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NCT05683730: TONIC

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

Recruiting now NA Last updated 8 June 2023
What this trial tests

NA trial testing Intermittent caloric restriction in Crohn's Disease in 174 participants. Currently enrolling.

Timeline
18 April 2023
Primary endpoint
1 July 2026
1 August 2027

Quick facts

Lead sponsorCentral Hospital, Nancy, France
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeother
Enrollment174
Start date18 April 2023
Primary completion1 July 2026
Estimated completion1 August 2027
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Central Hospital, Nancy, France

Who can join

Adults 18 to 65, any sex, with Crohn's Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Intermittent caloric restriction

Trials testing the same drug.

Other recruiting trials for Crohn's Disease

Currently open trials in the same condition.

Other Central Hospital, Nancy, France trials

Trials by the same sponsor.

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Data sources for this page

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