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

Primary Purpose

Crohn's Disease

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Intermittent caloric restriction
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Crohn's Disease focused on measuring intermittent caloric restriction, Crohn's disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • CHRU of NancyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intermittent caloric restriction

Routine practice

Arm Description

Intermittent caloric restriction during 16 weeks.

Routine practice

Outcomes

Primary Outcome Measures

Intestinal inflammation
Evaluate the effectiveness of personalized nutritional management of intermittent caloric restriction during 16 weeks on the level of intestinal inflammation (induction of of a biological response) in patients with mild to moderate CD mild to moderate. The effectiveness will be evaluated in each group by a biological response change, that is to say a decrease at least 50% of calprotectin fecal level.

Secondary Outcome Measures

Induction of a clinical response
Evaluate the impact of personalized nutritional management of intermittent caloric restriction during 16 weeks on Crohn's Disease Activity Index (CDAI) that is to say change by al least 100 points. The following cut-offs correlate with level of disease activity: Non-active disease: CDAI < 150 Mild disease activity: CDAI >= 150 and <220 Moderate disease activity: CDAI >= 220 and <450 Severe disease activity: CDAI > 450
Induction of a clinical remission
Evaluate the impact of personalized nutritional management of intermittent caloric restriction during 16 weeks on clinical remission, that is to say Crohn's Disease Activity Index (CDAI) < 150 The following cut-offs correlate with level of disease activity: Non-active disease: CDAI < 150 Mild disease activity: CDAI >= 150 and <220 Moderate disease activity: CDAI >= 220 and <450 Severe disease activity: CDAI > 450
Induction of a biological remission
Evaluate the impact of personalized nutritional management of intermittent caloric restriction during 16 weeks on biological remission that is to say fecal calprotection < 250 µg/g
Induction of a radiological response
Evaluate the impact of personalized nutritional management of intermittent caloric restriction during 16 weeks on radiological response that is to say change of 50% of Nancy score measured by magnetic resonance imaging (MRI) Total MRI score: 0 at 36
Improving quality of life
Evaluated by short-Inflammatory Bowel Disease Questionnaire (short-IBDQ) short-IBDQ is a 10-items measure that assesses self-reported quality of life. Total score ranges from 10 to 70. Higher the score is better life quality is.
Improving work productivity
Evaluated by Work Productivity and Activity Impairment Questionnaire (WPAI) WPAI questions measure the effect of patients health problems (any physical or emotional problem or symptom) on their ability to work and perform regular activites.
Improving fatigue
Evaluated by Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) FACIT-F is a 40-items measure that assesses self-reported fatigue and its impact upon daily activities and function.
Improving functional disability
Evaluated by Inflammatory Bowel Disease - Disability Index (IBD-DI) IBD-DI is a 14-items measure that assesses self-reported disability. It ranges from 0-100: 0-20 (no disability), 20-35 (mild disability), 35-50 (moderate disability) and 50-100 (severe disability)
Improving anxiety disorder
Evaluated by Generalized Anxiety Disorder (GAD-7) The following cut-offs correlate with level of anxiety severity: Score 0-4: Minimal Anxiety Score 5-9: Mild Anxiety Score 10-14: Moderate Anxiety Score greater than 15: Severe Anxiety
Evaluate the safety of intermittent caloric restriction in patients with mild to moderate with mild to moderate CD.
Percentage of adverse event related to intermittent caloric restriction (fatigue; nausea; headache, dizziness, hypotension, irritability, capacity reduced to concentrating, undernutrition/sarcopenia)
Evaluate compliance of intermittent caloric restriction during 16 weeks in patients with with mild to moderate CD.
Percentage of patient compliance measured by for example a intermittent caloric restriction during at least 21 days on the 16 weeks of the study
Determine the level of patient satisfaction with intermittent caloric restriction
Evaluated by Likert scale at 4 items ad-hoc 4 point likert scale for the frequency; assign each response a point value from 1 to 4.
Estimate, in the experimental arm, the prevalence of compensatory hyperphagia after intermittent caloric restriction
Percentage of patients having a compensatory hyperphagia after 2 days of intermittent caloric restriction.

