Effects of Reduction in Saturated Fat on Cholesterol and Lipoproteins in Lean and Obese Persons
1 other identifier
interventional
83
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2015
CompletedFirst Posted
Study publicly available on registry
October 28, 2015
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedApril 5, 2018
September 1, 2016
1.4 years
June 16, 2015
April 3, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
C-reactive protein in normal weight and obese individuals
10 weeks
Serum PCSK9 in normal weight and obese individuals
10 weeks
Fasting glucose and HbA1C
10 weeks
Study Arms (2)
unsaturated fat
EXPERIMENTALan intervention diet substituting unsaturated fats from oil and nuts for saturated fats from meat and dairy foods
saturated fat
ACTIVE COMPARATORa control diet with whole fat dairy and meat with saturated fats that are not fat reduced.
Interventions
a control diet with whole fat dairy and meat with saturated fats that are not fat reduced
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oslo Universitetssykehus, Ullevål
Oslo, 0424, Norway
Related Publications (1)
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.
PMID: 31216575DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.Sc in Nutrition
Study Record Dates
First Submitted
June 16, 2015
First Posted
October 28, 2015
Study Start
September 1, 2016
Primary Completion
February 1, 2018
Study Completion
February 1, 2018
Last Updated
April 5, 2018
Record last verified: 2016-09