Cardiovascular DiseasesDOCNCT04867629
Impact of Rapeseed and Sunflower Oils on Proteomic Biomarkers of Diseases.
A study testing Rapeseed oil and Sunflower oil in people with Cardiovascular Diseases, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
This study will test the impact of vegetable oils with contrasting fatty acids composition on biomarkers of health (cardiovascular, kidney diseases and diabetes) after twelve weeks supplementation. We will use sunflower oil (high in PUFAs), rapeseed oil (high in MUFAs, locally produced) and a non-intervention control. Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Rapeseed oil and Sunflower oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2015to Feb 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overweight adults with a BMI>25 and/or a large waist (Male >102cm and female >88cm),
- Aged 25-75 years
- No history of chronic disease of the GI tract
- Not taking medication (other than the contraceptive pill).
Who cannot join
- Pregnant or lactating
- Allergy to any vegetable oils and vegetable oil-derived products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: No Evidence of Impact of Seed Oil Intake on Biomarkers of Coronary Artery Disease, Chronic Kidney Disease and Diabetes in Healthy Adults With Overweight and Obesity - Result From a Blinded Randomised Control Trial
This study will test the impact of vegetable oils with contrasting fatty acids composition on biomarkers of health (cardiovascular, kidney diseases and diabetes) after twelve weeks supplementation. We will use sunflower oil (high in PUFAs), rapeseed oil (high in MUFAs, locally produced) and a non-intervention control. We have developed a sensitive and selective urinary proteomic biomarker of cardiovascular disease which we will use in a double-blinded randomised study.
Read the detailed description
The intervention follows a parallel double-blind randomised control design. The intervention duration is 12 weeks, with a mid-point assessment at 6 weeks. Randomisation to groups; rapeseed oil, sunflower oil or habitual diet is performed using a block stratified allocation based on age (under or over 45) and BMI (under or over 30kg/m2) and is carried out remotely via phone.
Participants allocated to either oil groups are instructed to consume the oils uncooked, as a partial replacement to their habitual fat intake. Participants in the control group are asked to not change any aspect of their diet.
Spot urine samples are collected from all participants at all time points for measurement of the primary outcome (proteomic biomarker score). Urine is collected in a plastic tube, mid-flow, as the second urination of the day at baseline, 6 and 12 weeks.
Fasting venous blood is collected for the assessment of secondary outcomes, at baseline, 6 weeks and 12 weeks. Participants are also asked to complete a 2-day food diary at weeks 0, 6 and 12
- Conditions
- Cardiovascular Diseases
- Being tested
- Rapeseed oil, Sunflower oil
- Keywords
- rapeseed oil, sunflower oil, proteomics, cardiometabolic, cardiovascular, fatty acids, monounsaturated fatty acids, seed oils, dietary 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.
Rapeseed oilDietary supplement
Also called RO
20mL of rapeseed oil to be consumed daily in replacement to habitual oil
Sunflower oilDietary supplement
Also called SO
20mL of sunflower oil to be consumed daily in replacement to habitual oil
| Study group | Role | What they receive |
|---|---|---|
| Rapeseed oil | Experimental | Participants asked to consume 20mL of rapeseed oil raw every day for 12 weeks Receives: Dietary Supplement: Rapeseed oil |
| Sunflower oil | Active comparator | Participants asked to consume 20mL of sunflower oil raw every day for 12 weeks Receives: Dietary Supplement: Sunflower oil |
| Habitual diet | No intervention | Participants asked to maintain their habitual diet for 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proteomic biomarkers
Changes in proteomic biomarker scores of coronary artery disease (CAD238), chronic kidney disease (CKD273)
Measured: 0, 6, 12 weeks
Secondary outcomes (3)
Blood lipids
Changes in concentrations of plasma glucose, triglycerides, total cholesterol, high density lipoprotein,
Measured: 0, 6, 12 weeks
Inflammation markers
Changes in concentrations of plasma interleukin 6, tumor necrosis factor, matrix metallopeptidase 9
Measured: 0, 6, 12 weeks
Oxidative stress biomarkers
Changes in concentrations of plasma fructosamine, AGE, RAGE
Measured: 0, 6, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study startJul 2015
- Primary completionFeb 2016
- Study completionFeb 2016
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 DiseasesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, double-blind, placebo-controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emilie Combet, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867629
- Sponsor's protocol ID
- DOC
- Acronym
- DOC
- Status last verified
- Apr 2021
- First submitted
- 27 Apr 2021
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nicol K, Mansoorian B, Latosinska A, Koutroulaki A, Mullen B, Combet E. No evidence of differential impact of sunflower and rapeseed oil on biomarkers of coronary artery disease or chronic kidney disease in healthy adults with overweight and obesity: result from a randomised control trial. Eur J Nutr. 2022 Sep;61(6):3119-3133. doi: 10.1007/s00394-022-02810-5. Epub 2022 Apr 5.
