Complex Effects of Dietary Manipulation on Metabolic Function, Inflammation and Health
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.
Conditions:
🦠 Obesity 🦠 Insulin Resistance
🗓️ Study Start (Actual) February 2016
🗓️ Primary Completion (Estimated) July 2025
✅ Study Completion (Estimated) December 2025
👥 Enrollment (Estimated) 180
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Saint Louis, Missouri, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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.

    Exclusion Criteria:

    • * 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
    • * Structured exercise ≥250 min per week (e.g., brisk walking)
    • * Unstable weight (\>4% change during the last 2 months before entering the study)
    • * Significant organ system dysfunction (e.g., diabetes requiring medications, severe pulmonary, kidney or cardiovascular disease)
    • * Polycystic ovary syndrome
    • * Cancer or cancer that has been in remission for \<5 years
    • * 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)
    • * 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 of antibiotics in last 60 days
    • * Smoke cigarettes \> 10 cigarettes/week
    • * Use marijuana \>2 x/week, or use of illegal drugs
    • * 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
    • * 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
    • * 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
Ages Eligible for Study: 18 Years to 55 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 24 February 2016
  • First Submitted that Met QC Criteria 7 March 2016
  • First Posted 11 March 2016

Study Record Updates

  • Last Update Submitted that Met QC Criteria 22 May 2024
  • Last Update Posted 24 May 2024
  • Last Verified May 2024