ARROW:identificAtion of postpRandial biomaRkers tOWards Cardiovascular Prevention

Cardiovascular Diseases Clinical Trial

Official title:

ARROW: identificAtion of postpRandial biomaRkers tOWards Cardiovascular Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03531879
• Other study ID #: 17.15.NRC
• Status: Completed
• Start date: May 23, 2018
• Est. completion date: June 14, 2019

Study information

• Verified date: July 2020
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: June 14, 2019
• Est. primary completion date: June 14, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 54 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cardiovascular Diseases

Locations

Country	Name	City	State
Switzerland	Nestle Research Center	Lausanne

Sponsors (3)

Lead Sponsor	Collaborator
Nestlé	National Heart Centre Singapore, Singapore Institute for Clinical Sciences

Country where clinical trial is conducted

Switzerland, 

Outcome

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