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Health Effect of Canola Oil Consumption in Shift Workers

6. juni 2019 oppdatert av: 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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert 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)

Studietype

Intervensjonell

Registrering (Forventet)

40

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Polen
      • Poznań, Polen, 60-624
        • Rekruttering
        • Poznan University of Life Science
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Agnieszka Kuleta-Koberska, Msc

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

30 år til 60 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Mann

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Atferdsmessig: Intervention group
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)
Atferdsmessig: Control group
ESC/EAS Guidelines for the management of dyslipidemias

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Poznan University of Life Sciences

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

30. oktober 2018

Primær fullføring (Forventet)

30. oktober 2019

Studiet fullført (Forventet)

31. desember 2019

Datoer for studieregistrering

Først innsendt

5. juni 2019

Først innsendt som oppfylte QC-kriteriene

5. juni 2019

Først lagt ut (Faktiske)

6. juni 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. juni 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. juni 2019

Sist bekreftet

1. juni 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IoHNaD

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