Cardiovascular DiseaseNCT01522482
Apolipoprotein (APO)E Genotype, Meal Fatty Acids, Postprandial Lipaemia
A study testing High saturated fat meal, Saturated fatty acids and fish oil meal and High unsaturated fat meal in people with Cardiovascular Disease, run by University of Reading at 1 site in United Kingdom.
Trial summary
Cardiovascular disease (CVD) is the greatest cause of morbidity and mortality in the UK. Abnormalities in the concentration and/or composition of lipoproteins (the lipid carrying particles), in particular low density lipoproteins (LDL) in circulation, is one of the most important physiological defects contributing to… Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- High saturated fat meal, Saturated fatty acids and fish oil meal and High unsaturated fat meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2009to Jul 2011
- 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 18 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gender Male
- Age 18-70 years
- Body Mass Index (BMI) < 32 kg/m2
- Plasma triglycerides 1-4 mmol/l
- Plasma cholesterol < 8 mmol/l
- Glucose < 7 mmol/l
- Haemoglobin > 11 g/dl
- ApoE E3/E3, E3/E4
Who cannot join
- Blood pressure > 200/95 mmHg
- Had suffered a myocardial infraction or stroke in previous 2 years.
- Diabetes mellitus
- Liver disease
- Other endocrine disorders
- Unstable angina
Show all 12Show fewer
- Familial hyperlipidaemia
- Any dietary restrictions or an a weight reducing diet
- On fatty acid supplements e.g. evening primrose oil or fish oils
- Vigorous exercise e.g. competitive athletes
- ApoE2/E2, apoE2/E3 and apoE2/E4
- Any other parameter on which the investigators felt an individual was unsuitable
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Food and Nutritional Sciences, University of Reading
Reading
About this study
Official title: Effects of Meal Fatty Acid Composition on Postprandial Lipaemia in Men According to APOE Genotype
Cardiovascular disease (CVD) is the greatest cause of morbidity and mortality in the UK. Abnormalities in the concentration and/or composition of lipoproteins (the lipid carrying particles), in particular low density lipoproteins (LDL) in circulation, is one of the most important physiological defects contributing to the development of CVD.
The LDL cholesterol (LDLC) response to fatty acid change is in part mediated by the APOE genotype, with E4 individuals (25% of the UK population) being most responsive to changes in dietary fats, showing greater reductions when low levels of saturated fats or fish oils are consumed and greater increases when high levels of these fats are consumed. Therefore the aims of the present study is to understand the mechanism that regulates the higher LDLC response associated with saturated fatty acids and fish oil consumption in healthy men prospectively recruited based on their APOE genotype.
- Conditions
- Cardiovascular Disease
- Being tested
- High saturated fat meal, Saturated fatty acids and fish oil meal, High unsaturated fat meal
- Keywords
- fatty acids, cardiovascular disease, genotype, apoE
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High saturated fat mealDietary supplement
Volunteers consumed a single test meal breakfast containing 53 g of fat, of which 50 g was substituted for saturated fats.
Saturated fatty acids and fish oil mealDietary supplement
Volunteers consumed a single test meal breakfast containing 53 g of fat, of which 50 g was substituted for saturated fats and fish oil.
The dose of fish oils was equivalent to two portions of oily fish.
High unsaturated fat mealDietary supplement
Volunteers consumed a single test meal breakfast containing 53 g of fat, of which 50 g was substituted for unsaturated fats. It provided a fatty acid profile representative of a typical UK diet.
| Study group | Role | What they receive |
|---|---|---|
| High saturated fat meal | Experimental | Not described Receives: Dietary Supplement: High saturated fat meal |
| Saturated fatty acid and fish oils meal | Experimental | Equivalent to two portions of oily fish Receives: Dietary Supplement: Saturated fatty acids and fish oil meal |
| High unsaturated fat meal | Active comparator | Provided a fatty acid profile representative of a typical UK diet Receives: Dietary Supplement: High unsaturated fat meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of APOE genotype and dietary fat composition in plasma lipids
Measured: 3 months
Secondary outcomes (1)
Cardiovascular disease risk factors
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startMar 2009
- Primary completionDec 2009
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- Unilever R&D
- Responsible party
- Principal investigator, Julie Lovegrove, University of Reading
- Investigators
- Julie A Lovegrove, Professor, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522482
- Sponsor's protocol ID
- 08/31
- Status last verified
- Jan 2012
- First submitted
- 26 Jan 2012
- Last updated
- 2 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Calabuig-Navarro MV, Jackson KG, Kemp CF, Leake DS, Walden CM, Lovegrove JA, Minihane AM. A randomized trial and novel SPR technique identifies altered lipoprotein-LDL receptor binding as a mechanism underlying elevated LDL-cholesterol in APOE4s. Sci Rep. 2017 Mar 9;7:44119. doi: 10.1038/srep44119.
