- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03977558
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
Status
Ukendt
Betingelser
Intervention / Behandling
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
- Navn: Joanna Bajerska, Prof.
- Telefonnummer: +48618466056
- E-mail: joanna.bajerska@up.poznan.pl
Undersøgelse Kontakt Backup
- Navn: Agnieszka Kuleta-Koberska, MSc
- Telefonnummer: +48618467594
- E-mail: agnieszka.kuleta@up.poznan.pl
Studiesteder
-
-
-
Poznań, Polen, 60-624
- Rekruttering
- Poznan University of Life Science
-
Kontakt:
- Joanna Bajerska, Prof.
- Telefonnummer: +48618466056
- E-mail: joanna.bajerska@up.poznan.pl
-
Kontakt:
- Agnieszka Kuleta-Koberska, MSc
- Telefonnummer: +48618487594
- E-mail: agnieszka.kuleta@up.poznan.pl
-
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
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IoHNaD
Plan for individuelle deltagerdata (IPD)
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