Can a tailored diet unlock better metabolic health?

NCT ID NCT04131166

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This study investigates why some people with obesity develop heart and metabolic problems while others do not, and which diet—Mediterranean, low-carb, or low-fat—best supports metabolic health. Researchers will follow 300 participants, including lean and obese individuals, over several years, measuring insulin sensitivity and glucose levels. The goal is to understand how to personalize dietary recommendations for better long-term health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mediterranean diet, low-carbohydrate ketogenic diet, low-fat diet
What this could lead to
If successful, this could identify which diet works best for different individuals, paving the way for personalized nutrition plans to improve metabolic health.
What could go wrong
This is an observational and behavioral study, not a treatment trial. Results may not apply to everyone, and dietary adherence can vary widely.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2019

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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%. 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); * cancer or cancer that has been in remission for \<5 years; * 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); * severe anemia; * regular use of tobacco products; * excessive consumption of alcohol (≥3 drinks/day for men and ≥2 drinks/day for women); * 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; * 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

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Conditions

The condition(s) this trial relates to.

Insulin Resistance Obesity obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

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