ARROW:identificAtion of postpRandial biomaRkers tOWards Cardiovascular Prevention

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

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases

• Study Type: Observational
• Enrollment (Actual): 116

Contacts and Locations

Study Locations

• Switzerland
  • Lausanne, Switzerland
    • Nestlé Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 54 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
subject with plaques and without plaques; Subject with plaques and without plaques

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Nestlé
• Collaborators: Singapore Institute for Clinical Sciences; National Heart Centre Singapore

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2018
• Primary Completion (Actual): June 14, 2019
• Study Completion (Actual): June 14, 2019

Study Registration Dates

• First Submitted: May 9, 2018
• First Submitted That Met QC Criteria: May 9, 2018
• First Posted (Actual): May 22, 2018

Study Record Updates

• Last Update Posted (Actual): July 23, 2020
• Last Update Submitted That Met QC Criteria: July 22, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 17.15.NRC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No