Postprandial PeriodNCT01618071
Vascular Effects of Triglyceride-rich Lipoproteins
A study testing High-fat meals varying in their fatty acid composition in people with Postprandial Period and Lipemia, run by King's College London at 1 site in United Kingdom.
Trial summary
Many types of cardiovascular disease begin when the layer of cells lining blood vessels (endothelial cells) start to function abnormally. This causes white blood cells (monocytes) to enter the blood vessel wall and eventually form lesions. Read more about this study
- Who is it for?
- Ages 35 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Postprandial Period, Lipemia, Vasodilation
- What is being tested?
- High-fat meals varying in their fatty acid composition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2012to Oct 2012
- 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 35 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males
- Non-smokers
- Aged 35-70 years
- Fasting TAG concentrations ≥1.2 mmol/L.
Who cannot join
- Reported history of CVD (myocardial infarction, angina, venous thrombosis, stroke), impaired fasting glucose/uncontrolled type 2 diabetes (or fasting glucose ≥ 6.1 mmol/L), cancer, kidney, liver or bowel disease.
- Presence of gastrointestinal disorder or use of drug, which is likely to alter gastrointestinal motility or nutrient absorption.
- History of substance abuse or alcoholism (previous weekly alcohol intake >60 units/men)
- Current self-reported weekly alcohol intake exceeding 28 units
- Allergy or intolerance to any component of test meals
- Unwilling to restrict consumption of any source of fish oil for the length of the study
Show all 11Show fewer
- Weight change of >3kg in preceding 2 months
- Body Mass Index <20 and >35 kg/m2
- Fasting blood cholesterol > 7.8 mmol/L
- Current cigarette smoker.
- Current use of lipid lowering medication
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Diabetes & Nutritional Sciences Division, King's College London
London, SE1 9NH
About this study
Official title: Unravelling the Mechanisms of Vascular Protection by n3-PUFAs to Optimise and Support Their Use as Bioactives by the Food Industry
Many types of cardiovascular disease begin when the layer of cells lining blood vessels (endothelial cells) start to function abnormally. This causes white blood cells (monocytes) to enter the blood vessel wall and eventually form lesions. Fats from foods we consume are carried in the blood for 3-8 hours after a fatty meal in small particles known as chylomicrons (CM) and chylomicron remnants (CMR). The overall aim of this project is to investigate the idea that n-3 polyunsaturated fatty acids (PUFA) protect against heart disease by modifying the effect of CMR on endothelial cells and monocytes. We hypothesize that n3-PUFA carried in CMR reduce detrimental events which promote blood vessel damage and activate protective mechanisms to improve the function of arteries.
- Conditions
- Postprandial Period, Lipemia, Vasodilation, Vascular Resistance, Nitric Oxide
- Being tested
- High-fat meals varying in their fatty acid composition
- Keywords
- n-3 PUFA, Endothelial cells, Nitric oxide, Oxidative stress, Blood pressure, Vasodilation, Lipemia, Unsaturated dietary fats
- Medical subject headings
- Hyperlipidemias, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-fat meals varying in their fatty acid compositionDietary supplement
Also called DHASCO, Purified fish oil
70 g fat incorporated into a muffin and milkshake meal, consumed following fasting baseline measurements
| Study group | Role | What they receive |
|---|---|---|
| Oleic acid | Active comparator | 75 g high oleic acid sunflower oil. Receives: Dietary Supplement: High-fat meals varying in their fatty acid composition |
| Linoleic acid | Active comparator | 75 g high linoleic acid sunflower oil. Receives: Dietary Supplement: High-fat meals varying in their fatty acid composition |
| Eicosapentaenoic acid and docosahexaenoic acid | Experimental | 5 g EPA and DHA derived from fish oil, made up to a total of 75 g with high oleic sunflower oil. Receives: Dietary Supplement: High-fat meals varying in their fatty acid composition |
| Docosahexaenoic acid | Experimental | 5 g DHA derived from algal oil, made up to a total of 75 g with high oleic sunflower oil. Receives: Dietary Supplement: High-fat meals varying in their fatty acid composition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activation of inflammatory/oxidative stress pathways within cultured endothelial cells following treatment with 6 h postprandial chylomicron remnant-rich lipoprotein fraction
The primary outcome of the study is activation of inflammatory/oxidative stress pathways within cultured endothelial cells following incubation with pooled postprandial lipoprotein fractions rich in chylomicron remnants. Due to the nature of this type of research this necessitates more than one primary outcome measure: the primary measures are NF-kappa-beta activation, cytokine production (e.g. interleukin-6) and reactive oxygen species generation in the cultured human endothelial cells.
