ARROW:identificAtion of postpRandial biomaRkers tOWards Cardiovascular Prevention

ARROW: identificAtion of postpRandial biomaRkers tOWards Cardiovascular Prevention

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03531879

Enrollment

116

Registered

2018-05-22

Start date

2018-05-23

Completion date

2019-06-14

Last updated

2020-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

Brief 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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

40 Years to 54 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

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

Countries

Switzerland

Outcome results