PubMed 35381848
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- No Evidence of Impact of Seed Oil Intake on Biomarkers of Coronary Artery Disease, Chronic Kidney Disease and Diabetes in Healthy Adults With Overweight and Obesity - Result From a Blinded Randomised Control Trial
- ClinicalTrials.gov ID
- NCT04867629
- Acronym / sponsor ID
- DOC / DOC
- Conditions
- Cardiovascular Diseases
- Keywords
- rapeseed oil, sunflower oil, proteomics, cardiometabolic, cardiovascular, fatty acids, monounsaturated fatty acids, seed oils
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 30 Apr 2021 (actual)
- 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.
This study will test the impact of vegetable oils with contrasting fatty acids composition on biomarkers of health (cardiovascular, kidney diseases and diabetes) after twelve weeks supplementation. We will use sunflower oil (high in PUFAs), rapeseed oil (high in MUFAs, locally produced) and a non-intervention control. We have developed a sensitive and selective urinary proteomic biomarker of cardiovascular disease which we will use in a double-blinded randomised study.
Detailed description
The intervention follows a parallel double-blind randomised control design. The intervention duration is 12 weeks, with a mid-point assessment at 6 weeks. Randomisation to groups; rapeseed oil, sunflower oil or habitual diet is performed using a block stratified allocation based on age (under or over 45) and BMI (under or over 30kg/m2) and is carried out remotely via phone.
Participants allocated to either oil groups are instructed to consume the oils uncooked, as a partial replacement to their habitual fat intake. Participants in the control group are asked to not change any aspect of their diet.
Spot urine samples are collected from all participants at all time points for measurement of the primary outcome (proteomic biomarker score). Urine is collected in a plastic tube, mid-flow, as the second urination of the day at baseline, 6 and 12 weeks.
Fasting venous blood is collected for the assessment of secondary outcomes, at baseline, 6 weeks and 12 weeks. Participants are also asked to complete a 2-day food diary at weeks 0, 6 and 12
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- A randomized, double-blind, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Rapeseed oil | Experimental | Dietary Supplement: Rapeseed oilParticipants asked to consume 20mL of rapeseed oil raw every day for 12 weeks |
| Sunflower oil | Active comparator | Dietary Supplement: Sunflower oilParticipants asked to consume 20mL of sunflower oil raw every day for 12 weeks |
| Habitual diet | No intervention | –Participants asked to maintain their habitual diet for 12 weeks |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Overweight adults with a BMI>25 and/or a large waist (Male >102cm and female >88cm),
- Aged 25-75 years
- No history of chronic disease of the GI tract
- Not taking medication (other than the contraceptive pill).
Key exclusion criteria (2 listed)
- Pregnant or lactating
- Allergy to any vegetable oils and vegetable oil-derived products
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 |
|---|---|---|
| Rapeseed oilAlso: RO20mL of rapeseed oil to be consumed daily in replacement to habitual oil | Dietary supplement | Rapeseed oil |
| Sunflower oilAlso: SO20mL of sunflower oil to be consumed daily in replacement to habitual oil | Dietary supplement | Sunflower oil |
Primary outcome
Proteomic biomarkers
Time frame: 0, 6, 12 weeks
Changes in proteomic biomarker scores of coronary artery disease (CAD238), chronic kidney disease (CKD273)
3 secondary outcomes
Blood lipids
Time frame: 0, 6, 12 weeks
Inflammation markers
Time frame: 0, 6, 12 weeks
Oxidative stress biomarkers
Time frame: 0, 6, 12 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 30 Apr 2021.
- Derived from this study: PubMed 35381848Nicol K, Mansoorian B, Latosinska A, Koutroulaki A, Mullen B, Combet E. No evidence of differential impact of sunflower and rapeseed oil on biomarkers of coronary artery disease or chronic kidney disease in healthy adults with overweight and obesity: result from a randomised control trial. Eur J Nutr. 2022 Sep;61(6):3119-3133. doi: 10.1007/s00394-022-02810-5. Epub 2022 Apr 5.
- Individual participant dataSharing planned: No
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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 Rapeseed oil and Sunflower oil in people with Cardiovascular Diseases, run by University of Glasgow 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 4 inclusion and 2 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 30 Apr 2021. 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?
Proteomic biomarkers (time frame: 0, 6, 12 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 NCT04867629, 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 30 Apr 2021.