ARROW:identificAtion of postpRandial biomaRkers tOWards Cardiovascular Prevention

Completed

• Conditions: Cardiovascular Diseases

• Registration Number: NCT03531879
• Lead Sponsor: Société des Produits Nestlé (SPN)

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-09
• Study First Submitted QC: 2018-05-09
• Study First Posted: 2018-05-22
• Study Start: 2018-05-23
• Primary Completion: 2019-06-14
• Study Completion: 2019-06-14
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-22
• Last Update Posted: 2020-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Nestle Research Center; 🇨🇭 Lausanne, Switzerland