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OpenTrials
Completed

NCT Number: NCT03531879

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

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Key information

Age range

40 year–54 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nestle Research Center

Lausanne, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. To compare the kinetics of postprandial biomarkers between two groups of healthy subjects with and without subclinical atherosclerosis

    Time frame: Within 28 days from enrollment

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Collaborators

  • Institute for Human Development and Potential (IHDP), Singapore
  • National Heart Centre Singapore

Registry information

Official study title

ARROW: identificAtion of postpRandial biomaRkers tOWards Cardiovascular Prevention

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 22, 2018
Registry last updated
Jul 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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