Clinical trial NCT02589769: Effects of Reduction in Saturated Fat on Cholesterol and Lipoproteins in Lean and Obese Persons
Official title: Effects of Reduction in Saturated Fat on Cholesterol and Lipoproteins in Lean and Obese Persons
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Dietary Modification
Cardiovascular Risk Factors
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2015-10-28
Enrollment: 83
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A randomized controlled clinical trial comparing 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Serum lipids in normal weight and obese subjects with elevated LDL cholesterol.
timeFrame: 10 weeks
Secondary outcomes:
measure: C-reactive protein in normal weight and obese individuals
timeFrame: 10 weeks
measure: Serum PCSK9 in normal weight and obese individuals
timeFrame: 10 weeks
measure: Fasting glucose and HbA1C
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo Universitetssykehus, Ullevål
Study officials:
References:
citation: Sundfor TM, Svendsen M, Heggen E, Dushanov S, Klemsdal TO, Tonstad S. BMI modifies the effect of dietary fat on atherogenic lipids: a randomized clinical trial. Am J Clin Nutr. 2019 Oct 1;110(4):832-841. doi: 10.1093/ajcn/nqz113.