ARROW:identificAtion of postpRandial biomaRkers tOWards C... | NCT03531879

Studies
ARROW:identificAtion of postpRandial biomaRkers tOWards Cardiovascular Prevention

NCT03531879

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Jul 23, 2020Actual

Enrollment

116Actual

Phase

Not provided

Conditions

Cardiovascular Diseases

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 23, 2018Actual

Primary Completion Date

Jun 14, 2019Actual

Completion Date

Jun 14, 2019Actual

First Submitted Date

May 9, 2018

First Submission Date that Met QC Criteria

May 9, 2018

First Posted Date

May 22, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2020

Last Update Posted Date

Jul 23, 2020Actual

Name	Class
Institute for Human Development and Potential (IHDP), Singapore	OTHER
National Heart Centre Singapore	OTHER

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

116Actual

Label	Type	Description	Intervention Names
subject with plaques and without plaques		Subject with plaques and without plaques

Measure	Description	Time Frame
To compare the kinetics of postprandial biomarkers between two groups of healthy subjects with and without subclinical atherosclerosis		Within 28 days from enrollment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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).
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).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

54 Years

Standard Ages

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.

Sampling Method

Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36207366	Derived	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.
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