Diet before surgery may cut pain and opioid use, new trial hopes to prove

NCT ID NCT04219956

Symptom relief Sponsor: Nantes University Hospital Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether eating a diet very low in polyamines (natural compounds found in many foods) for a week before and after major abdominal surgery can lower pain levels. Researchers will compare pain scores and painkiller use in 278 adults who either follow the special diet or eat normally. The goal is to see if this simple dietary change can reduce the need for strong pain medications like morphine.

What this could mean

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

Active substance: polyamine-deficient diet
What this could lead to: If it works, this diet could offer a simple, drug-free way to reduce pain and opioid use after major abdominal surgery.
What could go wrong: This is an early-stage trial with no prior proof that a low-polyamine diet affects pain. The diet is restrictive and may be hard to follow. Results may not apply to other surgeries.

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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 278 people

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

Started

Feb 2020

Expected to finish

Nov 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 years and older

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: * Adult (\>18 years) * Indication for a " major " abdominal surgery as second surgical procedure : cure of eventration and restoration of digestive continuity * Intended Use of a Patient Controlled Morphine Pump (PCA) postoperatively or taking oral opioids * Possible follow-up during 7 months (post-operative consultation at 1 month and 6 months only if postoperative pain or complications) * Written informed consent form obtained from the patient * Affiliated to the social security Exclusion Criteria: * Pregnant women * Minor, adult under guardianship or benefiting from a legal protection * Oncological surgery * Surgery not painful (cholecystectomy, hernia, thyroidectomy, bariatric surgery) * Drug addicts patients, or under opiate dependency * Chronic pain patients (pain over 3 months) * Patients in nursing home or convalescence home (diet non possible in institution) * Planned hospitalisation before the intervention (during the 7 days before the surgery) * Severe undernutrition defined by the HAS criteria (weight loss \> 10% in 1 month and/or \> 15% in 6 months, albumin at inclusion \<15g/l) * Patient refusing the possibility to change his eating habits * Oral feeding impossible preoperatively * Patient not able to express himself on their pain (silent, …) * Decompensated psychiatric pathologies (severe depression syndrome,…) * Patient unable to understand the protocol and/or to give his informed consent

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Conditions

The condition(s) this trial relates to.

allergic disease gastroschisis Pain, Postoperative

As listed by the trial registrant

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

Digestive system surgical procedures

How to take part

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

The places running it

4 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.

Diet before surgery may cut pain and opioid use, new trial hopes to prove

What the study statuses mean