HypercholesterolemiaRESETNCT02089035
Replacement of Saturated Fat in Dairy on Total Cholesterol
A study testing MUFA-rich dairy products (UHT milk, cheese and butter) and Conventional dairy products (UHT milk, cheese, butter) in people with Hypercholesterolemia, run by University of Reading at 1 site in United Kingdom.
Trial summary
The consumption of milk and dairy products is recognised as an essential part of a healthy diet as it represents an important source of key micro- and macronutrients. Nevertheless, there is still a widespread conviction that the overall high energy density and concentration of long-chain saturated fatty acids (SFA)… Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- MUFA-rich dairy products (UHT milk, cheese and butter) and Conventional dairy products (UHT milk, cheese, butter)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2014to Apr 2016
- 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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mildly hypercholesterolemic: TC <5.2 and <8mmol/L
- Age: 25-70
- BMI: 19-32 kg/m2
- Haemoglobin: >125g/L for women and 135g/L for men
- Normal liver and kidney function
Who cannot join
- Milk, cheese, butter, lactose allergy
- Drug treatment for hyperlipidaemia, hypertension, inflammation and hypercoagulation
- Suffered myocardial infarction/stroke in the past 12months
- Diabetic (diagnosed or fasting glucose > 7 mmol/l) or suffer from other endocrine disorders
- Surgery in the previous 6 months
- Excessive alcohol consumption (>28 unit/wk man; >21 unit/wk women)
Show all 15Show fewer
- Taking vitamin, mineral or fatty acid supplements (e.g. fish oil, calcium)
- Pregnant, lactating, planning a pregnancy or not using effective contraceptive precautions
- Smokers
- Vegans
- Anaemic
- Planning or on a weight reduction scheme
- Parallel participation in another intervention study
- Participating in intensive aerobic activity for > 20 minutes 3 times per week
- Use of anti-inflammatory medication
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Food and Nutritional Sciences, University of Reading
Reading, Berks, RG6 6AP
About this study
Official title: Replacement of Saturated Fat in Dairy on Total Cholesterol, Vascular Function, Ambulatory Blood Pressure and Cardiovascular Risk Biomarkers
The consumption of milk and dairy products is recognised as an essential part of a healthy diet as it represents an important source of key micro- and macronutrients. Nevertheless, there is still a widespread conviction that the overall high energy density and concentration of long-chain saturated fatty acids (SFA) present in dairy have detrimental health effects, contributing to the progression of cardiovascular disease, obesity and diabetes.
Supplementation of the bovine diet with a source of MUFA, such as rapesee oil, has become an achievable strategy in order to reduce the amount of SFA present in dairy products.
The aim of this project is to observe the effects of three types of dairy products (UHT milk, cheese and butter) produced from milk derived from cows fed withhigh-oleic sunflower oil, on CVD risk biomarkers and plasma total cholesterol levels in adults with an increased risk of developing CVD. The aim is to determine whether an isoenergetic exchange of dairy products will affect vascular function and CVD biomarkers.
- Conditions
- Hypercholesterolemia
- Being tested
- MUFA-rich dairy products (UHT milk, cheese and butter), Conventional dairy products (UHT milk, cheese, butter)
- Keywords
- Milk fatty acids, Total cholesterol, Vascular function, Blood pressure
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MUFA-rich dairy products (UHT milk, cheese and butter)Dietary supplement
Conventional dairy products (UHT milk, cheese, butter)Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| MUFA-rich dairy products | Experimental | Subjects are asked to exchange habitual dairy products for modified MUFA-rich experimental dairy products for a 12 week period.
Participants will provided with standardised quantities of pasteurised UHT milk, cheese and butter that they will be asked to consume on a daily basis. Receives: Dietary Supplement: MUFA-rich dairy products (UHT milk, cheese and butter) |
| Conventional dairy products | Experimental | Subjects are asked to consume habitual non-modified dairy products for a period of 12 weeks.
