Cardiovascular DiseasesNCT03531879
ARROW:identificAtion of postpRandial biomaRkers tOWards Cardiovascular Prevention
An observational study of Cardiovascular Diseases, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
The purpose of this study is to better understand the association between the postprandial biomarker responses after a food challenge with the development of cardiovascular diseases in healthy subjects Read more about this study
- Who is it for?
- Ages 40 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 116 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 May 2018to 14 Jun 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 40 to 54 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This study will be performed in 100 Chinese subjects at low risk of developing cardiovascular diseases, as defined by the Framingham Heart Study Coronary Heart Disease 10-year risk score with or without subclinical atherosclerosis.
Who may be able to join
- Willing and able to sign written informed consent in English or Chinese prior to trial entry
- 40-54 years old
- Both male and female subjects
- Chinese ethnic group (having both grandparents Chinese)
- Low Framingham risk of CHD (<10%)
- Apparently healthy (i.e. no chronic or ongoing acute disease), based on investigator's clinical judgement
Who cannot join
- Food allergy to any of the constituents of the meal challenge (milk proteins, lactose, soy).
- Subjects not willing or not able to comply with scheduled visits and the requirements of the study protocol.
- Contraindication to MRI
- Pregnant or lactating women based on investigator's clinical judgement.
- Morbid obesity (BMI ≥ 40 kg/m2).
- Previous myocardial infarction (MI). This will include ST-elevation MI (STEMI) and non-ST-elevation MI (NSTEMI).
Show all 19Show fewer
- Known coronary artery disease - prior coronary revascularization.
- Known documented peripheral arterial disease.
- Previous stroke (defined as new focal neurological deficit persisting more than 24hours).
- Use of anti-hypertensive agents.
- Prior history of cancer (excludes pre-cancerous lesions).
- Life expectancy less than 1 year.
- Known definite diabetes mellitus or on treatment for diabetes mellitus.
- Known autoimmune disease or genetic disease.
- Known endocrine and metabolic diseases, even on treatment, including hyperlipidemia.
- Psychiatric illness.
- Asthma or chronic lung disease requiring long term medications or oxygen.
- Chronic infective disease, including tuberculosis, hepatitis B and C; and HIV.
- Currently participating or having participated in another clinical trial within 4 weeks prior to trial start (except for Biobank Study and SingHeart).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ARROW: identificAtion of postpRandial biomaRkers tOWards Cardiovascular Prevention
The purpose of this study is to better understand the association between the postprandial biomarker responses after a food challenge with the development of cardiovascular diseases in healthy subjects
- Conditions
- Cardiovascular Diseases
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| subject with plaques and without plaques | Subject with plaques and without plaques |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the kinetics of postprandial biomarkers between two groups of healthy subjects with and without subclinical atherosclerosis
Measured: Within 28 days from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start23 May 2018
- Primary completion14 Jun 2019
- Study completion14 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institute for Human Development and Potential (IHDP), Singapore, National Heart Centre Singapore
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531879
- Sponsor's protocol ID
- 17.15.NRC
- Status last verified
- Jul 2020
- First submitted
- 9 May 2018
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Loh X, Sun L, Allen JC, Goh HJ, Kong SC, Huang W, Ding C, Bosco N, Egli L, Actis-Goretta L, Magkos F, Arigoni F, Yeo KK, Leow MK. Gender differences in fasting and postprandial metabolic traits predictive of subclinical atherosclerosis in an asymptomatic Chinese population. Sci Rep. 2022 Oct 7;12(1):16890. doi: 10.1038/s41598-022-20714-6.
PubMed 36207366Valsesia A, Egli L, Bosco N, Magkos F, Kong SC, Sun L, Goh HJ, Weiting H, Arigoni F, Leow MK, Yeo KK, Actis-Goretta L. Clinical- and omics-based models of subclinical atherosclerosis in healthy Chinese adults: a cross-sectional exploratory study. Am J Clin Nutr. 2021 Nov 8;114(5):1752-1762. doi: 10.1093/ajcn/nqab269.
PubMed 34476468
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARROW: identificAtion of postpRandial biomaRkers tOWards Cardiovascular Prevention
- ClinicalTrials.gov ID
- NCT03531879
- Acronym / sponsor ID
- 17.15.NRC
- Conditions
- Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- Institute for Human Development and Potential (IHDP), Singapore, National Heart Centre Singapore
- Study start
- 23 May 2018 (actual)
- Primary completion
- 14 Jun 2019 (actual)
- Study completion
- 14 Jun 2019 (actual)
- First posted
- 22 May 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 purpose of this study is to better understand the association between the postprandial biomarker responses after a food challenge with the development of cardiovascular diseases in healthy subjects
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subject with plaques and without plaques | – | –Subject with plaques and without plaques |
Who may qualify
- Ages
- 40 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study will be performed in 100 Chinese subjects at low risk of developing cardiovascular diseases, as defined by the Framingham Heart Study Coronary Heart Disease 10-year risk score with or without subclinical atherosclerosis.
Key inclusion criteria (6 listed)
- Willing and able to sign written informed consent in English or Chinese prior to trial entry
- 40-54 years old
- Both male and female subjects
- Chinese ethnic group (having both grandparents Chinese)
- Low Framingham risk of CHD (<10%)
Key exclusion criteria (19 listed)
- Food allergy to any of the constituents of the meal challenge (milk proteins, lactose, soy).
- Subjects not willing or not able to comply with scheduled visits and the requirements of the study protocol.
- Contraindication to MRI
- Pregnant or lactating women based on investigator's clinical judgement.
- Morbid obesity (BMI ≥ 40 kg/m2).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To compare the kinetics of postprandial biomarkers between two groups of healthy subjects with and without subclinical atherosclerosis
Time frame: Within 28 days from enrollment
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 23 Jul 2020.
- Derived from this study: PubMed 36207366Loh X, Sun L, Allen JC, Goh HJ, Kong SC, Huang W, Ding C, Bosco N, Egli L, Actis-Goretta L, Magkos F, Arigoni F, Yeo KK, Leow MK. Gender differences in fasting and postprandial metabolic traits predictive of subclinical atherosclerosis in an asymptomatic Chinese population. Sci Rep. 2022 Oct 7;12(1):16890. doi: 10.1038/s41598-022-20714-6.
- Derived from this study: PubMed 34476468Valsesia A, Egli L, Bosco N, Magkos F, Kong SC, Sun L, Goh HJ, Weiting H, Arigoni F, Leow MK, Yeo KK, Actis-Goretta L. Clinical- and omics-based models of subclinical atherosclerosis in healthy Chinese adults: a cross-sectional exploratory study. Am J Clin Nutr. 2021 Nov 8;114(5):1752-1762. doi: 10.1093/ajcn/nqab269.
- Individual participant dataSharing planned: Undecided
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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.
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?
An observational study of Cardiovascular Diseases, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
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 6 inclusion and 19 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 23 Jul 2020. 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 Switzerland. 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?
To compare the kinetics of postprandial biomarkers between two groups of healthy subjects with and without subclinical atherosclerosis (time frame: Within 28 days from enrollment). 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 NCT03531879, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.