidsramme: Baseline, 4, 8 and 12 week
Changes in WC within groups and between groups
Baseline, 4, 8 and 12 week
HDL-cholesterol (HDL-C)
Tidsramme: Baseline, 12 week
Changes in HDL-C within groups and between groups
Baseline, 12 week
LDL-cholesterol (LDL-C)
Tidsramme: Baseline, 12 week
Changes in LDL-C within groups and between groups
Baseline, 12 week
Triglycerides (TG)
Tidsramme: Baseline, 12 week
Changes in TG within groups and between groups
Baseline, 12 week
Glucose (GLU)
Tidsramme: Baseline, 12 week
Changes in GLU within groups and between groups
Baseline, 12 week
Blood pressure (BP)
Tidsramme: Baseline, 12 week
Changes in BP within groups and between groups
Baseline, 12 week
Body weight (BW)
Tidsramme: Baseline, 4, 8 and 12 week
Changes in BW within groups and between groups
Baseline, 4, 8 and 12 week
Fat mass (FM)
Tidsramme: Baseline, 4, 8 and 12 week
Changes in FM within groups and between groups
Baseline, 4, 8 and 12 week

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Insulin (INS)
Tidsramme: Baseline, 12 week
Changes in INS within groups and between groups
Baseline, 12 week
High-sensitivity C-reactive Protein (hs-CRP)
Tidsramme: Baseline, 12 week
Changes in hs-CRP within groups and between groups
Baseline, 12 week
Cardiotrophin-1 (CT-1)
Tidsramme: Baseline, 12 week
Changes in CT-1 within groups and between groups
Baseline, 12 week
Lipase (LPS)
Tidsramme: Baseline, 12 week
Changes in LPS within groups and between groups
Baseline, 12 week
Cholinesterase (CHE)
Tidsramme: Baseline, 12 week
Changes in CHE within groups and between groups respectively
Baseline, 12 week
Alanine transaminase (ALT)
Tidsramme: Baseline, 12 week
Changes in ALT within groups and between groups
Baseline, 12 week
Aspartate transaminase (AST)
Tidsramme: Baseline, 12 week
Changes in AST within groups and between groups
Baseline, 12 week
Gamma-glutamyltransferase (GGTP)
Tidsramme: Baseline, 12 week
Changes in GGTP within groups and between groups
Baseline, 12 week
Melatonin (MEL)
Tidsramme: Baseline, 12 week
Changes in MEL within groups and between groups
Baseline, 12 week
Fatty acids (FA) erythrocyte membranes concentration
Tidsramme: Baseline, 12 week
Changes in FA within groups and between groups
Baseline, 12 week
Dietary intake
Tidsramme: Baseline, 4, 8, 12 week
Changes in dietary intake within groups and between groups
Baseline, 4, 8, 12 week

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Agnieszka Kuleta-Koberska, Msc, Poznan University of Life Sciences

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. oktober 2018

Primær færdiggørelse (Forventet)

30. oktober 2019

Studieafslutning (Forventet)

31. december 2019

Datoer for studieregistrering

Først indsendt

5. juni 2019

Først indsendt, der opfyldte QC-kriterier

5. juni 2019

Først opslået (Faktiske)

6. juni 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juni 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. juni 2019

Sidst verificeret

1. juni 2019

Mere information

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