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Diet breaks may wreck metabolism and gut bugs, study warns

NCT ID NCT06782009

Knowledge-focused Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 what happens to the body when people with obesity stop following restrictive diets like calorie cutting or intermittent fasting. Researchers measured changes in mitochondria (the cell's energy factories) and gut bacteria in 84 adults over 24 weeks. The goal is to understand why weight regain often occurs and how it affects overall health.

What this could mean

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

Active substance
calorie restriction and intermittent fasting
What this could lead to
If successful, this could help explain why weight regain happens after dieting and point to ways to prevent it.
What could go wrong
This is a small, completed observational study, not a treatment trial. Results may not apply to everyone and do not test a new therapy.

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

84 people

The number who actually took part.

Started

Apr 2023

Finished

Dec 2025

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 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Male and female. * Adults \>18 years of age. * BMI ≥ 30 kg/m2 Exclusion Criteria: * Patients with any type of diabetes. * Patients with high blood pressure. * Patients with acquired diseases secondarily producing obesity and diabetes. * Patients who have suffered a cardiovascular event. * Patients who at the screening visit presented glucose values greater than 126 mg/dL, triglycerides greater than 350 mg/dL, cholesterol greater than 300mg/dL and/or creatinine greater than 1.2 mg/dL in men and greater than 1 mg/dL in women. * Patients with gastrointestinal diseases. * Weight loss \> 3 kg in the last 3 months. * Catabolic diseases such as cancer and acquired immunodeficiency syndrome. * Pregnancy status. * Positive smoking. * History of major surgery requiring general or regional anesthesia, respiratory support, and involving a recovery time longer than 2 weeks, such as surgeries of the abdomen (bowel resection), chest, head, and neck. * Diagnosis of Anxiety and Depression as Determined by the HADS Scale * Drug treatment: * Antihypertensive drugs or treatment * Treatment with hypoglycemic agents or insulin and antidiabetic drugs. * Treatment with statins, fibrates or other drugs to control dyslipidemia. * Use of antibiotics in the three months prior to the study. * Use of steroid drugs, chemotherapy, immunosuppressants, or radiation therapy. * Anorexigenic or that accelerate weight loss such as sibutramine or orlistat. * Supplements with any of the functional foods used in the study. * Probiotic, prebiotic or symbiotic supplements.

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Conditions

The condition(s) this trial relates to.

Intermittent Fasting Obesity obesity disorder

As listed by the trial registrant

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

Obesity

Contacts and locations

Locations

  • Departamento de Fisiología de la Nutrición. Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

    Mexico City, 14080, Mexico

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Mexico City, Tlalpan, 14080, Mexico

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