Participants will provided with standardised quantities of pasteurised UHT milk, cheese and butter that they will be asked to consume on a daily basis. Receives: Dietary Supplement: Conventional dairy products (UHT milk, cheese, butter) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic study: Changes in fasting plasma circulating levels of total cholesterol
Measured: Chronic study: Baseline and week 12 for both intervention arms
Acute study: Changes in postprandial flow-mediated dilatation
Measured: Acute study: 0, 180, 300 and 420 min at baseline and week 12 for both intervention arms
Secondary outcomes (13)
Changes in vascular stiffness by Carotid Intima Media Thickness (CIMT)
Measured: Chronic study: Baseline measurements (0min) for both intervention arms
Change in 24-hour ambulatory blood pressure
Measured: Chronic study: baseline (-1week) and week 11, 19 and 31 for 24 hours. Measurements will be recorded every 30min (7am to 10pm) and every hour (10pm-7am)
Changes in plasma circulating markers of vascular health
Measured: Chronic study: Baseline and week 12 for both intervention arms. Acute study: area under the curve from 0-8 h after consumption of breakfast (0 min) and lunch (330 min) for both intervention arms
Changes in plasma circulating markers of inflammatory status
Measured: Chronic study: Baseline and week 12 for both intervention arms. Acute study: area under the curve from 0-8 h after consumption of breakfast (0 min) and lunch (330 min) for both intervention arms
Changes in plasma circulating markers related to lipid metabolism
Measured: Chronic study: Baseline and week 12 for both intervention arms. Acute study: area under the curve from 0-8 h after consumption of breakfast (0 min) and lunch (330 min) for both intervention arms
Changes in plasma circulating markers related to insulin resistance
Measured: Chronic study: Baseline and week 12 for both intervention arms. Acute study: area under the curve from 0-8 h after consumption of breakfast (0 min) and lunch (330 min) for both intervention arms
Changes in vascular stiffness by Pulse Wave Velocity (PWV)
Measured: Chronic study: Baseline (0 min) and week 12 for both intervention arms
Changes in vascular stiffness by Pulse Wave Analysis (PWA)
Measured: Chronic study: Baseline (0 min) and week 12 for both intervention arms
Changes in vascular stiffness by Digital Volume Pulse (DVP)
Measured: Chronic study: Baseline (0 min) and week 12 for both intervention arms
Changes in monocytic cytokine production from whole blood culture
Measured: Chronic and acute study: Baseline and week 12 for both intervention arms. Acute: area under the curve from 0-8 h following consumption of breakfast (0 min) and lunch (330 min) for both intervention arms
Changes in vascular reactivity by Flow Mediated Dilatation (FMD)
Measured: Chronic study: Baseline and assessment at 12 weeks for each intervention arm.
Changes in anthropometric measurements
Measured: Chronic study: Baseline and assessment at 12 weeks for each intervention arm.
Change in plasma phospholipid fatty acid composition
Measured: Chronic and acute study: Baseline and week 12 for both intervention arms. Acute study: 0, 180, 300 and 420 min at baseline and week 12 for both intervention arms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council
- Responsible party
- Principal investigator, Julie Lovegrove, University of Reading
- Investigators
- Julie A. Lovegrove, BSc, PhD, RNutr, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02089035
- Sponsor's protocol ID
- 13/43
- Other IDs
- University of Reading
- Acronym
- RESET
- Status last verified
- May 2016
- First submitted
- 5 Jan 2014
- Last updated
- 24 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Livingstone KM, Lovegrove JA, Givens DI. The impact of substituting SFA in dairy products with MUFA or PUFA on CVD risk: evidence from human intervention studies. Nutr Res Rev. 2012 Dec;25(2):193-206. doi: 10.1017/S095442241200011X. Epub 2012 Aug 6.
PubMed 22863409Elwood PC, Pickering JE, Givens DI, Gallacher JE. The consumption of milk and dairy foods and the incidence of vascular disease and diabetes: an overview of the evidence. Lipids. 2010 Oct;45(10):925-39. doi: 10.1007/s11745-010-3412-5. Epub 2010 Apr 16.
PubMed 20397059Markey O, Vasilopoulou D, Kliem KE, Fagan CC, Grandison AS, Sutton R, Humphries DJ, Todd S, Jackson KG, Givens DI, Lovegrove JA. Postprandial Fatty Acid Profile, but Not Cardiometabolic Risk Markers, Is Modulated by Dairy Fat Manipulation in Adults with Moderate Cardiovascular Disease Risk: The Randomized Controlled REplacement of SaturatEd fat in dairy on Total cholesterol (RESET) Study. J Nutr. 2021 Jul 1;151(7):1755-1768. doi: 10.1093/jn/nxab050.
PubMed 33758921Vasilopoulou D, Markey O, Kliem KE, Fagan CC, Grandison AS, Humphries DJ, Todd S, Jackson KG, Givens DI, Lovegrove JA. Reformulation initiative for partial replacement of saturated with unsaturated fats in dairy foods attenuates the increase in LDL cholesterol and improves flow-mediated dilatation compared with conventional dairy: the randomized, controlled REplacement of SaturatEd fat in dairy on Total cholesterol (RESET) study. Am J Clin Nutr. 2020 Apr 1;111(4):739-748. doi: 10.1093/ajcn/nqz344.