Measured: 6 h post-meal
Secondary outcomes (14)
Incremental area under the plasma concentration versus time curve (iAUC) of triacylglycerol
Measured: 0, 1, 2, 3, 4, 5 and 6 h post-meal
Incremental area under the plasma concentration versus time curve (iAUC) of glucose
Measured: 0, 1, 2, 3, 4, 5 and 6 h post-meal
Incremental area under the plasma concentration versus time curve (iAUC) for non-esterified fatty acids
Measured: 0, 1, 2, 3, 4, 5 and 6 h post-meal
Incremental area under the plasma concentration versus time curve (iAUC) for plasma fatty acid composition (%)
Measured: 0, 1, 2, 3, 4, 5 and 6 h post-meal
Incremental area under the plasma concentration versus time curve (iAUC) for cholesterol
Measured: 0, 1, 2, 3, 4, 5 and 6 h post-meal
Incremental area under the unit measure versus time curve for brachial augmentation index
Measured: 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min post-meal
Incremental area under the unit measure versus time curve for systolic blood pressure
Measured: 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min post-meal
Incremental area under the unit measure versus time curve for diastolic blood pressure
Measured: 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min post-meal
Change in digital volume pulse stiffness index
Measured: 0, 2, 4 and 6 h post-meal
Change in digital volume pulse reflection index
Measured: 0, 2, 4 and 6 h post-meal
Change in plasma nitrite/nitrate concentrations
Measured: 0, 2, 4 and 6 h
Change in plasma 8-isoprostane F2alpha concentrations
Measured: 0, 2, 4 and 6 h post-meal
Activation of inflammatory/oxidative stress pathways within cultured endothelial cells following treatment with 4 h postprandial chylomicron remnant-rich lipoprotein fraction
Measured: 4 h post-meal
Activation of inflammatory/oxidative stress pathways within cultured endothelial cells following treatment with 5 h postprandial chylomicron remnant-rich lipoprotein fraction
Measured: 5 h post-meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Postprandial PeriodStudies of the same condition, open and under way.
- More trials run by King's College LondonThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Veterinary College
- Responsible party
- Principal investigator, Dr Wendy Hall, King's College London
- Investigators
- Wendy L Hall, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618071
- Sponsor's protocol ID
- DRINC 11-LO-0116
- Other IDs
- BB/1005862/1
- Status last verified
- Sep 2019
- First submitted
- 8 Jun 2012
- Last updated
- 16 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Lambert MS, Botham KM, Mayes PA. Modification of the fatty acid composition of dietary oils and fats on incorporation into chylomicrons and chylomicron remnants. Br J Nutr. 1996 Sep;76(3):435-45. doi: 10.1079/bjn19960048.
PubMed 8881715Botham KM, Bravo E, Elliott J, Wheeler-Jones CP. Direct interaction of dietary lipids carried in chylomicron remnants with cells of the artery wall: implications for atherosclerosis development. Curr Pharm Des. 2005;11(28):3681-95. doi: 10.2174/138161205774580732.
PubMed 16305504Proctor SD, Vine DF, Mamo JC. Arterial retention of apolipoprotein B(48)- and B(100)-containing lipoproteins in atherogenesis. Curr Opin Lipidol. 2002 Oct;13(5):461-70. doi: 10.1097/00041433-200210000-00001.
