Pre-Surgery diet could shrink liver and boost safety for obesity patients

NCT ID NCT04942093

Symptom relief Sponsor: University Hospital, Rouen Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study looks at whether a 4-week low-calorie, high-protein diet before bariatric surgery is safe and well-tolerated. Researchers want to see if it reduces liver fat and helps surgeons operate more easily. About 200 people with severe obesity will be split into two groups: one follows the diet, the other does not. The main focus is on side effects like low blood counts, vitamin deficiency, or muscle weakness.

What this could mean

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

Active substance: low-calorie, high-protein diet
What this could lead to: If successful, this diet could become a standard short-term preparation before obesity surgery, making the procedure safer and easier for surgeons.
What could go wrong: This is a small, early-stage study focused on safety and tolerance, not on long-term weight loss. The diet may cause side effects like low blood counts or muscle weakness.

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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 200 people

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

Started

Oct 2023

Expected to finish

Mar 2027

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 65 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: * Patient eligible for bariatric surgery (according to HAS criteria) whose sleeve gastrectomy is scheduled * Patient with morbid obesity (BMI ≥ 40) * Age ≥ 18 years and ≤ 65 years * Haemoglobinemia ≥ 12 g/dL in men and ≥ 11 g/dL in women * Patient speaking and understanding French * Adult having read and understood the information letter and signed the consent form * Woman of childbearing age with effective / very effective contraception (Cf. CTFG) (estrogen-progestin or intrauterine device or tubal ligation) prior to surgery and a negative -HCG blood pregnancy test at inclusion, for the duration of the study * Postmenopausal woman: confirmatory diagnosis (non-medically induced amenorrhoea for at least 12 months prior to the inclusion visit) * Patient affiliated with, or beneficiary of a social security (health insurance) category Exclusion Criteria: * Contraindication to bariatric surgery detected during the preoperative assessment * Medical contraindication to a restrictive diet * Type I or II insulin-requiring diabetes * Severe renal insufficiency defined by a blood filtration rate \< 30 mL/min * Person wearing a pacemaker or any other implant with the same functions (cochlear implant, bladder battery, etc.) * Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / sub-guardianship or curatorship * A history of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol or to prevent him/her from giving informed consent

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Obesity, Abdominal

As listed by the trial registrant

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

Bariatric surgery candidate Diet, healthy Obesity, visceral

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

3 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Pre-Surgery diet could shrink liver and boost safety for obesity patients

What the study statuses mean