Full Information

First Posted
December 20, 2022
Last Updated
June 7, 2023
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT05683730
Brief Title
Intermittent Caloric Restriction in Patients With Mild to Moderate Crohn's Disease
Acronym
TONIC
Official Title
Intermittent Caloric Restriction in Patients With Mild to Moderate Crohn's Disease: A Randomized, Open-label, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 18, 2023 (Actual)
Primary Completion Date
July 1, 2026 (Anticipated)
Study Completion Date
August 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
intermittent caloric restriction, Crohn's disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
174 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intermittent caloric restriction
Arm Type
Experimental
Arm Description
Intermittent caloric restriction during 16 weeks.
Arm Title
Routine practice
Arm Type
No Intervention
Arm Description
Routine practice
Intervention Type
Other
Intervention Name(s)
Intermittent caloric restriction
Intervention Description
Intermittente caloric restriction: st month: restriction of 50% of the caloric intake previously determined by the dietician 1 day per week nd month: restriction of 50% of the caloric intake 2 days per week rd month: restriction of 60% of the caloric intake 2 days per week th month: restriction of 75% of the caloric intake 2 days per week
Primary Outcome Measure Information:
Title
Intestinal inflammation
Description
Evaluate the effectiveness of personalized nutritional management of intermittent caloric restriction during 16 weeks on the level of intestinal inflammation (induction of of a biological response) in patients with mild to moderate CD mild to moderate. The effectiveness will be evaluated in each group by a biological response change, that is to say a decrease at least 50% of calprotectin fecal level.
Time Frame
week 16
Secondary Outcome Measure Information:
Title
Induction of a clinical response
Description
Evaluate the impact of personalized nutritional management of intermittent caloric restriction during 16 weeks on Crohn's Disease Activity Index (CDAI) that is to say change by al least 100 points. The following cut-offs correlate with level of disease activity: Non-active disease: CDAI < 150 Mild disease activity: CDAI >= 150 and <220 Moderate disease activity: CDAI >= 220 and <450 Severe disease activity: CDAI > 450
Time Frame
week 16
Title
Induction of a clinical remission
Description
Evaluate the impact of personalized nutritional management of intermittent caloric restriction during 16 weeks on clinical remission, that is to say Crohn's Disease Activity Index (CDAI) < 150 The following cut-offs correlate with level of disease activity: Non-active disease: CDAI < 150 Mild disease activity: CDAI >= 150 and <220 Moderate disease activity: CDAI >= 220 and <450 Severe disease activity: CDAI > 450
Time Frame
week 16
Title
Induction of a biological remission
Description
Evaluate the impact of personalized nutritional management of intermittent caloric restriction during 16 weeks on biological remission that is to say fecal calprotection < 250 µg/g
Time Frame
week 16
Title
Induction of a radiological response
Description
Evaluate the impact of personalized nutritional management of intermittent caloric restriction during 16 weeks on radiological response that is to say change of 50% of Nancy score measured by magnetic resonance imaging (MRI) Total MRI score: 0 at 36
Time Frame
week 16
Title
Improving quality of life
Description
Evaluated by short-Inflammatory Bowel Disease Questionnaire (short-IBDQ) short-IBDQ is a 10-items measure that assesses self-reported quality of life. Total score ranges from 10 to 70. Higher the score is better life quality is.
Time Frame
week 16
Title
Improving work productivity
Description
Evaluated by Work Productivity and Activity Impairment Questionnaire (WPAI) WPAI questions measure the effect of patients health problems (any physical or emotional problem or symptom) on their ability to work and perform regular activites.
Time Frame
week 16
Title
Improving fatigue
Description
Evaluated by Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) FACIT-F is a 40-items measure that assesses self-reported fatigue and its impact upon daily activities and function.
Time Frame
week 16
Title
Improving functional disability
Description
Evaluated by Inflammatory Bowel Disease - Disability Index (IBD-DI) IBD-DI is a 14-items measure that assesses self-reported disability. It ranges from 0-100: 0-20 (no disability), 20-35 (mild disability), 35-50 (moderate disability) and 50-100 (severe disability)
Time Frame
week 16
Title
Improving anxiety disorder
Description
Evaluated by Generalized Anxiety Disorder (GAD-7) The following cut-offs correlate with level of anxiety severity: Score 0-4: Minimal Anxiety Score 5-9: Mild Anxiety Score 10-14: Moderate Anxiety Score greater than 15: Severe Anxiety
Time Frame
week 16
Title
Evaluate the safety of intermittent caloric restriction in patients with mild to moderate with mild to moderate CD.
Description
Percentage of adverse event related to intermittent caloric restriction (fatigue; nausea; headache, dizziness, hypotension, irritability, capacity reduced to concentrating, undernutrition/sarcopenia)
Time Frame
weeks 4;8;12 and 16
Title
Evaluate compliance of intermittent caloric restriction during 16 weeks in patients with with mild to moderate CD.
Description
Percentage of patient compliance measured by for example a intermittent caloric restriction during at least 21 days on the 16 weeks of the study
Time Frame
week 16
Title
Determine the level of patient satisfaction with intermittent caloric restriction
Description
Evaluated by Likert scale at 4 items ad-hoc 4 point likert scale for the frequency; assign each response a point value from 1 to 4.
Time Frame
week 16
Title
Estimate, in the experimental arm, the prevalence of compensatory hyperphagia after intermittent caloric restriction
Description
Percentage of patients having a compensatory hyperphagia after 2 days of intermittent caloric restriction.
Time Frame
48 hours after intermittent caloric restriction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CARON Bénédicte, MD
Phone
0383155580
Email
b.caron@chru-nancy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Ludivine ODOUL, CPM
Phone
0383155580
Email
l.odoul@chru-nancy.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CARON Bénédicte, MD
Organizational Affiliation
CHRU of Nancy, Hepatogastroenterology Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU of Nancy
City
Vandoeuvre Les Nancy
State/Province
CHRU De Nancy
ZIP/Postal Code
54511
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CARON Bénédicte, MD
Phone
0383155580
Email
b.caron@chru-nancy.fr
First Name & Middle Initial & Last Name & Degree
LUDIVINE ODOUL
Phone
0383155580
Email
l.odoul@chru-nancy.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
34739863
Citation
Yanai H, Levine A, Hirsch A, Boneh RS, Kopylov U, Eran HB, Cohen NA, Ron Y, Goren I, Leibovitzh H, Wardi J, Zittan E, Ziv-Baran T, Abramas L, Fliss-Isakov N, Raykhel B, Gik TP, Dotan I, Maharshak N. The Crohn's disease exclusion diet for induction and maintenance of remission in adults with mild-to-moderate Crohn's disease (CDED-AD): an open-label, pilot, randomised trial. Lancet Gastroenterol Hepatol. 2022 Jan;7(1):49-59. doi: 10.1016/S2468-1253(21)00299-5. Epub 2021 Nov 2.
Results Reference
background
PubMed Identifier
33801883
Citation
Jiang Y, Jarr K, Layton C, Gardner CD, Ashouri JF, Abreu MT, Sinha SR. Therapeutic Implications of Diet in Inflammatory Bowel Disease and Related Immune-Mediated Inflammatory Diseases. Nutrients. 2021 Mar 10;13(3):890. doi: 10.3390/nu13030890.
Results Reference
background

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

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