PubMed 12352009Marcoux C, Hopkins PN, Wang T, Leary ET, Nakajima K, Davignon J, Cohn JS. Remnant-like particle cholesterol and triglyceride levels of hypertriglyceridemic patients in the fed and fasted state. J Lipid Res. 2000 Sep;41(9):1428-36.
PubMed 10974050Hall WL, Sanders KA, Sanders TA, Chowienczyk PJ. A high-fat meal enriched with eicosapentaenoic acid reduces postprandial arterial stiffness measured by digital volume pulse analysis in healthy men. J Nutr. 2008 Feb;138(2):287-91. doi: 10.1093/jn/138.2.287.
PubMed 18203893Burdge GC, Powell J, Dadd T, Talbot D, Civil J, Calder PC. Acute consumption of fish oil improves postprandial VLDL profiles in healthy men aged 50-65 years. Br J Nutr. 2009 Jul;102(1):160-5. doi: 10.1017/S0007114508143550. Epub 2009 Jan 13.
PubMed 19138437Zampelas A, Peel AS, Gould BJ, Wright J, Williams CM. Polyunsaturated fatty acids of the n-6 and n-3 series: effects on postprandial lipid and apolipoprotein levels in healthy men. Eur J Clin Nutr. 1994 Dec;48(12):842-8.
PubMed 7889892Armah CK, Jackson KG, Doman I, James L, Cheghani F, Minihane AM. Fish oil fatty acids improve postprandial vascular reactivity in healthy men. Clin Sci (Lond). 2008 Jun;114(11):679-86. doi: 10.1042/CS20070277.
PubMed 18052925Rontoyanni VG, Hall WL, Pombo-Rodrigues S, Appleton A, Chung R, Sanders TA. A comparison of the changes in cardiac output and systemic vascular resistance during exercise following high-fat meals containing DHA or EPA. Br J Nutr. 2012 Aug;108(3):492-9. doi: 10.1017/S0007114511005721. Epub 2012 Feb 21.
PubMed 22348439Purcell R, Latham SH, Botham KM, Hall WL, Wheeler-Jones CP. High-fat meals rich in EPA plus DHA compared with DHA only have differential effects on postprandial lipemia and plasma 8-isoprostane F2alpha concentrations relative to a control high-oleic acid meal: a randomized controlled trial. Am J Clin Nutr. 2014 Oct;100(4):1019-28. doi: 10.3945/ajcn.114.091223. Epub 2014 Aug 6.
PubMed 25099540
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unravelling the Mechanisms of Vascular Protection by n3-PUFAs to Optimise and Support Their Use as Bioactives by the Food Industry
- ClinicalTrials.gov ID
- NCT01618071
- Acronym / sponsor ID
- DRINC 11-LO-0116
- Conditions
- Postprandial Period, Lipemia, Vasodilation, Vascular Resistance, Nitric Oxide
- Keywords
- n-3 PUFA, Endothelial cells, Nitric oxide, Oxidative stress, Blood pressure, Vasodilation, Lipemia, Unsaturated dietary fats
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Royal Veterinary College
- Study start
- Jun 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 13 Jun 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.
Many types of cardiovascular disease begin when the layer of cells lining blood vessels (endothelial cells) start to function abnormally. This causes white blood cells (monocytes) to enter the blood vessel wall and eventually form lesions. Fats from foods we consume are carried in the blood for 3-8 hours after a fatty meal in small particles known as chylomicrons (CM) and chylomicron remnants (CMR). The overall aim of this project is to investigate the idea that n-3 polyunsaturated fatty acids (PUFA) protect against heart disease by modifying the effect of CMR on endothelial cells and monocytes. We hypothesize that n3-PUFA carried in CMR reduce detrimental events which promote blood vessel damage and activate protective mechanisms to improve the function of arteries.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oleic acid | Active comparator | Dietary Supplement: High-fat meals varying in their fatty acid composition75 g high oleic acid sunflower oil. |
| Linoleic acid | Active comparator | Dietary Supplement: High-fat meals varying in their fatty acid composition75 g high linoleic acid sunflower oil. |
| Eicosapentaenoic acid and docosahexaenoic acid | Experimental | Dietary Supplement: High-fat meals varying in their fatty acid composition5 g EPA and DHA derived from fish oil, made up to a total of 75 g with high oleic sunflower oil. |
| Docosahexaenoic acid | Experimental | Dietary Supplement: High-fat meals varying in their fatty acid composition5 g DHA derived from algal oil, made up to a total of 75 g with high oleic sunflower oil. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy males
- Non-smokers
- Aged 35-70 years
- Fasting TAG concentrations ≥1.2 mmol/L.
