Crohn's Disease (CD)TRF-CDNCT04271748
The Impact of Time Restricted Feeding in Crohn's Disease
A study testing Time Restricted Feeding in people with Crohn's Disease (CD), run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
Time-restricted feeding (TRF) is a dietary regimen involving the consumption of food and liquids within a defined time window with or without additional restriction on dietary composition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease (CD)
- What is being tested?
- Time Restricted Feeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2021to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects has active Crohn's disease of the ileum and/or colon. The diagnosis should be confirmed by endoscopic or radiological evidence.
- Active inflammation on colonoscopy performed as evidenced by an SES-CD ≥ 6 (or ≥ 4 for isolated ileal disease) OR C-Reactive protein ≥ 1.0 mg/L OR fecal calprotectin ≥ 250 μg/g. Any or all of these results must be from within 180 days of study entrance.
- Subject should have BMI of >18.5 and <40
Who cannot join
- Subjects who decline to provide informed consent
- Subject with a history of an eating disorder, major gastrointestinal surgery within the past 3 months.
- Subject with a history of antibiotic use within 4 weeks.
- Subject with a history of bowel obstruction within the past 12 months
- Subject with a history of diabetes requiring medication
- Subject who is currently pregnant or breastfeeding will be excluded
- Subjects with current antibiotic use. In order to participate, subjects will be required to have a 2-week wash-out period.
Trial locations and contacts
1 site in 1 country.
About this study
Time-restricted feeding (TRF) is a dietary regimen involving the consumption of food and liquids within a defined time window with or without additional restriction on dietary composition. TRF has been associated with improvements in inflammation, host metabolism, autophagy, gut microbial composition, and gut permeability. Crohn's disease is an inflammatory bowel disease of unknown etiology that likely results from a combination of genetic and environmental factors. This proposed study will test the hypothesis that a time-restricted feeding regimen will improve clinical outcomes and favorably influence the gut microbiome in patients with active Crohn's disease. If time-restricted fasting proves beneficial to this patient population then it will pave the way for larger, prospective studies and clinical trials.
- Conditions
- Crohn's Disease (CD)
- Being tested
- Time Restricted Feeding
- Keywords
- Fasting, Time Restricted Feeding, Intermittent Fasting, Inflammatory Bowel Diseases (IBD), IBD, CD
- Medical subject headings
- Crohn Disease, Fasting, Intermittent Fasting, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time Restricted FeedingOther
Also called Intermittent Fasting
The counseling on the regimen will involve instructing the subjects on study compliance and fasting times. Subjects will be instructed to choose an eight-hour eating window (e.g., 11:00am - 7:00pm) during which the patient will be able to eat his/her normal diet. During the 16-hour fasting window (e.g., 7:00pm - 11:00am), the participant will be able to drink regular water and black coffee.
| Study group | Role | What they receive |
|---|---|---|
| Time Restricted Feeding | Experimental | Subjects will be required to fast for 16 consecutive hours daily for 4 weeks. The registered dietitian will provide subjects counseling on the intermittent fasting regimen. Receives: Other: Time Restricted Feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient reported outcomes as measured by Patient Recorded Outcome 2 (PRO2) scores.
This will be measured to assess clinical response as determined by a reduction of either 8 or more points or a total PRO2 score of less than or equal to 8 points. The PRO2 score scale ranges from a score of 0 as the minimum and has no maximum limit. A score below 8 is considered remission; a score less than 14 is considered mild; and a score greater than 34 is considered severe.
Measured: Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet
Change in Inflammatory Markers as measured by blood C-reactive protein (CRP).
This will be measured to assess clinical response as determined by a reduction of 50% or more from baseline or normalization of the CRP level results.
Measured: Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet
Change in inflammatory markers as measured by fecal calprotectin lab results
This will be measured to assess clinical changes as determined by a reduction of 50% or more from baseline or normalization of the calprotectin levels results.
Measured: Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet
Secondary outcomes (2)
Change in taxonomic composition of the gut microbiome as measured by Polymerase Chain Reaction (PCR) analysis.
