Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| unsaturated fat | Experimental | an intervention diet substituting unsaturated fats from oil and nuts for saturated fats from meat and dairy foods |
|
| saturated fat | Active Comparator | a control diet with whole fat dairy and meat with saturated fats that are not fat reduced. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| unsaturated fat for saturated fat | Other | Substituting unsaturated fat for saturated fat |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Serum lipids in normal weight and obese subjects with elevated LDL cholesterol. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| C-reactive protein in normal weight and obese individuals | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo Universitetssykehus, Ullevål | Oslo | 0424 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31216575 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005224 | Fats, Unsaturated |
| D005227 | Fatty Acids |
| ID | Term |
|---|---|
| D005223 | Fats |
| D008055 | Lipids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| saturated fat |
| Other |
a control diet with whole fat dairy and meat with saturated fats that are not fat reduced |
|
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 | Compare the effect of substitution of unsaturated fat from nuts and oils for saturated fat on fasting glucose and HbA1C | 10 weeks |