Key exclusion criteria (11 listed)
- Reported history of CVD (myocardial infarction, angina, venous thrombosis, stroke), impaired fasting glucose/uncontrolled type 2 diabetes (or fasting glucose ≥ 6.1 mmol/L), cancer, kidney, liver or bowel disease.
- Presence of gastrointestinal disorder or use of drug, which is likely to alter gastrointestinal motility or nutrient absorption.
- History of substance abuse or alcoholism (previous weekly alcohol intake >60 units/men)
- Current self-reported weekly alcohol intake exceeding 28 units
- Allergy or intolerance to any component of test meals
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-fat meals varying in their fatty acid compositionAlso: DHASCO, Purified fish oil70 g fat incorporated into a muffin and milkshake meal, consumed following fasting baseline measurements | Dietary supplement | Docosahexaenoic acid, Eicosapentaenoic acid and docosahexaenoic acid, Linoleic acid, Oleic acid |
Primary outcome
Activation of inflammatory/oxidative stress pathways within cultured endothelial cells following treatment with 6 h postprandial chylomicron remnant-rich lipoprotein fraction
Time frame: 6 h post-meal
The primary outcome of the study is activation of inflammatory/oxidative stress pathways within cultured endothelial cells following incubation with pooled postprandial lipoprotein fractions rich in chylomicron remnants. Due to the nature of this type of research this necessitates more than one primary outcome measure: the primary measures are NF-kappa-beta activation, cytokine production (e.g. interleukin-6) and reactive oxygen species generation in the cultured human endothelial cells.
14 secondary outcomes
Incremental area under the plasma concentration versus time curve (iAUC) of triacylglycerol
Time frame: 0, 1, 2, 3, 4, 5 and 6 h post-meal
Incremental area under the plasma concentration versus time curve (iAUC) of glucose
Time frame: 0, 1, 2, 3, 4, 5 and 6 h post-meal
Incremental area under the plasma concentration versus time curve (iAUC) for non-esterified fatty acids
Time frame: 0, 1, 2, 3, 4, 5 and 6 h post-meal
Incremental area under the plasma concentration versus time curve (iAUC) for plasma fatty acid composition (%)
Time frame: 0, 1, 2, 3, 4, 5 and 6 h post-meal
Incremental area under the plasma concentration versus time curve (iAUC) for cholesterol
Time frame: 0, 1, 2, 3, 4, 5 and 6 h post-meal
Incremental area under the unit measure versus time curve for brachial augmentation index
Time frame: 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min post-meal
Incremental area under the unit measure versus time curve for systolic blood pressure
Time frame: 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min post-meal
Incremental area under the unit measure versus time curve for diastolic blood pressure
Time frame: 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min post-meal
Change in digital volume pulse stiffness index
Time frame: 0, 2, 4 and 6 h post-meal
Change in digital volume pulse reflection index
Time frame: 0, 2, 4 and 6 h post-meal
Change in plasma nitrite/nitrate concentrations
Time frame: 0, 2, 4 and 6 h
Change in plasma 8-isoprostane F2alpha concentrations
Time frame: 0, 2, 4 and 6 h post-meal
Activation of inflammatory/oxidative stress pathways within cultured endothelial cells following treatment with 4 h postprandial chylomicron remnant-rich lipoprotein fraction
Time frame: 4 h post-meal
Activation of inflammatory/oxidative stress pathways within cultured endothelial cells following treatment with 5 h postprandial chylomicron remnant-rich lipoprotein fraction
Time frame: 5 h post-meal
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 16 Sep 2019.