PubMed 32020168Markey O, Vasilopoulou D, Kliem KE, Koulman A, Fagan CC, Summerhill K, Wang LY, Grandison AS, Humphries DJ, Todd S, Jackson KG, Givens DI, Lovegrove JA. Plasma phospholipid fatty acid profile confirms compliance to a novel saturated fat-reduced, monounsaturated fat-enriched dairy product intervention in adults at moderate cardiovascular risk: a randomized controlled trial. Nutr J. 2017 May 23;16(1):33. doi: 10.1186/s12937-017-0249-2.
PubMed 28535777
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Replacement of Saturated Fat in Dairy on Total Cholesterol, Vascular Function, Ambulatory Blood Pressure and Cardiovascular Risk Biomarkers
- ClinicalTrials.gov ID
- NCT02089035
- Acronym / sponsor ID
- RESET / 13/43
- Conditions
- Hypercholesterolemia
- Keywords
- Milk fatty acids, Total cholesterol, Vascular function, Blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- Medical Research Council
- Study start
- May 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 17 Mar 2014 (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.
The consumption of milk and dairy products is recognised as an essential part of a healthy diet as it represents an important source of key micro- and macronutrients. Nevertheless, there is still a widespread conviction that the overall high energy density and concentration of long-chain saturated fatty acids (SFA) present in dairy have detrimental health effects, contributing to the progression of cardiovascular disease, obesity and diabetes.
Supplementation of the bovine diet with a source of MUFA, such as rapesee oil, has become an achievable strategy in order to reduce the amount of SFA present in dairy products.
The aim of this project is to observe the effects of three types of dairy products (UHT milk, cheese and butter) produced from milk derived from cows fed withhigh-oleic sunflower oil, on CVD risk biomarkers and plasma total cholesterol levels in adults with an increased risk of developing CVD. The aim is to determine whether an isoenergetic exchange of dairy products will affect vascular function and CVD biomarkers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MUFA-rich dairy products | Experimental | Dietary Supplement: MUFA-rich dairy products (UHT milk, cheese and butter)Subjects are asked to exchange habitual dairy products for modified MUFA-rich experimental dairy products for a 12 week period. Participants will provided with standardised quantities of pasteurised UHT milk, cheese and butter that they will be asked to consume on a daily basis. |
| Conventional dairy products | Experimental | Dietary Supplement: Conventional dairy products (UHT milk, cheese, butter)Subjects are asked to consume habitual non-modified dairy products for a period of 12 weeks. Participants will provided with standardised quantities of pasteurised UHT milk, cheese and butter that they will be asked to consume on a daily basis. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Mildly hypercholesterolemic: TC <5.2 and <8mmol/L
- Age: 25-70
- BMI: 19-32 kg/m2
- Haemoglobin: >125g/L for women and 135g/L for men
- Normal liver and kidney function
Key exclusion criteria (15 listed)
- Milk, cheese, butter, lactose allergy
- Drug treatment for hyperlipidaemia, hypertension, inflammation and hypercoagulation
- Suffered myocardial infarction/stroke in the past 12months
- Diabetic (diagnosed or fasting glucose > 7 mmol/l) or suffer from other endocrine disorders
- Surgery in the previous 6 months
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 |
|---|---|---|
| MUFA-rich dairy products (UHT milk, cheese and butter) | Dietary supplement | MUFA-rich dairy products |
| Conventional dairy products (UHT milk, cheese, butter) | Dietary supplement | Conventional dairy products |
Primary outcome
Chronic study: Changes in fasting plasma circulating levels of total cholesterol
Time frame: Chronic study: Baseline and week 12 for both intervention arms
Acute study: Changes in postprandial flow-mediated dilatation
Time frame: Acute study: 0, 180, 300 and 420 min at baseline and week 12 for both intervention arms
13 secondary outcomes
Changes in vascular stiffness by Carotid Intima Media Thickness (CIMT)
Time frame: Chronic study: Baseline measurements (0min) for both intervention arms
Change in 24-hour ambulatory blood pressure
Time frame: Chronic study: baseline (-1week) and week 11, 19 and 31 for 24 hours. Measurements will be recorded every 30min (7am to 10pm) and every hour (10pm-7am)
Changes in plasma circulating markers of vascular health
Time frame: Chronic study: Baseline and week 12 for both intervention arms. Acute study: area under the curve from 0-8 h after consumption of breakfast (0 min) and lunch (330 min) for both intervention arms
Changes in plasma circulating markers of inflammatory status
Time frame: Chronic study: Baseline and week 12 for both intervention arms. Acute study: area under the curve from 0-8 h after consumption of breakfast (0 min) and lunch (330 min) for both intervention arms
Changes in plasma circulating markers related to lipid metabolism
Time frame: Chronic study: Baseline and week 12 for both intervention arms. Acute study: area under the curve from 0-8 h after consumption of breakfast (0 min) and lunch (330 min) for both intervention arms
Changes in plasma circulating markers related to insulin resistance
Time frame: Chronic study: Baseline and week 12 for both intervention arms. Acute study: area under the curve from 0-8 h after consumption of breakfast (0 min) and lunch (330 min) for both intervention arms
Changes in vascular stiffness by Pulse Wave Velocity (PWV)
Time frame: Chronic study: Baseline (0 min) and week 12 for both intervention arms
Changes in vascular stiffness by Pulse Wave Analysis (PWA)
Time frame: Chronic study: Baseline (0 min) and week 12 for both intervention arms
Changes in vascular stiffness by Digital Volume Pulse (DVP)
Time frame: Chronic study: Baseline (0 min) and week 12 for both intervention arms
Changes in monocytic cytokine production from whole blood culture
Time frame: Chronic and acute study: Baseline and week 12 for both intervention arms. Acute: area under the curve from 0-8 h following consumption of breakfast (0 min) and lunch (330 min) for both intervention arms
Changes in vascular reactivity by Flow Mediated Dilatation (FMD)
Time frame: Chronic study: Baseline and assessment at 12 weeks for each intervention arm.