This will be measured to assess the impact of time restricted feeding on intestinal microbiota composition.
Measured: Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet
Markers of systemic peripheral blood immunity as measured by Mass Cytometry by Time-Of-Flight (CyTOF) analysis.
This will be measured to assess the effect of time restricted feeding on immune cell composition.
Measured: Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start14 Jan 2021
- Primary completion16 Aug 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Crohn's Disease (CD)Studies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- The Kenneth Rainin Foundation
- Responsible party
- Sponsor
- Investigators
- Dana J Lukin, MD, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271748
- Sponsor's protocol ID
- 19-11021081
- Acronym
- TRF-CD
- Status last verified
- Jan 2023
- First submitted
- 13 Feb 2020
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Celiberto LS, Graef FA, Healey GR, Bosman ES, Jacobson K, Sly LM, Vallance BA. Inflammatory bowel disease and immunonutrition: novel therapeutic approaches through modulation of diet and the gut microbiome. Immunology. 2018 Sep;155(1):36-52. doi: 10.1111/imm.12939. Epub 2018 May 16.
PubMed 29693729Mattson MP, Longo VD, Harvie M. Impact of intermittent fasting on health and disease processes. Ageing Res Rev. 2017 Oct;39:46-58. doi: 10.1016/j.arr.2016.10.005. Epub 2016 Oct 31.
PubMed 27810402Patterson RE, Sears DD. Metabolic Effects of Intermittent Fasting. Annu Rev Nutr. 2017 Aug 21;37:371-393. doi: 10.1146/annurev-nutr-071816-064634. Epub 2017 Jul 17.
PubMed 28715993Nagai M, Noguchi R, Takahashi D, Morikawa T, Koshida K, Komiyama S, Ishihara N, Yamada T, Kawamura YI, Muroi K, Hattori K, Kobayashi N, Fujimura Y, Hirota M, Matsumoto R, Aoki R, Tamura-Nakano M, Sugiyama M, Katakai T, Sato S, Takubo K, Dohi T, Hase K. Fasting-Refeeding Impacts Immune Cell Dynamics and Mucosal Immune Responses. Cell. 2019 Aug 22;178(5):1072-1087.e14. doi: 10.1016/j.cell.2019.07.047.
PubMed 31442401Jordan S, Tung N, Casanova-Acebes M, Chang C, Cantoni C, Zhang D, Wirtz TH, Naik S, Rose SA, Brocker CN, Gainullina A, Hornburg D, Horng S, Maier BB, Cravedi P, LeRoith D, Gonzalez FJ, Meissner F, Ochando J, Rahman A, Chipuk JE, Artyomov MN, Frenette PS, Piccio L, Berres ML, Gallagher EJ, Merad M. Dietary Intake Regulates the Circulating Inflammatory Monocyte Pool. Cell. 2019 Aug 22;178(5):1102-1114.e17. doi: 10.1016/j.cell.2019.07.050.
PubMed 31442403MacLellan A, Moore-Connors J, Grant S, Cahill L, Langille MGI, Van Limbergen J. The Impact of Exclusive Enteral Nutrition (EEN) on the Gut Microbiome in Crohn's Disease: A Review. Nutrients. 2017 May 1;9(5):447. doi: 10.3390/nu9050447.
PubMed 28468301Suskind DL, Cohen SA, Brittnacher MJ, Wahbeh G, Lee D, Shaffer ML, Braly K, Hayden HS, Klein J, Gold B, Giefer M, Stallworth A, Miller SI. Clinical and Fecal Microbial Changes With Diet Therapy in Active Inflammatory Bowel Disease. J Clin Gastroenterol. 2018 Feb;52(2):155-163. doi: 10.1097/MCG.0000000000000772.
