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Could your diet reshape your gut? new study says yes

NCT ID NCT05411120

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how switching from a typical Western diet (low fiber, high fat) to a Mediterranean-like diet (lots of veggies, fruits, whole grains) affects the trillions of tiny organisms living in your gut. 160 healthy adults aged 18 to 60 either followed the new diet for 4 weeks or up to 12 months. Researchers tracked changes in gut bacteria, diet quality, and weight to understand how food shapes our inner ecosystem.

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

160 people

The number who actually took part.

Started

Aug 2022

Finished

Feb 2026

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Ages

18 to 60 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: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Ability of subject to understand and the willingness to sign a written informed consent document * Age 18-60, at the time of consent * Willingness to adhere to the dietary regimen and report any major stressors that occur during the study (i.e. changing jobs, moving, death of a close relative/friend, etc.) * Willingness to provide blood and stool specimens as specified * BMI \>=18 and \<= 35 kg/m\^2 * Access to necessary resources for participating in a technology-based intervention: computer, smartphone, internet access, etc. * Has the ability/transportation methods to attend on-site visits * For 50 of the 60 participants in short-term cohort and for 40 of the 50 participants in the long-term cohort: Currently following a Western diet with PREDIMED-17 MedDiet score \<= 7 for \>= 1 months and a CLEAN-MED NOVA score of \>= 35% kcal in NOVA 4 category with \>= 14 items/week in NOVA 4 * For 10 of the 60 participants in short-term cohort and for 10 of the 50 participants in the long-term cohort: Currently following a Western diet with PREDIMED-17 MedDiet score \<= 10 for \>= 1 months and a CLEAN-MED NOVA score of \>= 20% kcal in NOVA 4 category with \>= 7 items/week in NOVA 4 * CLEAN-MED Logging Score of \>= 43 after initial trial week to continue in the study for the randomization step * For long-term cohort only: Have resources and capability to consume freshly-cooked (i.e. not pre-packaged or frozen) meals EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study, at the discretion of the PI: * Current use of medications or dietary supplements for weight or appetite control, whether prescribed or not, including laxatives (within the last 4 weeks) * Currently eating a vegan, vegetarian, keto or other restrictive diet plan, or food allergies that would affect eating the study diet, at the discretion of the PI * Active cardiovascular disease (in past year with myocardial infarction, coronary stent or bypass surgery) * Diabetes (type 1 and 2) or history of gestational diabetes or on hypoglycemic medications or any other indication * Kidney disease (eGFR less than 50 mL/min per 1.73 m\^2) * Liver disease (liver transaminase higher than 3 times the normal range for the laboratory) * Symptomatic gallstones * History of active cancer in the past 3 years except for squamous or basal cell carcinomas of the skin that have been medically managed by local excision * Has a diagnosed autoimmune condition (i.e. HIV, lupus, etc.) or other immunosuppressive or immunodeficient state, at the discretion of the PI * Musculoskeletal disorders precluding regular physical activity * Consumption of the following drugs: proton pump inhibitors, antidiabetic drugs, cholesterol lowering drugs, SGLT-2 inhibitors, GLP-1 receptor agonist, insulin, Amylin analog, Alpha-glucosidase inhibitor, Dopamine agonist, Bile acid sequestrant, corticosteroids, methotrexate or immunosuppressive cytotoxic agents * Some types of abdominal surgery, including bariatric surgery, or severe intestinal problems (by discretion of study physician), including: * Inflammatory bowel disease (IBD) including ulcerative colitis (mild-moderate-severe), Crohn s disease (mild-moderate-severe), or indeterminate colitis; * Irritable bowel syndrome (IBS) (moderate-severe); * Persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated); * Chronic constipation * Consumes more than 3 alcoholic beverages per day * Currently receiving or has received antibiotics, antifungals, antivirals, or antiparasitics in past 2 months * Is currently using or has used probiotic supplements within the last 2 months * Is currently on a weight-loss program or has experienced a weight change (gain or loss) of greater than 15 pounds in the past 3 months * Has a history of hospitalization for mental health condition and/or has had a change in depression or anxiety prescription medications within the past 10 weeks (by discretion of study physician) * Is pregnant or breastfeeding or planning pregnancy within the time of the study * Subjects who are not fluent in English * Use of smoking or chewing tobacco, e-cigarettes, cigars, or other nicotine-containing products, or cannabis * Regular use of prescription opiate pain medication * Weight \<100 lbs * Acute disease, defined as the presence of a moderate or severe illness with or without fever, at the time of enrollment * Inability to communicate effectively with study personnel * Lack of commitment with the intervention or non-compliance (at the discretion of the investigator) * Eating disorders

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As listed by the trial registrant

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

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

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