Risk Factor, CardiovascularNCT03698786
Exercise Effects on Appetite-regulating Hormones and Cardiovascular Risk Factors
An observational study of Risk Factor, Cardiovascular and Physical Activity, run by Kingston University at 1 site in United Kingdom.
Trial summary
The aim of this study is to examine the effect of a single bout of moderate exercise, standardized breakfast and buffet meal on appetite-related hormones, type two diabetes and cardiovascular risk factors with a comparison between healthy South Asian and white European men. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Risk Factor, Cardiovascular, Physical Activity, Pre-diabetes
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 May 2017to 1 Mar 2019
- Phase
- Observational
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: This study will involve a cohort of 15 White European and 15 South Asian (India, Pakistan, Sri Lanka, Nepal, Bangladesh, Maldives and Bhutan), men, between the ages of 18-50 years with no known underlying disease.
Who may be able to join
- Non-smoker
- Non-dieting
- Physically well to participant in maximal exercise
- Male
- Not taking any anticoagulant or anti-inflammatory medication
- Between the ages 18-50
- White European or South Asian
Who cannot join
- Those that are taking any anticoagulant or anti-inflammatory medication
- Those with a known medical condition such as diabetes, cardiovascular disease.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Applied & Human Sciences Human Performance Lab
Kingston upon Thames, Surrey, KT1 2EE
About this study
Official title: Exercise Effects on Appetite-regulating Hormones and Cardiovascular Risk Factors in South Asian and White European Men
The aim of this study is to examine the effect of a single bout of moderate exercise, standardized breakfast and buffet meal on appetite-related hormones, type two diabetes and cardiovascular risk factors with a comparison between healthy South Asian and white European men. It is of interest to see if any factor differences occur in appetite-regulating hormones and cardiovascular disease risk factors whilst exercising. If so strategies may be used to alter regulation in diet and exercise to reduce risk cardiovascular disease as this is the number one cause of death globally.
Read the detailed description
Cardiovascular diseases are recognised as the number one cause of death globally. Furthermore, diabetes is a major risk factor for cardiovascular disorders with abundant evidence showing that patients with type 2 diabetes (T2D) are at higher risk of cardiovascular disease (CVD) than those with a normal glycaemia.
In contrast to the declining numbers in the Western world, the prevalence of CVD and T2D is growing in low - and middle - income countries accompanied by a rapid increase of mortality and morbidity. Of interest, a rise in CVD prevalence has been particularly observed in people of South Asian origin including India, Bangladesh, Pakistan, Sri Lanka or Nepal with a projection showing that in this population deaths attributed to CVD will rise globally to nearly 36 % in 2030 compared to 29 % in 2005. South Asians collectively form 20% of the global population while in the UK they are the largest ethnic minority group representing over 5% of the total UK population .
Although the majority of research has been conducted mainly on White individuals, recent studies have revealed that traditional CVD risk factors such as hypertension, dyslipidaemia, insulin resistance and diabetes are higher in South Asians than other ethnicities. The factors underlying the high CVD risk in this population remain largely unexplained even though genetic predisposition and physical inactivity could play a key role. In contrast to European counterparts, sedentary lifestyles or physical inactivity have been identified as an important coronary heart disease (CHD) risk factor in South Asians. A systematic review from the United Kingdom (U.K.) showed that South Asians are participating in up to 50-75% less physical activity compared to their European counterparts.
In addition to the traditional risk factors there are emerging biomarkers which could represent meaningful predictors of metabolic disorders and related complications. Specifically, appetite hormones secreted mainly by the gastrointestinal tract, such as Acylated Ghrelin or Peptide YY (PYY) have shown potential effects on glucose homeostasis and cardiovascular system. Current experimental studies suggest beneficial cardiovascular, anti-inflammatory and anti-apoptotic effects of ghrelin in the cardiovascular system.
Although evidence suggests that ghrelin may be a potential metabolic risk factor and is important in appetite regulation, no studies to the researcher's knowledge have examined changes of this peptide in South Asians despite the fact that CVD and T2D burden in the South Asian population is growing. Likewise, although studies have investigated the effects of exercise on ghrelin and other appetite hormones, no study has taken in consideration the effects of exercise on appetite gut hormones in South Asian populations.
