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NCT Number: NCT05683730

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

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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intermittent caloric restriction

Other

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 outcomes

  1. 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.

Secondary outcomes

  1. Induction of a clinical response

    Time frame: week 16

    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

  2. Induction of a clinical remission

    Time frame: week 16

    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

  3. Induction of a biological remission

    Time frame: week 16

    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

  4. Induction of a radiological response

    Time frame: week 16

    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

  5. Improving quality of life

    Time frame: week 16

    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.

  6. Improving work productivity

    Time frame: week 16

    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.

  7. Improving fatigue

    Time frame: week 16

    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.

  8. Improving functional disability

    Time frame: week 16

    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)

  9. Improving anxiety disorder

    Time frame: week 16

    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

  10. 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

    Percentage of adverse event related to intermittent caloric restriction (fatigue; nausea; headache, dizziness, hypotension, irritability, capacity reduced to concentrating, undernutrition/sarcopenia)

  11. Evaluate compliance of intermittent caloric restriction during 16 weeks in patients with with mild to moderate CD.

    Time frame: week 16

    Percentage of patient compliance measured by for example a intermittent caloric restriction during at least 21 days on the 16 weeks of the study

  12. Determine the level of patient satisfaction with intermittent caloric restriction

    Time frame: week 16

    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.

  13. Estimate, in the experimental arm, the prevalence of compensatory hyperphagia after intermittent caloric restriction

    Time frame: 48 hours after intermittent caloric restriction

    Percentage of patients having a compensatory hyperphagia after 2 days of intermittent caloric restriction.

Study contacts

Contact information is provided by the study sponsor or research team.

CARON Bénédicte, MD

CONTACT

[email protected]

0383155580

Ludivine ODOUL, CPM

CONTACT

[email protected]

0383155580

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Intermittent Caloric Restriction in Patients With Mild to Moderate Crohn's Disease: A Randomized, Open-label, Controlled Trial

Acronym: TONIC

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jan 13, 2023
Registry last updated
Jun 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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