Intermittent caloric restriction for patients with mild to moderate Crohn's disease

Intermittent Caloric Restriction in Patients With Mild to Moderate Crohn's Disease: A Randomized, Open-label, Controlled Trial

This study is testing if a special eating plan that limits calories on certain days can help people with mild to moderate Crohn's disease feel better and manage their symptoms.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 174 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Central Hospital, Nancy, France (Academic / other)
• Locations: 1 site (Vandœuvre-lès-Nancy, CHRU de Nancy)
• Trial ID: NCT05683730 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of intermittent caloric restriction on patients diagnosed with mild to moderate Crohn's disease, a chronic inflammatory condition of the gastrointestinal tract. The study aims to explore how dietary management, specifically caloric restriction, can influence the disease's progression and symptoms. Participants will adhere to a structured intermittent caloric restriction plan over a 16-week period while maintaining stable medical treatment for their condition. The trial seeks to fill the gap in nutritional management consensus for Crohn's disease, which is increasingly relevant given the rising prevalence of the condition in industrialized nations.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a confirmed diagnosis of mild to moderate Crohn's disease and stable medical treatment.

Not a fit: Patients with severe Crohn's disease, significant weight loss, or those with eating disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel dietary management strategy to improve symptoms and quality of life for patients with Crohn's disease.

How similar studies have performed: While there is evidence supporting nutritional management in similar inflammatory conditions, this specific approach to Crohn's disease is relatively novel and untested.

Eligibility criteria

Inclusion Criteria:

* Patients between 18 to 65 years old
* Established diagnosis of Crohn's disease with a minimum disease duration of 3 months
* Patient with mild to moderate Crohn's disease defined by a fecal calprotectin ≥ 250 μg/g and a CDAI score between 150 to 300
* Medical treatment of Crohn's disease stable for at least 3 months
* Patient compliant with an intermittent caloric restriction during 16 weeks
* Person affiliated to or beneficiary of a social security plan
* Person informed about study organization and having signed the informed consent

Exclusion Criteria:

* Patient with a BMI \< 18.5kg/m2
* Patient having a weight loss of 5% the first month and 10% during the first 6 months
* Patient with active ano-perineal lesions
* Patient with an ostomy
* Patient with eating disorders (anorexia, bulimia)
* Person referred in articles L.1121-5, L. 1121-7 and L.1121-8 of the Public Health Code:

  * Pregnant, parturient or breastfeeding woman
  * Minor person (non-emancipated)
  * Adult person under legal protection (any form of public guardianship)
  * Adult person incapable of giving consent and not under legal protection
* Person deprived of liberty for judicial or administrative decision, person under psychiatric care as referred in articles L. 3212-1 and L. 3213-1.

Where this trial is running

Vandœuvre-lès-Nancy, CHRU de Nancy

• CHRU of Nancy — Vandœuvre-lès-Nancy, CHRU de Nancy, France (Recruiting)

Study contacts

• Principal investigator: CARON Bénédicte, MD — CHRU of Nancy, Hepatogastroenterology Department
• Study coordinator: CARON Bénédicte, MD

Conditions Crohn's Disease; intermittent caloric restriction; Crohn's disease