PubMed 28276521Calabuig-Navarro MV, Jackson KG, Walden CM, Minihane AM, Lovegrove JA. Apolipoprotein E genotype has a modest impact on the postprandial plasma response to meals of varying fat composition in healthy men in a randomized controlled trial. J Nutr. 2014 Nov;144(11):1775-80. doi: 10.3945/jn.114.197244. Epub 2014 Sep 17.
PubMed 25332476
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Meal Fatty Acid Composition on Postprandial Lipaemia in Men According to APOE Genotype
- ClinicalTrials.gov ID
- NCT01522482
- Acronym / sponsor ID
- 08/31
- Conditions
- Cardiovascular Disease
- Keywords
- fatty acids, cardiovascular disease, genotype, apoE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- Unilever R&D
- Study start
- Mar 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 31 Jan 2012 (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.
Cardiovascular disease (CVD) is the greatest cause of morbidity and mortality in the UK. Abnormalities in the concentration and/or composition of lipoproteins (the lipid carrying particles), in particular low density lipoproteins (LDL) in circulation, is one of the most important physiological defects contributing to the development of CVD.
The LDL cholesterol (LDLC) response to fatty acid change is in part mediated by the APOE genotype, with E4 individuals (25% of the UK population) being most responsive to changes in dietary fats, showing greater reductions when low levels of saturated fats or fish oils are consumed and greater increases when high levels of these fats are consumed. Therefore the aims of the present study is to understand the mechanism that regulates the higher LDLC response associated with saturated fatty acids and fish oil consumption in healthy men prospectively recruited based on their APOE genotype.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High saturated fat meal | Experimental | Dietary Supplement: High saturated fat meal |
| Saturated fatty acid and fish oils meal | Experimental | Dietary Supplement: Saturated fatty acids and fish oil mealEquivalent to two portions of oily fish |
| High unsaturated fat meal | Active comparator | Dietary Supplement: High unsaturated fat mealProvided a fatty acid profile representative of a typical UK diet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Gender Male
- Age 18-70 years
- Body Mass Index (BMI) < 32 kg/m2
- Plasma triglycerides 1-4 mmol/l
- Plasma cholesterol < 8 mmol/l
Key exclusion criteria (12 listed)
- Blood pressure > 200/95 mmHg
- Had suffered a myocardial infraction or stroke in previous 2 years.
- Diabetes mellitus
- Liver disease
- Other endocrine disorders
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 |
|---|---|---|
| High saturated fat mealVolunteers consumed a single test meal breakfast containing 53 g of fat, of which 50 g was substituted for saturated fats. | Dietary supplement | High saturated fat meal |
| Saturated fatty acids and fish oil mealVolunteers consumed a single test meal breakfast containing 53 g of fat, of which 50 g was substituted for saturated fats and fish oil. The dose of fish oils was equivalent to two portions of oily fish. | Dietary supplement | Saturated fatty acid and fish oils meal |
| High unsaturated fat mealVolunteers consumed a single test meal breakfast containing 53 g of fat, of which 50 g was substituted for unsaturated fats. It provided a fatty acid profile representative of a typical UK diet. | Dietary supplement | High unsaturated fat meal |
Primary outcome
Impact of APOE genotype and dietary fat composition in plasma lipids
Time frame: 3 months
1 secondary outcome
Cardiovascular disease risk factors
Time frame: 3 months
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 2 Feb 2012.
- Derived from this study: PubMed 28276521Calabuig-Navarro MV, Jackson KG, Kemp CF, Leake DS, Walden CM, Lovegrove JA, Minihane AM. A randomized trial and novel SPR technique identifies altered lipoprotein-LDL receptor binding as a mechanism underlying elevated LDL-cholesterol in APOE4s. Sci Rep. 2017 Mar 9;7:44119. doi: 10.1038/srep44119.
- Derived from this study: PubMed 25332476Calabuig-Navarro MV, Jackson KG, Walden CM, Minihane AM, Lovegrove JA. Apolipoprotein E genotype has a modest impact on the postprandial plasma response to meals of varying fat composition in healthy men in a randomized controlled trial. J Nutr. 2014 Nov;144(11):1775-80. doi: 10.3945/jn.114.197244. Epub 2014 Sep 17.
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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.
Julie A Lovegrove, Professor principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High saturated fat meal, Saturated fatty acids and fish oil meal and High unsaturated fat meal in people with Cardiovascular Disease, run by University of Reading at 1 site in United Kingdom.
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 8 inclusion and 12 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 2 Feb 2012. 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 United Kingdom. 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?
Impact of APOE genotype and dietary fat composition in plasma lipids (time frame: 3 months). 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 NCT01522482, which also lists 2 linked publications.
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 2 Feb 2012.