Intermittent Caloric Restriction in Patients With Mild to Moderate Crohn's Disease (TONIC)

Central Hospital, Nancy, France

Status

Enrolling

Conditions

Crohn's Disease

Treatments

Other: Intermittent caloric restriction

Study type

Interventional

Funder types

Other

Identifiers

NCT05683730

2022-A02169-34

Details and patient eligibility

About

Crohn's disease (CD) is a chronic inflammatory disease of the gastrointestinal (GI) tract. CD is a common inflammatory bowel disease (IBD), frequent (150,000 patients in France and 1.5 million in Europe), disabling and incurable. The environmental factors, and in particular diet, play a major role in the pathogenesis of CD. The prevalence of CD is steadily increasing in highly industrialized countries, where the Western diet rich in saturated fats and refined sugars, is blamed for this to explain this true pandemic. On the other hand, enteral nutrition, exclusive or partial, is known to be effective in the initial treatment of CD, especially in pediatrics.

There are a number of evidence in favor of a nutritional management nutritional management of caloric restriction during inflammatory diseases such as psoriasis and rheumatoid arthritis,whose physiopathology is similar to that of IBD.

To date, and despite patient concern, there is no consensus nutritional in the management of CD to influence the natural course of the disease.

The investigators have decided to initiate a clinical study to evaluate for the first time the efficacy, acceptability and safety of intermittent caloric restriction in patients with CD.

Enrollment

174 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.