Therefore, this research project aims to examine specific appetite hormones in response to a single bout of exercise, standardised meal and ad libitum buffet meal, with a comparison between South Asians and White Europeans identifying potential relationships with genetic and other metabolic risk factors.
- Conditions
- Risk Factor, Cardiovascular, Physical Activity, Pre-diabetes
- Being tested
- Exercise
- Medical subject headings
- Motor Activity, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Participants will be required to complete two, 8-hours trials (exercise \& control) in a randomised order, preceded by 2 hours of preliminary testing (baseline) with no more than 14 days between conditions.
| Study group | Role | What they receive |
|---|---|---|
| European males | This study will involve a cohort of 15 White European men, between the ages of 18-50 years. Participants will be non-smokers, not dieting, and physically well to participate.
Participants will be required to exercise on one occasion. Receives: Behavioral: Exercise | |
| South Asian males | This study will involve a cohort of 15 South Asian (India, Pakistan, Sri Lanka, Nepal, Bangladesh, Maldives and Bhutan), men, between the ages of 18-50 years. Participants will be non-smokers, not dieting, and physically well to participate.
Participants will be required to exercise on one occasion. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Acylated ghrelin concentration
Plasma acylated ghrelin will be examined before and after the standardised breakfast, libitum buffet meal and exercise and before leaving the laboratory (please refer to study design for details). Commercially available enzyme-linked immunosorbent assays (Bertin Bioreagent, Montigny le Bretonneux, France) will be used to measure plasma acylated ghrelin concentration. The sample will be collected from whole blood using venepuncture.
Measured: 2 days
Secondary outcomes (7)
Plasma TAG concentration
Plasma Insulin will be also examined before and after the standardised breakfast, libitum buffet meal and exercise and before leaving the laboratory (please refer to study design for details). Commercially available enzyme-linked immunosorbent assays (Mercodia, Uppsala, Sweden) will be used to measure plasma Insulin concentration. The sample will be collected from whole blood using venepuncture.
Measured: 2 days
Plasma triacylglycerol (TAG) concentration
Plasma TAG concentration will be determined before and after the standardised breakfast, libitum buffet meal and exercise and before leaving the laboratory (please refer to study design for details) by enzymatic, colorimetric methods using a bench top analyser (Pentra 400; HORIBA ABX Diagnostics, Montpellier, France). The sample will be collected from whole blood using venepuncture.
Measured: 2 days
Plasma high-density lipoprotein (HDL) cholesterol concentration
Plasma HDL concentration will be determined before and after the standardised breakfast, libitum buffet meal and exercise and before leaving the laboratory (please refer to study design for details) by enzymatic, colorimetric methods using a bench top analyser (Pentra 400; HORIBA ABX Diagnostics, Montpellier, France). The sample will be collected from whole blood using venepuncture.
Measured: 2 days
Cardiorespiratory fitness
Cardiorespiratory fitness will be determined during the preliminary test (please refer to study design for details) using an incremental exercise test to volitional exhaustion on an electromagnetically braked cycle ergometer (Lode Excalibur Sport, Groningen, Netherlands). Participants will cycle at a self-selected pedal rate between 70 to 90 revolutions per minute for 3 min at 80 watts (warm up), followed by increments of 30 watts every 3 minutes until volitional fatigue. The sample will be collected from whole blood using venepuncture.
Measured: 2 days
Plasma Glucose concentration for impaired glucose tolerance (IGT)
Plasma glucose concentration will be determined before and after the standardised breakfast, libitum buffet meal and exercise and before leaving the laboratory (please refer to study design for details) by enzymatic, colorimetric methods using a bench top analyser (Pentra 400; HORIBA ABX Diagnostics, Montpellier, France). The sample will be collected from whole blood using venepuncture.
Measured: 2 days
Plasma Peptide YY concentration
Plasma PYY will be also examined before and after the standardised breakfast, libitum buffet meal and exercise and before leaving the laboratory (please refer to study design for details). Commercially available enzyme-linked immunosorbent assays (Millipore, Billerica, USA) will be used to measure plasma PYY concentration. The sample will be collected from whole blood using venepuncture.
