Clinical Trial

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

Study acronym: TONIC
Recruiting
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Record status
This record was last updated June 8, 2023 (before its estimated July 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-01-04.
Status change: Not Yet Recruiting → Recruiting 2023-06-07
Trial Details
NCT Number NCT05683730
Lead Sponsor Central Hospital, Nancy, France
Conditions Crohn's Disease
Enrollment 174 participants
Start Date 2023-04-18
Primary Completion 2026-07-01 (estimated)
Study Completion 2027-08-01 (estimated)
Updated on ClinicalTrials.gov 2023-06-08