ARROW:identificAtion of postpRandial biomaRkers tOWards Cardiovascular Prevention

NCT ID: NCT03531879

Last Updated: 2020-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-23

Study Completion Date

2019-06-14

Brief Summary

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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

Detailed Description

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Conditions

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Cardiovascular Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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subject with plaques and without plaques

Subject with plaques and without plaques

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Willing and able to sign written informed consent in English or Chinese prior to trial entry
2. 40-54 years old
3. Both male and female subjects
4. Chinese ethnic group (having both grandparents Chinese)
5. Low Framingham risk of CHD (\<10%)
6. Apparently healthy (i.e. no chronic or ongoing acute disease), based on investigator's clinical judgement

Exclusion Criteria

1. Food allergy to any of the constituents of the meal challenge (milk proteins, lactose, soy).
2. Subjects not willing or not able to comply with scheduled visits and the requirements of the study protocol.
3. Contraindication to MRI
4. Pregnant or lactating women based on investigator's clinical judgement.
5. Morbid obesity (BMI ≥ 40 kg/m2).
6. Previous myocardial infarction (MI). This will include ST-elevation MI (STEMI) and non-ST-elevation MI (NSTEMI).
7. Known coronary artery disease - prior coronary revascularization.
8. Known documented peripheral arterial disease.
9. Previous stroke (defined as new focal neurological deficit persisting more than 24hours).
10. Use of anti-hypertensive agents.
11. Prior history of cancer (excludes pre-cancerous lesions).
12. Life expectancy less than 1 year.
13. Known definite diabetes mellitus or on treatment for diabetes mellitus.
14. Known autoimmune disease or genetic disease.
15. Known endocrine and metabolic diseases, even on treatment, including hyperlipidemia.
16. Psychiatric illness.
17. Asthma or chronic lung disease requiring long term medications or oxygen.
18. Chronic infective disease, including tuberculosis, hepatitis B and C; and HIV.
19. Currently participating or having participated in another clinical trial within 4 weeks prior to trial start (except for Biobank Study and SingHeart).
Minimum Eligible Age

40 Years

Maximum Eligible Age

54 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institute for Human Development and Potential (IHDP), Singapore

OTHER

Sponsor Role collaborator

National Heart Centre Singapore

OTHER

Sponsor Role collaborator

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nestle Research Center

Lausanne, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 36207366 (View on PubMed)

Valsesia 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.

Reference Type DERIVED
PMID: 34476468 (View on PubMed)

Other Identifiers

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17.15.NRC

Identifier Type: -

Identifier Source: org_study_id

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