Measured: 2 days
Plasma Leptin concentration
Plasma leptin will be also examined before and after the standardised breakfast, libitum buffet meal and exercise and before leaving the laboratory (please refer to study design for details). Commercially available enzyme-linked immunosorbent assays (Millipore, Billerica, USA) will be used to measure plasma leptin concentration. The sample will be collected from whole blood using venepuncture.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start24 May 2017
- Primary completion23 Dec 2018
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Risk Factor, CardiovascularStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kingston University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hannah Moir, Kingston University
- Investigators
- Juliet Juliet, Study chair, Kingston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03698786
- Sponsor's protocol ID
- KingstonUSport2
- Status last verified
- Mar 2019
- First submitted
- 27 Sep 2018
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gijsberts CM, den Ruijter HM, Asselbergs FW, Chan MY, de Kleijn DP, Hoefer IE. Biomarkers of Coronary Artery Disease Differ Between Asians and Caucasians in the General Population. Glob Heart. 2015 Dec;10(4):301-311.e11. doi: 10.1016/j.gheart.2014.11.004. Epub 2015 Mar 7.
PubMed 26014657Gujral UP, Pradeepa R, Weber MB, Narayan KM, Mohan V. Type 2 diabetes in South Asians: similarities and differences with white Caucasian and other populations. Ann N Y Acad Sci. 2013 Apr;1281(1):51-63. doi: 10.1111/j.1749-6632.2012.06838.x. Epub 2013 Jan 14.
PubMed 23317344Huang Y, Cai X, Mai W, Li M, Hu Y. Association between prediabetes and risk of cardiovascular disease and all cause mortality: systematic review and meta-analysis. BMJ. 2016 Nov 23;355:i5953. doi: 10.1136/bmj.i5953.
PubMed 27881363Wulan SN, Westerterp KR, Plasqui G. Metabolic profile before and after short-term overfeeding with a high-fat diet: a comparison between South Asian and White men. Br J Nutr. 2014 May 28;111(10):1853-61. doi: 10.1017/S0007114514000014. Epub 2014 Feb 10.
PubMed 24506887Bailey DP, Smith LR, Chrismas BC, Taylor L, Stensel DJ, Deighton K, Douglas JA, Kerr CJ. Appetite and gut hormone responses to moderate-intensity continuous exercise versus high-intensity interval exercise, in normoxic and hypoxic conditions. Appetite. 2015 Jun;89:237-45. doi: 10.1016/j.appet.2015.02.019. Epub 2015 Feb 17.
PubMed 25700630Deighton K, Barry R, Connon CE, Stensel DJ. Appetite, gut hormone and energy intake responses to low volume sprint interval and traditional endurance exercise. Eur J Appl Physiol. 2013 May;113(5):1147-56. doi: 10.1007/s00421-012-2535-1. Epub 2012 Oct 31.
PubMed 23111564Gholap N, Davies M, Patel K, Sattar N, Khunti K. Type 2 diabetes and cardiovascular disease in South Asians. Prim Care Diabetes. 2011 Apr;5(1):45-56. doi: 10.1016/j.pcd.2010.08.002. Epub 2010 Sep 25.
PubMed 20869934King JA, Garnham JO, Jackson AP, Kelly BM, Xenophontos S, Nimmo MA. Appetite-regulatory hormone responses on the day following a prolonged bout of moderate-intensity exercise. Physiol Behav. 2015 Mar 15;141:23-31. doi: 10.1016/j.physbeh.2014.12.050. Epub 2015 Jan 3.
PubMed 25562575
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Effects on Appetite-regulating Hormones and Cardiovascular Risk Factors in South Asian and White European Men
- ClinicalTrials.gov ID
- NCT03698786
- Acronym / sponsor ID
- KingstonUSport2
- Conditions
- Risk Factor, Cardiovascular, Physical Activity, Pre-diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Kingston UniversityUniversity, hospital or other
- Study start
- 24 May 2017 (actual)
- Primary completion
- 23 Dec 2018 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 9 Oct 2018 (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.
