Cardiovascular DiseaseNCT02589769
Effects of Reduction in Saturated Fat on Cholesterol and Lipoproteins in Lean and Obese Persons
A study testing unsaturated fat for saturated fat and saturated fat in people with Cardiovascular Disease and Dietary Modification, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Dietary Modification, Cardiovascular Risk Factors
- What is being tested?
- unsaturated fat for saturated fat and saturated fat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2016to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- unsaturated fat for saturated fat, saturated fat
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unsaturated fat for saturated fatOther
Substituting unsaturated fat for saturated fat
saturated fatOther
a control diet with whole fat dairy and meat with saturated fats that are not fat reduced
| Study group | Role | What they receive |
|---|---|---|
| unsaturated fat | Experimental | an intervention diet substituting unsaturated fats from oil and nuts for saturated fats from meat and dairy foods Receives: Other: unsaturated fat for saturated fat |
| saturated fat | Active comparator | a control diet with whole fat dairy and meat with saturated fats that are not fat reduced. Receives: Other: saturated fat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 weeks
Secondary outcomes (3)
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
Measured: 10 weeks
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
Measured: 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
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startSep 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tine Mejlbo Sundfør, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589769
- Sponsor's protocol ID
- 1786 (REK(
- Status last verified
- Sep 2016
- First submitted
- 16 Jun 2015
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31216575
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Reduction in Saturated Fat on Cholesterol and Lipoproteins in Lean and Obese Persons
- ClinicalTrials.gov ID
- NCT02589769
- Acronym / sponsor ID
- 1786 (REK(
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 28 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| unsaturated fat | Experimental | Other: unsaturated fat for saturated fatan intervention diet substituting unsaturated fats from oil and nuts for saturated fats from meat and dairy foods |
| saturated fat | Active comparator | Other: saturated fata control diet with whole fat dairy and meat with saturated fats that are not fat reduced. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| unsaturated fat for saturated fatSubstituting unsaturated fat for saturated fat | Other | unsaturated fat |
| saturated fata control diet with whole fat dairy and meat with saturated fats that are not fat reduced | Other | saturated fat |
Primary outcome
Serum lipids in normal weight and obese subjects with elevated LDL cholesterol.
Time frame: 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.
3 secondary outcomes
C-reactive protein in normal weight and obese individuals
Time frame: 10 weeks
Serum PCSK9 in normal weight and obese individuals
Time frame: 10 weeks
Fasting glucose and HbA1C
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Derived from this study: PubMed 31216575Sundfor 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing unsaturated fat for saturated fat and saturated fat in people with Cardiovascular Disease and Dietary Modification, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum lipids in normal weight and obese subjects with elevated LDL cholesterol. (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02589769, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.