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NCT04131166Active, not recruiting

Precision Nutrition and Metabolic Function

Source: ClinicalTrials.gov · Last updated 6 Jul 2026

Brief summary (registry, in English)

The purposes of this study are: 1) to determine the mechanisms responsible for the development of cardiometabolic complications in some, but not all people with obesity; 2) determine the best dietary approach for cardiometabolic health; and 3) understand why some people have a stable metabolic phenotype over time whereas cardiometabolic health improves or worsens in others.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
300 (estimated)
First submitted
15 Oct 2019
Start date
8 Oct 2019
Primary completion date
1 Oct 2029
Lead sponsor
Washington University School of Medicine
Diseases
Obesity
NCT number
NCT04131166

What you commit to

  • Study type: Interventional
  • Planned participants: 300
  • From 8 Oct 2019 to the primary completion date, 1 Oct 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • medical, surgical, or biological menopause;
  • previous bariatric surgery where the gastrointestinal tract is reconstructed such as Roux-en-Y, sleeve gastrectomy and biliopancreatic diversion surgeries;
  • laparoscopic adjustable gastric band (lab band) surgery within the last 3 years;
  • unstable weight (\>4% change during the last 2 months before entering the study);
  • use of medications that are known to affect the study outcome measures (e.g., steroids, non-statin lipid-lowering medications) or increase the risk of study procedures (e.g., anticoagulants) and that cannot be temporarily discontinued for this study;

Other illness

  • significant organ system dysfunction (e.g., diabetes requiring medications, severe pulmonary, kidney or cardiovascular disease);
  • polycystic ovary syndrome;
  • major psychiatric illness;
  • conditions that render subject unable to complete all testing procedures (e.g., severe ambulatory impairments, limb amputations, or metal implants that interfere with imaging procedures; coagulation disorders);
  • vegans, vegetarians, those with lactose intolerance and/or severe aversions/sensitivities to eggs, fish, nuts, wheat and soy, and/or any individuals with food allergies that induce an anaphylactic response;

Age

  • cancer or cancer that has been in remission for \<5 years;

Other

  • structured exercise ≥250 min per week (e.g., brisk walking);
  • severe anemia;
  • regular use of tobacco products;
  • excessive consumption of alcohol (≥3 drinks/day for men and ≥2 drinks/day for women);
  • use of antibiotics in last 60 days;
  • pregnant or lactating women;
  • persons who are not able to grant voluntary informed consent

Who the study is looking for

  • Metabolically healthy lean subjects must have a body mass index (BMI) 18.5-24.9 kg/m², intrahepatic triglyceride (IHTG) content ≤5%, serum triglyceride (TG) concentration \<150 mg/dl, fasting plasma glucose concentration \<100 mg/dl, 2-hr oral glucose tolerance test (OGTT) plasma glucose concentration ≤140 mg/dl, and hemoglobin A1C (HbA1C) ≤5.6%.
  • Metabolically healthy obese subjects must have a BMI 30-49.9 kg/m²; IHTG content ≤5%, serum TG concentration \<150 mg/dl, fasting plasma glucose concentration \<100 mg/dl, 2-hr OGTT plasma glucose concentration ≤140 mg/dl, and HbA1C ≤5.6%.
  • Metabolically unhealthy obese subjects must have a BMI 30-49.9 kg/m²; IHTG content ≥5.6% and fasting plasma glucose concentration ≥100 mg/dl or 2-hr OGTT plasma glucose concentration ≥140 mg/dl or HbA1C ≥5.7%.

Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Washington University School of Medicine
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.