The aim of this study is to examine the effect of a single bout of moderate exercise, standardized breakfast and buffet meal on appetite-related hormones, type two diabetes and cardiovascular risk factors with a comparison between healthy South Asian and white European men. It is of interest to see if any factor differences occur in appetite-regulating hormones and cardiovascular disease risk factors whilst exercising. If so strategies may be used to alter regulation in diet and exercise to reduce risk cardiovascular disease as this is the number one cause of death globally.
Detailed description
Cardiovascular diseases are recognised as the number one cause of death globally. Furthermore, diabetes is a major risk factor for cardiovascular disorders with abundant evidence showing that patients with type 2 diabetes (T2D) are at higher risk of cardiovascular disease (CVD) than those with a normal glycaemia.
In contrast to the declining numbers in the Western world, the prevalence of CVD and T2D is growing in low - and middle - income countries accompanied by a rapid increase of mortality and morbidity. Of interest, a rise in CVD prevalence has been particularly observed in people of South Asian origin including India, Bangladesh, Pakistan, Sri Lanka or Nepal with a projection showing that in this population deaths attributed to CVD will rise globally to nearly 36 % in 2030 compared to 29 % in 2005. South Asians collectively form 20% of the global population while in the UK they are the largest ethnic minority group representing over 5% of the total UK population .
Although the majority of research has been conducted mainly on White individuals, recent studies have revealed that traditional CVD risk factors such as hypertension, dyslipidaemia, insulin resistance and diabetes are higher in South Asians than other ethnicities. The factors underlying the high CVD risk in this population remain largely unexplained even though genetic predisposition and physical inactivity could play a key role. In contrast to European counterparts, sedentary lifestyles or physical inactivity have been identified as an important coronary heart disease (CHD) risk factor in South Asians. A systematic review from the United Kingdom (U.K.) showed that South Asians are participating in up to 50-75% less physical activity compared to their European counterparts.
In addition to the traditional risk factors there are emerging biomarkers which could represent meaningful predictors of metabolic disorders and related complications. Specifically, appetite hormones secreted mainly by the gastrointestinal tract, such as Acylated Ghrelin or Peptide YY (PYY) have shown potential effects on glucose homeostasis and cardiovascular system. Current experimental studies suggest beneficial cardiovascular, anti-inflammatory and anti-apoptotic effects of ghrelin in the cardiovascular system.
Although evidence suggests that ghrelin may be a potential metabolic risk factor and is important in appetite regulation, no studies to the researcher's knowledge have examined changes of this peptide in South Asians despite the fact that CVD and T2D burden in the South Asian population is growing. Likewise, although studies have investigated the effects of exercise on ghrelin and other appetite hormones, no study has taken in consideration the effects of exercise on appetite gut hormones in South Asian populations.
Therefore, this research project aims to examine specific appetite hormones in response to a single bout of exercise, standardised meal and ad libitum buffet meal, with a comparison between South Asians and White Europeans identifying potential relationships with genetic and other metabolic risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| European males | – | Behavioral: ExerciseThis study will involve a cohort of 15 White European men, between the ages of 18-50 years. Participants will be non-smokers, not dieting, and physically well to participate. Participants will be required to exercise on one occasion. |
| South Asian males | – | Behavioral: ExerciseThis study will involve a cohort of 15 South Asian (India, Pakistan, Sri Lanka, Nepal, Bangladesh, Maldives and Bhutan), men, between the ages of 18-50 years. Participants will be non-smokers, not dieting, and physically well to participate. Participants will be required to exercise on one occasion. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study will involve a cohort of 15 White European and 15 South Asian (India, Pakistan, Sri Lanka, Nepal, Bangladesh, Maldives and Bhutan), men, between the ages of 18-50 years with no known underlying disease.
Key inclusion criteria (7 listed)
- Non-smoker
- Non-dieting
- Physically well to participant in maximal exercise
- Male
- Not taking any anticoagulant or anti-inflammatory medication
Key exclusion criteria (2 listed)
- Those that are taking any anticoagulant or anti-inflammatory medication
- Those with a known medical condition such as diabetes, cardiovascular disease.
