Effects of Reduction in Saturated Fat on Cholesterol and Lipoproteins in Lean and Obese Persons

Cardiovascular Disease Clinical Trial

Official title:

Effects of Reduction in Saturated Fat on Cholesterol and Lipoproteins in Lean and Obese Persons

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02589769
• Other study ID #: 1786 (REK(
• Status: Completed
• Phase: N/A
• First received: June 16, 2015
• Last updated: April 3, 2018
• Start date: September 2016
• Est. completion date: February 2018

Study information

• Verified date: September 2016
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Cardiovascular Risk Factors
• Dietary Modification

Intervention

Other:
• unsaturated fat for saturated fat
Substituting unsaturated fat for saturated fat
• saturated fat
a control diet with whole fat dairy and meat with saturated fats that are not fat reduced

Locations

Country	Name	City	State
Norway	Oslo Universitetssykehus, Ullevål	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Serum PCSK9 in normal weight and obese individuals	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
Secondary	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