PubMed 28030510Khanna R, Zou G, D'Haens G, Feagan BG, Sandborn WJ, Vandervoort MK, Rolleri RL, Bortey E, Paterson C, Forbes WP, Levesque BG. A retrospective analysis: the development of patient reported outcome measures for the assessment of Crohn's disease activity. Aliment Pharmacol Ther. 2015 Jan;41(1):77-86. doi: 10.1111/apt.13001. Epub 2014 Oct 27.
PubMed 25348809
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Time Restricted Feeding in Crohn's Disease
- ClinicalTrials.gov ID
- NCT04271748
- Acronym / sponsor ID
- TRF-CD / 19-11021081
- Conditions
- Crohn's Disease (CD)
- Keywords
- Fasting, Time Restricted Feeding, Intermittent Fasting, Inflammatory Bowel Diseases (IBD), IBD, CD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- The Kenneth Rainin Foundation
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 16 Aug 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 17 Feb 2020 (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.
Time-restricted feeding (TRF) is a dietary regimen involving the consumption of food and liquids within a defined time window with or without additional restriction on dietary composition. TRF has been associated with improvements in inflammation, host metabolism, autophagy, gut microbial composition, and gut permeability. Crohn's disease is an inflammatory bowel disease of unknown etiology that likely results from a combination of genetic and environmental factors. This proposed study will test the hypothesis that a time-restricted feeding regimen will improve clinical outcomes and favorably influence the gut microbiome in patients with active Crohn's disease. If time-restricted fasting proves beneficial to this patient population then it will pave the way for larger, prospective studies and clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Time Restricted Feeding | Experimental | Other: Time Restricted FeedingSubjects will be required to fast for 16 consecutive hours daily for 4 weeks. The registered dietitian will provide subjects counseling on the intermittent fasting regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects has active Crohn's disease of the ileum and/or colon. The diagnosis should be confirmed by endoscopic or radiological evidence.
- Active inflammation on colonoscopy performed as evidenced by an SES-CD ≥ 6 (or ≥ 4 for isolated ileal disease) OR C-Reactive protein ≥ 1.0 mg/L OR fecal calprotectin ≥ 250 μg/g. Any or all of these results must be from within 180 days of study entrance.
- Subject should have BMI of >18.5 and <40
Key exclusion criteria (7 listed)
- Subjects who decline to provide informed consent
- Subject with a history of an eating disorder, major gastrointestinal surgery within the past 3 months.
- Subject with a history of antibiotic use within 4 weeks.
- Subject with a history of bowel obstruction within the past 12 months
- Subject with a history of diabetes requiring medication
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 |
|---|---|---|
| Time Restricted FeedingAlso: Intermittent FastingThe counseling on the regimen will involve instructing the subjects on study compliance and fasting times. Subjects will be instructed to choose an eight-hour eating window (e.g., 11:00am - 7:00pm) during which the patient will be able to eat his/her normal diet. During the 16-hour fasting window (e.g., 7:00pm - 11:00am), the participant will be able to drink regular water and black coffee. | Other | Time Restricted Feeding |
Primary outcome
Change in patient reported outcomes as measured by Patient Recorded Outcome 2 (PRO2) scores.
Time frame: Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet
This will be measured to assess clinical response as determined by a reduction of either 8 or more points or a total PRO2 score of less than or equal to 8 points. The PRO2 score scale ranges from a score of 0 as the minimum and has no maximum limit. A score below 8 is considered remission; a score less than 14 is considered mild; and a score greater than 34 is considered severe.
Change in Inflammatory Markers as measured by blood C-reactive protein (CRP).
Time frame: Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet
This will be measured to assess clinical response as determined by a reduction of 50% or more from baseline or normalization of the CRP level results.
Change in inflammatory markers as measured by fecal calprotectin lab results
Time frame: Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet
This will be measured to assess clinical changes as determined by a reduction of 50% or more from baseline or normalization of the calprotectin levels results.
2 secondary outcomes
Change in taxonomic composition of the gut microbiome as measured by Polymerase Chain Reaction (PCR) analysis.
Time frame: Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet
Markers of systemic peripheral blood immunity as measured by Mass Cytometry by Time-Of-Flight (CyTOF) analysis.
