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Recruiting

NCT Number: NCT05494138

Nutriomics and Artificial Intelligence Nutrition Obesity Cohort

The purpose of this study is to establish a prospective cohort. From registration to the 5th year, basic investigation, specific examinations for cardiovascular and metabolic disease, basic blood tests, collection of human material samples, and clinical event follow-up are conducted yearly. The obese group will be examined yearly, and telephone follow-up will be conducted if necessary. The control group will participate in the baseline survey once enrollment and clinical event follow-up by phone will be conducted annually thereafter. From the 6th year, only clinical event follow-up will be conducted.

Recruiting

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

Sungha Park

CONTACT

[email protected]

+82-2-2228-8455

About this study

The obese group will enroll 500 people within 1 year of study initiation and follow-up annually. The control group will enroll 30 patients a year for 5 years.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

for the obese group

  • Adults 19 years of age or older
  • Obese patients with chronic diseases such as cardiovascular disease, hypertension, diabetes, and metabolic syndrome (BMI ≥ 25 kg/m2, [BMI ≥ 30 kg/m2, including 10% or more])

Inclusion criteria

for the control group

  • Adults 19 years of age or older
  • Those with BMI 18.5~24.9 kg/m2

Exclusion criteria

for the obese group

  • Serious non-cardiovascular disease with life expectancy less than 6 months
  • Pregnant or suspected of being pregnant or are lactating
  • Patients within 3 months of organ transplantation
  • Patients currently being treated for acute transplant rejection
  • Patients treated for acute coronary syndrome (myocardial infarction, unstable angina) and discharged within 6 months
  • Patients with acute cerebral infarction within 6 months of being hospitalized and discharged
  • Type 1 Diabetes
  • Patients taking steroids, female hormones
  • Those who have difficulty using smartphones

Exclusion criteria

for the control group

  • Serious non-cardiovascular disease with life expectancy less than 6 months
  • Pregnant or suspected of being pregnant or are lactating
  • Persons who are continuously taking medications prescribed by a doctor due to chronic diseases excluding hypertension and dyslipidemia
  • Within 5 years of diagnosis of malignant tumor
  • Those who have difficulty using smartphones

Treatment and study plan

Primary outcomes

  1. Differences of nutriomics according to obesity phenotypes

    Time frame: At five years of study

    Cross-sectional analysis of nutriomics of normal control group and obese patients

Secondary outcomes

  1. Clinical events

    Time frame: three years, four years, five years, etc

    A composite of all-cause mortality, cardiovascular mortality, non-fatal myocardial infarction, non-fatal stroke, revascularization of coronary artery, and heart failure hospitalization

Study contacts

Contact information is provided by the study sponsor or research team.

Sungha Park

CONTACT

[email protected]

+82-2-2228-8455

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2041
First posted
Aug 9, 2022
Registry last updated
Aug 9, 2022

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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