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Health Effect of Canola Oil Consumption in Shift Workers

6 juni 2019 uppdaterad 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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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)

Studietyp

Interventionell

Inskrivning (Förväntat)

40

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Polen
      • Poznań, Polen, 60-624
        • Rekrytering
        • Poznan University of Life Science
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • Agnieszka Kuleta-Koberska, Msc

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

30 år till 60 år (Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Manlig

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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
Beteende: 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)
Beteende: Control group
ESC/EAS Guidelines for the management of dyslipidemias

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Poznan University of Life Sciences

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

30 oktober 2018

Primärt slutförande (Förväntat)

30 oktober 2019

Avslutad studie (Förväntat)

31 december 2019

Studieregistreringsdatum

Först inskickad

5 juni 2019

Först inskickad som uppfyllde QC-kriterierna

5 juni 2019

Första postat (Faktisk)

6 juni 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 juni 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 juni 2019

Senast verifierad

1 juni 2019

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • IoHNaD

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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