Sign in

NCT02706262Active, not recruiting

Complex Effects of Dietary Manipulation on Metabolic Function, Inflammation and Health

Source: ClinicalTrials.gov · Last updated 27 Jan 2026

Brief summary (registry, in English)

The purpose of this research study is to 1) understand how some, but not all people with obesity develop obesity related conditions such as type 2 diabetes and cardiovascular disease, and 2) compare the effects of 3 popular weight loss diets (Mediterranean, low-carbohydrate, or a very-low-fat plant-based diet) in people with obesity.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
180 (estimated)
First submitted
24 Feb 2016
Start date
1 Feb 2016
Primary completion date
30 Apr 2025
Lead sponsor
Washington University School of Medicine
Diseases
Obesity
NCT number
NCT02706262

What you commit to

  • Study type: Interventional
  • Planned participants: 180
  • From 1 Feb 2016 to the primary completion date, 30 Apr 2025
  • 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
  • Use marijuana \>2 x/week, or use of illegal drugs

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)
  • Use of antibiotics in last 60 days
  • Smoke cigarettes \> 10 cigarettes/week
  • Men who consume \>21 units (e.g. glass of wine or bottle of beer) of alcohol per week and women who consume \>14 units of alcohol per week
  • Pregnant or lactating women
  • Persons who are not able to grant voluntary informed consent
  • Persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers not an appropriate candidate for this study, including non-compliance with screening appointments or study visits

Who the study is looking for

  • Metabolically normal lean subjects must have a BMI ≥18.5 and ≤24.9 kg/m2; Obese subjects must have a BMI ≥30.0 and ≤50.0 kg/m2
  • Metabolically normal lean and obese subjects must have intrahepatic triglyceride (IHTG) content ≤5%; plasma triglyceride (TG) concentration \<150 mg/dl; fasting plasma glucose concentration \<100 mg/dl, 2-hr oral glucose tolerance plasma glucose concentration \<140 mg/dl, and hemoglobin A1C ≤5.6%
  • Metabolically abnormal obese subjects must have intrahepatic triglyceride (IHTG) content ≥5.6%; HbA1C ≥5.7%, or fasting plasma glucose concentration ≥100 mg/dl, or 2-hr oral glucose tolerance test (OGTT) plasma glucose concentration ≥140 mg/dl.

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.