RecruitingNot ApplicableNCT05683730

Intermittent Caloric Restriction in 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


Sponsor

Central Hospital, Nancy, France

Enrollment

174 participants

Start Date

Apr 18, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a specific type of intermittent fasting (reducing calories on certain days) can help reduce inflammation and symptoms in people with mild to moderate Crohn's disease. **You may be eligible if...** - You are between 18 and 65 years old - You have a confirmed diagnosis of Crohn's disease for at least 3 months - Your Crohn's disease is currently mild to moderate (based on stool and symptom scoring) - Your medical treatment for Crohn's disease has been stable for at least 3 months - You are able and willing to follow a calorie-restricted eating plan for 16 weeks **You may NOT be eligible if...** - Your body mass index (BMI) is below 18.5 (underweight) - You have an ostomy (a surgical opening in the abdomen for waste) - You have active anal or perianal lesions - You have an eating disorder such as anorexia or bulimia - You are pregnant, breastfeeding, or a minor - You are under legal guardianship or unable to provide consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERIntermittent caloric restriction

Intermittente caloric restriction: 1. st month: restriction of 50% of the caloric intake previously determined by the dietician 1 day per week 2. nd month: restriction of 50% of the caloric intake 2 days per week 3. rd month: restriction of 60% of the caloric intake 2 days per week 4. th month: restriction of 75% of the caloric intake 2 days per week


Locations(1)

CHRU of Nancy

Vandœuvre-lès-Nancy, CHRU de Nancy, France

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NCT05683730


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