Time frame: Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Background: PubMed 29693729Celiberto LS, Graef FA, Healey GR, Bosman ES, Jacobson K, Sly LM, Vallance BA. Inflammatory bowel disease and immunonutrition: novel therapeutic approaches through modulation of diet and the gut microbiome. Immunology. 2018 Sep;155(1):36-52. doi: 10.1111/imm.12939. Epub 2018 May 16.
- Background: PubMed 27810402Mattson MP, Longo VD, Harvie M. Impact of intermittent fasting on health and disease processes. Ageing Res Rev. 2017 Oct;39:46-58. doi: 10.1016/j.arr.2016.10.005. Epub 2016 Oct 31.
- Background: PubMed 28715993Patterson RE, Sears DD. Metabolic Effects of Intermittent Fasting. Annu Rev Nutr. 2017 Aug 21;37:371-393. doi: 10.1146/annurev-nutr-071816-064634. Epub 2017 Jul 17.
- Background: PubMed 31442401Nagai M, Noguchi R, Takahashi D, Morikawa T, Koshida K, Komiyama S, Ishihara N, Yamada T, Kawamura YI, Muroi K, Hattori K, Kobayashi N, Fujimura Y, Hirota M, Matsumoto R, Aoki R, Tamura-Nakano M, Sugiyama M, Katakai T, Sato S, Takubo K, Dohi T, Hase K. Fasting-Refeeding Impacts Immune Cell Dynamics and Mucosal Immune Responses. Cell. 2019 Aug 22;178(5):1072-1087.e14. doi: 10.1016/j.cell.2019.07.047.
- Background: PubMed 31442403Jordan S, Tung N, Casanova-Acebes M, Chang C, Cantoni C, Zhang D, Wirtz TH, Naik S, Rose SA, Brocker CN, Gainullina A, Hornburg D, Horng S, Maier BB, Cravedi P, LeRoith D, Gonzalez FJ, Meissner F, Ochando J, Rahman A, Chipuk JE, Artyomov MN, Frenette PS, Piccio L, Berres ML, Gallagher EJ, Merad M. Dietary Intake Regulates the Circulating Inflammatory Monocyte Pool. Cell. 2019 Aug 22;178(5):1102-1114.e17. doi: 10.1016/j.cell.2019.07.050.
- Background: PubMed 28468301MacLellan A, Moore-Connors J, Grant S, Cahill L, Langille MGI, Van Limbergen J. The Impact of Exclusive Enteral Nutrition (EEN) on the Gut Microbiome in Crohn's Disease: A Review. Nutrients. 2017 May 1;9(5):447. doi: 10.3390/nu9050447.
- Background: PubMed 28030510Suskind DL, Cohen SA, Brittnacher MJ, Wahbeh G, Lee D, Shaffer ML, Braly K, Hayden HS, Klein J, Gold B, Giefer M, Stallworth A, Miller SI. Clinical and Fecal Microbial Changes With Diet Therapy in Active Inflammatory Bowel Disease. J Clin Gastroenterol. 2018 Feb;52(2):155-163. doi: 10.1097/MCG.0000000000000772.
- Background: PubMed 25348809Khanna R, Zou G, D'Haens G, Feagan BG, Sandborn WJ, Vandervoort MK, Rolleri RL, Bortey E, Paterson C, Forbes WP, Levesque BG. A retrospective analysis: the development of patient reported outcome measures for the assessment of Crohn's disease activity. Aliment Pharmacol Ther. 2015 Jan;41(1):77-86. doi: 10.1111/apt.13001. Epub 2014 Oct 27.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Dana J Lukin, MD, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time Restricted Feeding in people with Crohn's Disease (CD), run by Weill Medical College of Cornell University at 1 site in United States.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 31 Jan 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient reported outcomes as measured by Patient Recorded Outcome 2 (PRO2) scores. (time frame: Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet). The study lists 3 primary outcomes in all. 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 NCT04271748, which also lists 8 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 31 Jan 2023.