- Background: PubMed 8881715Lambert MS, Botham KM, Mayes PA. Modification of the fatty acid composition of dietary oils and fats on incorporation into chylomicrons and chylomicron remnants. Br J Nutr. 1996 Sep;76(3):435-45. doi: 10.1079/bjn19960048.
- Background: PubMed 16305504Botham KM, Bravo E, Elliott J, Wheeler-Jones CP. Direct interaction of dietary lipids carried in chylomicron remnants with cells of the artery wall: implications for atherosclerosis development. Curr Pharm Des. 2005;11(28):3681-95. doi: 10.2174/138161205774580732.
- Background: PubMed 12352009Proctor SD, Vine DF, Mamo JC. Arterial retention of apolipoprotein B(48)- and B(100)-containing lipoproteins in atherogenesis. Curr Opin Lipidol. 2002 Oct;13(5):461-70. doi: 10.1097/00041433-200210000-00001.
- Background: PubMed 10974050Marcoux C, Hopkins PN, Wang T, Leary ET, Nakajima K, Davignon J, Cohn JS. Remnant-like particle cholesterol and triglyceride levels of hypertriglyceridemic patients in the fed and fasted state. J Lipid Res. 2000 Sep;41(9):1428-36.
- Background: PubMed 18203893Hall WL, Sanders KA, Sanders TA, Chowienczyk PJ. A high-fat meal enriched with eicosapentaenoic acid reduces postprandial arterial stiffness measured by digital volume pulse analysis in healthy men. J Nutr. 2008 Feb;138(2):287-91. doi: 10.1093/jn/138.2.287.
- Background: PubMed 19138437Burdge GC, Powell J, Dadd T, Talbot D, Civil J, Calder PC. Acute consumption of fish oil improves postprandial VLDL profiles in healthy men aged 50-65 years. Br J Nutr. 2009 Jul;102(1):160-5. doi: 10.1017/S0007114508143550. Epub 2009 Jan 13.
- Background: PubMed 7889892Zampelas A, Peel AS, Gould BJ, Wright J, Williams CM. Polyunsaturated fatty acids of the n-6 and n-3 series: effects on postprandial lipid and apolipoprotein levels in healthy men. Eur J Clin Nutr. 1994 Dec;48(12):842-8.
- Background: PubMed 18052925Armah CK, Jackson KG, Doman I, James L, Cheghani F, Minihane AM. Fish oil fatty acids improve postprandial vascular reactivity in healthy men. Clin Sci (Lond). 2008 Jun;114(11):679-86. doi: 10.1042/CS20070277.
- Background: PubMed 22348439Rontoyanni VG, Hall WL, Pombo-Rodrigues S, Appleton A, Chung R, Sanders TA. A comparison of the changes in cardiac output and systemic vascular resistance during exercise following high-fat meals containing DHA or EPA. Br J Nutr. 2012 Aug;108(3):492-9. doi: 10.1017/S0007114511005721. Epub 2012 Feb 21.
- Derived from this study: PubMed 25099540Purcell R, Latham SH, Botham KM, Hall WL, Wheeler-Jones CP. High-fat meals rich in EPA plus DHA compared with DHA only have differential effects on postprandial lipemia and plasma 8-isoprostane F2alpha concentrations relative to a control high-oleic acid meal: a randomized controlled trial. Am J Clin Nutr. 2014 Oct;100(4):1019-28. doi: 10.3945/ajcn.114.091223. Epub 2014 Aug 6.
- Related InfoLink provided by the sponsor.
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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.
Wendy L Hall, PhD principal investigator
King's College London
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-fat meals varying in their fatty acid composition in people with Postprandial Period and Lipemia, run by King's College London 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 11 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 16 Sep 2019. 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?
Activation of inflammatory/oxidative stress pathways within cultured endothelial cells following treatment with 6 h postprandial chylomicron remnant-rich lipoprotein fraction (time frame: 6 h post-meal). 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 NCT01618071, which also lists 10 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 16 Sep 2019.