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 |
|---|---|---|
| ExerciseParticipants will be required to complete two, 8-hours trials (exercise \& control) in a randomised order, preceded by 2 hours of preliminary testing (baseline) with no more than 14 days between conditions. | Behavioural | European males, South Asian males |
Primary outcome
Plasma Acylated ghrelin concentration
Time frame: 2 days
Plasma acylated ghrelin will be examined before and after the standardised breakfast, libitum buffet meal and exercise and before leaving the laboratory (please refer to study design for details). Commercially available enzyme-linked immunosorbent assays (Bertin Bioreagent, Montigny le Bretonneux, France) will be used to measure plasma acylated ghrelin concentration. The sample will be collected from whole blood using venepuncture.
7 secondary outcomes
Plasma TAG concentration
Time frame: 2 days
Plasma triacylglycerol (TAG) concentration
Time frame: 2 days
Plasma high-density lipoprotein (HDL) cholesterol concentration
Time frame: 2 days
Cardiorespiratory fitness
Time frame: 2 days
Plasma Glucose concentration for impaired glucose tolerance (IGT)
Time frame: 2 days
Plasma Peptide YY concentration
Time frame: 2 days
Plasma Leptin concentration
Time frame: 2 days
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 13 Mar 2019.
- Background: PubMed 26014657Gijsberts CM, den Ruijter HM, Asselbergs FW, Chan MY, de Kleijn DP, Hoefer IE. Biomarkers of Coronary Artery Disease Differ Between Asians and Caucasians in the General Population. Glob Heart. 2015 Dec;10(4):301-311.e11. doi: 10.1016/j.gheart.2014.11.004. Epub 2015 Mar 7.
- Background: PubMed 23317344Gujral UP, Pradeepa R, Weber MB, Narayan KM, Mohan V. Type 2 diabetes in South Asians: similarities and differences with white Caucasian and other populations. Ann N Y Acad Sci. 2013 Apr;1281(1):51-63. doi: 10.1111/j.1749-6632.2012.06838.x. Epub 2013 Jan 14.
- Background: PubMed 27881363Huang Y, Cai X, Mai W, Li M, Hu Y. Association between prediabetes and risk of cardiovascular disease and all cause mortality: systematic review and meta-analysis. BMJ. 2016 Nov 23;355:i5953. doi: 10.1136/bmj.i5953.
- Background: PubMed 24506887Wulan SN, Westerterp KR, Plasqui G. Metabolic profile before and after short-term overfeeding with a high-fat diet: a comparison between South Asian and White men. Br J Nutr. 2014 May 28;111(10):1853-61. doi: 10.1017/S0007114514000014. Epub 2014 Feb 10.
- Background: PubMed 25700630Bailey DP, Smith LR, Chrismas BC, Taylor L, Stensel DJ, Deighton K, Douglas JA, Kerr CJ. Appetite and gut hormone responses to moderate-intensity continuous exercise versus high-intensity interval exercise, in normoxic and hypoxic conditions. Appetite. 2015 Jun;89:237-45. doi: 10.1016/j.appet.2015.02.019. Epub 2015 Feb 17.
- Background: PubMed 23111564Deighton K, Barry R, Connon CE, Stensel DJ. Appetite, gut hormone and energy intake responses to low volume sprint interval and traditional endurance exercise. Eur J Appl Physiol. 2013 May;113(5):1147-56. doi: 10.1007/s00421-012-2535-1. Epub 2012 Oct 31.
- Background: PubMed 20869934Gholap N, Davies M, Patel K, Sattar N, Khunti K. Type 2 diabetes and cardiovascular disease in South Asians. Prim Care Diabetes. 2011 Apr;5(1):45-56. doi: 10.1016/j.pcd.2010.08.002. Epub 2010 Sep 25.
- Background: PubMed 25562575King JA, Garnham JO, Jackson AP, Kelly BM, Xenophontos S, Nimmo MA. Appetite-regulatory hormone responses on the day following a prolonged bout of moderate-intensity exercise. Physiol Behav. 2015 Mar 15;141:23-31. doi: 10.1016/j.physbeh.2014.12.050. Epub 2015 Jan 3.
- Individual participant dataSharing planned: No
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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.
Juliet Juliet study chair
Kingston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Risk Factor, Cardiovascular and Physical Activity, run by Kingston University 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 7 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 13 Mar 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?
Plasma Acylated ghrelin concentration (time frame: 2 days). 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 NCT03698786, which also lists 8 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 13 Mar 2019.