NCT03531879

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 22, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

May 23, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2019

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

1.1 years

First QC Date

May 9, 2018

Last Update Submit

July 22, 2020

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

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

    Within 28 days from enrollment

Study Arms (1)

subject with plaques and without plaques

Subject with plaques and without plaques

Eligibility Criteria

Age40 Years - 54 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • Willing and able to sign written informed consent in English or Chinese prior to trial entry
  • 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

You may not qualify if:

  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nestle Research Center

Lausanne, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 36207366DERIVED

  • 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.

    PMID: 34476468DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and plasma

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2018

First Posted

May 22, 2018

Study Start

May 23, 2018

Primary Completion

June 14, 2019

Study Completion

June 14, 2019

Last Updated

July 23, 2020

Record last verified: 2020-07

Locations

CH(1)