Crohn DiseaseCD-FastNCT05230160
Can Intermittent Fasting Induce Weight Loss and Improve Gut Health as Compared to Standard Medical Care in Patients With Obesity/High BMI and Crohn's Disease.
A study testing Intermittent Fasting in people with Crohn Disease, run by University of Calgary at 1 site in Canada.
Trial summary
Diet is a determinant of gut microbial diversity and composition and is recognized as a potential environmental trigger for IBD; for example, high-fat diets are associated with increased risk of CD in pre-clinical models, with effects mediated through dysbiosis and altered gut permeability. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Intermittent Fasting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2022to 30 Jun 2025
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 to ≤ 75 years of age;
- ileocolonic or colonic CD in clinical remission diagnosed through conventional definitions with a Harvey Bradshaw Index (HBI) < 5 within 3 months of recruitment;
- presence of inflammation using an FCP ≥ 250 µg/g or a CRP ≥ 5 mg/L;
- stable dosing of biologic agents and/or immunomodulators and/or oral or rectal 5-ASA, and no changes to medical management (including corticosteroid exposure) for at least 3 months prior to recruitment
- presence of overweight or obesity with BMI > 25 and a PG-SGA of class A.
Who cannot join
- upper gastrointestinal involvement CD, fistulizing disease;
- documented strictures based on sonographic findings or colonoscopy within the last year;
- > 1 small bowel resection;
- colectomy;
- presence of an ostomy;
- antibiotic use in past 3-months;
- pregnancy;
- corticosteroids in the last 3 months.
Trial locations and contacts
1 site in 1 country.
Canada1 site
TRW building, Foothills, University of Calgary
Calgary, Alberta, T2N 4Z6
About this study
Diet is a determinant of gut microbial diversity and composition and is recognized as a potential environmental trigger for IBD; for example, high-fat diets are associated with increased risk of CD in pre-clinical models, with effects mediated through dysbiosis and altered gut permeability.
Diet is also a potential non-pharmacological therapy for weight loss and for reducing the occurrence of disease flares and the reliance on dose escalation of biologic agents. Indeed, there is accumulating evidence for the role of diet in the treatment of CD, and diet-induced improvement of microbial dysbiosis is associated with induction of remission in pediatric patients with active CD.
Intermittent Fasting (IF) is a dietary intervention that involves periodic intervals of no or very limited energy intake. We want to determine the efficacy and feasibility of a 12-week IF(Intermittent Fasting) intervention to induce weight loss (by 1 BMI unit reduction), decrease biomarker inflammation and increase microbial functional diversity compared to standard medical management (SM) in a pilot study of individuals with overweight or obesity and CD in clinical remission with elevated biomarkers of inflammation, indicated by fecal calprotectin (FCP) > 250 µg/g or C-reactive protein (CRP) > 5 mg/L).
Read the detailed description
Objectives: To determine if a 12-week IF intervention compared to SM:
- Induces weight loss of at least 1 BMI unit.
- Reduces intestinal and systemic inflammation.
- Alters gut microbial community structure (beta-diversity) from baseline.
- Alters the adipokines and myokines leptin, adiponectin, IL-6, or irisin.
- Alters zonulin and serum levels of gastrointestinal hormones ghrehlin, glucagon-like peptide 1 (GLP-1), and glucagon-like peptide 2 (GLP-2).
- Alters body composition and whether changes in body composition have an effect on biomarkers of inflammation.
- Is a feasible and sustainable intervention for patients with CD.
Hypotheses: We hypothesize that, compared to SM, IF will:
- Induce at least a 1-unit decrease in BMI over the course of the intervention.
- Improve inflammatory markers of CD, demonstrated by a decrease in FCP by ≥ 50%, normalization of FCP to ≤ 100 µg/g, or a decrease in CRP to ≤ 5 mg/L.
- Alter gut microbial community structure (beta-diversity ) and lead to enrichment of bacterial species typically depleted in CD, such as Faecalibacterium prausnitzii and Roseburia hominus with concomitant decreases in Escherichia coli and overall Proteobacteria phylum abundance.
