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

Sponsor

Oslo University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02589769

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease Dietary Modification Cardiovascular Risk Factors	Other: unsaturated fat for saturated fat Other: saturated fat	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

83 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Sep 1, 2016

Actual Primary Completion Date :

Feb 1, 2018

Actual Study Completion Date :

Feb 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: unsaturated fat an intervention diet substituting unsaturated fats from oil and nuts for saturated fats from meat and dairy foods	Other: unsaturated fat for saturated fat Substituting unsaturated fat for saturated fat
Active Comparator: saturated fat a control diet with whole fat dairy and meat with saturated fats that are not fat reduced.	Other: saturated fat a control diet with whole fat dairy and meat with saturated fats that are not fat reduced

Arm

Intervention/Treatment

Experimental: unsaturated fat

an intervention diet substituting unsaturated fats from oil and nuts for saturated fats from meat and dairy foods

Other: unsaturated fat for saturated fat

Substituting unsaturated fat for saturated fat

Active Comparator: saturated fat

a control diet with whole fat dairy and meat with saturated fats that are not fat reduced.

Other: saturated fat

a control diet with whole fat dairy and meat with saturated fats that are not fat reduced

Outcome Measures

Primary Outcome Measures

Serum lipids in normal weight and obese subjects with elevated LDL cholesterol. [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.

Secondary Outcome Measures

C-reactive protein in normal weight and obese individuals [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
Serum PCSK9 in normal weight and obese individuals [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
Fasting glucose and HbA1C [10 weeks]
Compare the effect of substitution of unsaturated fat from nuts and oils for saturated fat on fasting glucose and HbA1C

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oslo Universitetssykehus, Ullevål	Oslo		Norway	0424

Sponsors and Collaborators

Oslo University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tine Mejlbo Sundfør, M.Sc in Nutrition, Oslo University Hospital

ClinicalTrials.gov Identifier:

NCT02589769

Other Study ID Numbers:

1786 (REK(

First Posted:

Oct 28, 2015

Last Update Posted:

Apr 5, 2018

Last Verified:

Sep 1, 2016

Additional relevant MeSH terms:

Cardiovascular Diseases

Study Results

No Results Posted as of Apr 5, 2018