Effects of Reduction in Saturated Fat on Cholesterol and Lipoproteins in Lean and Obese Persons
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
Background: Increased intake of saturated fat may influence LDL cholesterol and other cardiovascular risk factors different in normal weight and obese subjects. Methods: The study is a randomized controlled clinical trial in 84 men and women between 21 to 70 years with normal BMI (25 kg/m2) or obesity (BMI 30-45 kg/m2) and elevated LDL cholesterol (>3.0 mmol/l). Dietary intervention: Randomization will be to one of two balanced weight maintenance Mediterranean-type diets that differ in their fat sources: an intervention diet substituting unsaturated fats from oil and nuts for saturated fats from meat and dairy foods, and a control diet with whole fat dairy and meat with saturated fats that are not fat reduced.
Primary research question: Compare the effect of substitution of unsaturated fat from nuts and oils for saturated fat from meat and dairy foods on serum lipids in normal weight and obese subjects with elevated LDL cholesterol.
Secondary research questions: Compare the effect of substitution of unsaturated fat from nuts and oils for saturated fat on cardiometabolic risk factors including insulin resistance, inflammation and serum PCSK9 in normal weight and obese individuals.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Oslo, Norge, 0424
- Oslo universitetssykehus, Ullevål
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Men and women aged 21 to 70 years with normal BMI (25 kg/m2) or obesity (BMI 30-45 kg/m2) and elevated LDL cholesterol (> 3.0 mmol/l).
Exclusion Criteria:
- Diabetes types 1 and 2
- History of CVD including myocardial infarction, percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), stroke, transient ischemic attack (TIA) or other atherosclerotic disease, eating disorder and other secondary causes of hyperlipidemia.
- Use of statins or other cholesterol-modifying drugs.
- Genetic lipid disorder.
- Gastrointestinal disorders that limit food choices.
- Psychiatric illness, drug or alcohol abuse.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: unsaturated fat
an intervention diet substituting unsaturated fats from oil and nuts for saturated fats from meat and dairy foods
|
Substituting unsaturated fat for saturated fat
|
|
Aktiv komparator: saturated fat
a control diet with whole fat dairy and meat with saturated fats that are not fat reduced.
|
a control diet with whole fat dairy and meat with saturated fats that are not fat reduced
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Serum lipids in normal weight and obese subjects with elevated LDL cholesterol.
Tidsram: 10 weeks
|
Compare the effect of substitution of unsaturated fat from nuts and oils for saturated fat from meat and dairy foods on serum lipids in normal weight and obese subjects with elevated LDL cholesterol.
|
10 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
C-reactive protein in normal weight and obese individuals
Tidsram: 10 weeks
|
Compare the effect of substitution of unsaturated fat from nuts and oils for saturated fat on c-reactive protein in normal weight and obese individuals
|
10 weeks
|
|
Serum PCSK9 in normal weight and obese individuals
Tidsram: 10 weeks
|
Compare the effect of substitution of unsaturated fat from nuts and oils for saturated fat on inflammation in normal weight and obese individuals
|
10 weeks
|
|
Fasting glucose and HbA1C
Tidsram: 10 weeks
|
Compare the effect of substitution of unsaturated fat from nuts and oils for saturated fat on fasting glucose and HbA1C
|
10 weeks
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1786 (REK(
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .