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Timed Eating and Modified Mediterranean Diet in Inflammatory Bowel Disease

Published: 02/07/2024

General Information:

Study Objective

To our knowledge, the use of a timed modified Mediterranean diet (combining the Mediterranean diet with timed eating) has not been previously investigated in humans. We hypothesise that combining timed eating and the Mediterranean diet will improve inflammation and gut leakiness in patients with IBD as compared to the Mediterranean diet by itself and with no intervention. 

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Eligibility:

Age
Adult (18+)
Gender
Female
Male
Disease Type
Crohn's Disease
Severity
Mild
Moderate
Severe
Eligibility Criteria

Inclusion criteria:  

- Adult patients (>18 years) 

- Diagnosis of Crohn’s Disease 

- Inactive disease based on our screening questionnaire  

- Subclinical inflammation based on screening stool collection analysis  

- Not currently following the Mediterranean diet based on screening diet questionnaire 

- BMI 18.5-40 

- Access to internet, an e-mail address and a smart phone 

  

Exclusion criteria: 

- Shift workers 

- Pregnancy  

- Hospitalized patients 

- Changes in CD treatment in the 8 weeks prior to study initiation 

- Celiac disease 

- Short gut syndrome 

- History of Roux-en-Y gastric bypass surgery 

- Allergies to nuts or olive oils 

- Patients on specific diet for other (health) reasons 

- Patients already on a Mediterranean diet or following intermittent fasting/timed eating 

- Active CD, as evidenced by high disease activity index >150 or Harvey Bradshaw score of >4 

- Fecal calprotectin of <50 or >250 

- BMI >35 

- Antibiotic use in the last 4 weeks prior to enrollment 

- If on any prebiotic/probiotics, willingness to stop using 2 week prior to enrollment and for the duration of the study      

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Study Details:

This is an 8-week study where participants will be randomly assigned to one of 3 groups: control group (no intervention), modified Mediterranean diet, or timed eating + modified Mediterranean diet. Throughout the study, participants will complete a series of questionnaires and visit our clinic office three times for an 8-hour fasted blood draw and to provide stool and urine samples. Participants in the diet groups will receive virtual consultations with a registered dietitian, along with educational materials, and those in the control group will have the opportunity to meet with the dietician when a slot becomes available. 

 

Description of treatment or intervention (mechanism of action): 

This is a diet intervention where participants will be randomly assigned to receive a modified Mediterranean diet, timed eating + modified Mediterranean diet, or no intervention. Participants will be counseled on how to follow their diet intervention during the 8 weeks. 

Patient Participation Requirements: 

Participants need to complete questionnaires that relate to their diet, health, Crohn's symptoms, sleep, fatigue, and medication usage every other week. We do ask participants to provide stool and urine specimens. All materials and instructions are provided to participants and those can be shipped to us. Blood draws are 8 hours fasted.   

Possible risks and side effects: 

We do not foresee any risks as we assess participants for any possible allergens. 

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Contact Information:

Site Locations

Rush University Medical Center 1725 W. Harrison Street, Suite 207 Chicago, Illinois 60612
Michelle Villanueva
312-942-8927
[email protected]
Language: English
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