Changes in anthropometric measurements
Time frame: Chronic study: Baseline and assessment at 12 weeks for each intervention arm.
Change in plasma phospholipid fatty acid composition
Time frame: Chronic and acute study: Baseline and week 12 for both intervention arms. Acute study: 0, 180, 300 and 420 min at baseline and week 12 for both intervention arms
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 24 Jul 2017.
- Background: PubMed 22863409Livingstone KM, Lovegrove JA, Givens DI. The impact of substituting SFA in dairy products with MUFA or PUFA on CVD risk: evidence from human intervention studies. Nutr Res Rev. 2012 Dec;25(2):193-206. doi: 10.1017/S095442241200011X. Epub 2012 Aug 6.
- Background: PubMed 20397059Elwood PC, Pickering JE, Givens DI, Gallacher JE. The consumption of milk and dairy foods and the incidence of vascular disease and diabetes: an overview of the evidence. Lipids. 2010 Oct;45(10):925-39. doi: 10.1007/s11745-010-3412-5. Epub 2010 Apr 16.
- Derived from this study: PubMed 33758921Markey O, Vasilopoulou D, Kliem KE, Fagan CC, Grandison AS, Sutton R, Humphries DJ, Todd S, Jackson KG, Givens DI, Lovegrove JA. Postprandial Fatty Acid Profile, but Not Cardiometabolic Risk Markers, Is Modulated by Dairy Fat Manipulation in Adults with Moderate Cardiovascular Disease Risk: The Randomized Controlled REplacement of SaturatEd fat in dairy on Total cholesterol (RESET) Study. J Nutr. 2021 Jul 1;151(7):1755-1768. doi: 10.1093/jn/nxab050.
- Derived from this study: PubMed 32020168Vasilopoulou D, Markey O, Kliem KE, Fagan CC, Grandison AS, Humphries DJ, Todd S, Jackson KG, Givens DI, Lovegrove JA. Reformulation initiative for partial replacement of saturated with unsaturated fats in dairy foods attenuates the increase in LDL cholesterol and improves flow-mediated dilatation compared with conventional dairy: the randomized, controlled REplacement of SaturatEd fat in dairy on Total cholesterol (RESET) study. Am J Clin Nutr. 2020 Apr 1;111(4):739-748. doi: 10.1093/ajcn/nqz344.
- Derived from this study: PubMed 28535777Markey O, Vasilopoulou D, Kliem KE, Koulman A, Fagan CC, Summerhill K, Wang LY, Grandison AS, Humphries DJ, Todd S, Jackson KG, Givens DI, Lovegrove JA. Plasma phospholipid fatty acid profile confirms compliance to a novel saturated fat-reduced, monounsaturated fat-enriched dairy product intervention in adults at moderate cardiovascular risk: a randomized controlled trial. Nutr J. 2017 May 23;16(1):33. doi: 10.1186/s12937-017-0249-2.
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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, BSc, PhD, RNutr 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 MUFA-rich dairy products (UHT milk, cheese and butter) and Conventional dairy products (UHT milk, cheese, butter) in people with Hypercholesterolemia, 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 5 inclusion and 15 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 24 Jul 2017. 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?
Chronic study: Changes in fasting plasma circulating levels of total cholesterol (time frame: Chronic study: Baseline and week 12 for both intervention arms). The study lists 2 primary outcomes in all. 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 NCT02089035, which also lists 5 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 24 Jul 2017.