Crohn's DiseaseTONICNCT05683730
Intermittent Caloric Restriction in Patients With Mild to Moderate Crohn's Disease
A study testing Intermittent caloric restriction in people with Crohn's Disease, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Intermittent caloric restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteFrance
- Study dates
- 18 Apr 2023to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHRU of Nancy
Vandœuvre-lès-Nancy, CHRU de Nancy, 54511
CARON Bénédicte, MD, 0383155580, b.caron@chru-nancy.fr
LUDIVINE ODOUL, 0383155580, l.odoul@chru-nancy.fr
About this study
Official title: Intermittent Caloric Restriction in Patients With Mild to Moderate Crohn's Disease: A Randomized, Open-label, Controlled Trial
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.
Read more
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.
- Conditions
- Crohn's Disease
- Being tested
- Intermittent caloric restriction
- Keywords
- intermittent caloric restriction, Crohn's disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent caloric restrictionOther
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
| Study group | Role | What they receive |
|---|---|---|
| Intermittent caloric restriction | Experimental | Intermittent caloric restriction during 16 weeks. Receives: Other: Intermittent caloric restriction |
| Routine practice | No intervention | Routine practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 16
Secondary outcomes (13)
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
Measured: week 16
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
Measured: week 16
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
Measured: week 16
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
Measured: week 16
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.
Measured: week 16
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.
Measured: week 16
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.
Measured: week 16
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)
Measured: week 16
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
Measured: week 16
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)
Measured: weeks 4;8;12 and 16
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
Measured: week 16
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.
Measured: week 16
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.
Measured: 48 hours after intermittent caloric restriction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start18 Apr 2023
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CARON Bénédicte, Central Hospital, Nancy, France
- Investigators
- CARON Bénédicte, MD, Principal investigator, CHRU of Nancy, Hepatogastroenterology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683730
- Sponsor's protocol ID
- 2022-A02169-34
- Acronym
- TONIC
- Status last verified
- Jun 2023
- First submitted
- 20 Dec 2022
- Last updated
- 8 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34739863Jiang 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.
PubMed 33801883
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Caloric Restriction in Patients With Mild to Moderate Crohn's Disease: A Randomized, Open-label, Controlled Trial
- ClinicalTrials.gov ID
- NCT05683730
- Acronym / sponsor ID
- TONIC / 2022-A02169-34
- Conditions
- Crohn's Disease
- Keywords
- intermittent caloric restriction, Crohn's disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent caloric restriction | Experimental | Other: Intermittent caloric restrictionIntermittent caloric restriction during 16 weeks. |
| Routine practice | No intervention | –Routine practice |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent caloric restrictionIntermittente 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 | Other | Intermittent caloric restriction |
Primary outcome
Intestinal inflammation
Time frame: week 16
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.
13 secondary outcomes
Induction of a clinical response
Time frame: week 16
Induction of a clinical remission
Time frame: week 16
Induction of a biological remission
Time frame: week 16
Induction of a radiological response
Time frame: week 16
Improving quality of life
Time frame: week 16
Improving work productivity
Time frame: week 16
Improving fatigue
Time frame: week 16
Improving functional disability
Time frame: week 16
Improving anxiety disorder
Time frame: week 16
Evaluate the safety of intermittent caloric restriction in patients with mild to moderate with mild to moderate CD.
Time frame: weeks 4;8;12 and 16
Evaluate compliance of intermittent caloric restriction during 16 weeks in patients with with mild to moderate CD.
Time frame: week 16
Determine the level of patient satisfaction with intermittent caloric restriction
Time frame: week 16
Estimate, in the experimental arm, the prevalence of compensatory hyperphagia after intermittent caloric restriction
Time frame: 48 hours after intermittent caloric restriction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Background: PubMed 34739863Yanai 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.
- Background: PubMed 33801883Jiang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
CARON Bénédicte, MD principal investigator
CHRU of Nancy, Hepatogastroenterology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent caloric restriction in people with Crohn's Disease, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CARON Bénédicte, MD (0383155580, b.caron@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal inflammation (time frame: week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05683730, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.