- Alter adipokines and myokines (leptin, adiponectin, IL-6, and irisin), zonulin and serum levels of gastrointestinal hormones (ghrehlin, GLP-1, and GLP-2).
- Alter body composition by decreasing VAT.
- Be a feasible and sustainable treatment option for patients with CD
Methods
Study Design:
The study is a 12-week pilot randomized controlled trial (RCT). Eligible participants (N=42) will be randomized 1:1 to either the IF or the SM control group. Patients from the University of Calgary IBD clinic will be enrolled in the RCT.
Screening:
The study RD will assess participants for malnutrition using the abridged patient-generated subjective global assessment (PG-SGA), a validated tool to determine malnutrition status in patients with chronic disease. The Nine Item Avoidant/Restrictive Food Intake Disorder screen33 will be completed to rule out avoidant and restrictive food behaviours that may increase the malnutrition risk of an IF intervention.
Inclusion criteria:
- ≥ 18 to ≤ 75 years of age; 2) ileocolonic or colonic CD in clinical remission diagnosed through conventional definitions with a Harvey Bradshaw Index (HBI) < 5 within 3 months of recruitment; 3) presence of inflammation using an FCP ≥ 250 µg/g or a CRP ≥ 5 mg/L; 4) stable dosing of biologic agents and/or immunomodulators and/or oral or rectal 5-ASA, and no changes to medical management (including corticosteroid exposure) for at least 3 months prior to recruitment; and 5) presence of overweight or obesity with BMI > 25 and a PG-SGA of class A.
Exclusion criteria:
- upper gastrointestinal involvement CD, fistulizing disease; 2) documented strictures based on sonographic findings or colonoscopy within the last year; 3) > 1 small bowel resection; 4) colectomy; 5) presence of an ostomy; 6) antibiotic use in past 3-months; 7) pregnancy; and 8) corticosteroids in the last 3 months.
- Conditions
- Crohn Disease
- Being tested
- Intermittent Fasting
- 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 FastingOther
Intermittent Fasting (IF) is a dietary intervention that involves periodic intervals of no or very limited energy intake. Fasting and feeding intervals vary and the practice of IF commonly consists of either a daily fast for 16 hours, a 24-hour fast on alternate days, or a fast two days per week on non-consecutive days.
For the study, the IF group will be asked to fast for 16 consecutive hours, 6 days per week. This means they will have an 8-hour eating window (e.g., eat from 10 a.m. to 6 p.m.) each day. They will be asked to eat the same types of food and the same amounts as usual, but only during the 8-hour eating window.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The IF group will fast for 16 consecutive hours on 6 days per week with an 8-hour eating window (e.g., eat from 10 a.m. to 6 p.m.). The IF group will consume their habitual diet in terms of food choices and energy intake, but only during the 8-hour and full-day non-fasting periods. An RD will meet virtually with participants in the IF group at baseline to teach them the fasting protocol and how to manage energy intake and hunger, as well as to reinforce the requirement to not change habitual dietary practices. The research coordinator will call patients every two weeks to assess for changes in medications, compliance with the fasting protocol, and symptoms (assessed monthly) using the modified HBI. Receives: Other: Intermittent Fasting |
| Standard Medical Care Group | No intervention | The control group will continue with their habitual dietary pattern. The research coordinator will call patients at baseline and every two weeks to assess for changes in medications and symptoms (assessed monthly) using the modified HBI. |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI-A decrease in BMI of at least 1 BMI unit over the course of the intervention: Change is being assessed
A measure of body fat based on height and weight
Measured: Baseline and Week 12
Fecal Calprotectin: Change is being assessed
FCP is a test used to detect inflammation in the colon and is associated with disease
Measured: Baseline and Week 12
C Reactive Protien: Change is being assessed
A protein the liver produces in the presence of inflammatory disease
Measured: Baseline and Week 12
Secondary outcomes (5)
24 hour ASA food recalls: Change is being assessed.
Assess diet quality
Measured: Baseline and week 12
Serum and fecal metabolomics: Change is being assessed
Metabolomics analysis provides a snapshot of an organism's current metabolite profile
Measured: Baseline and Week 12
Serum markers: Change is being assessed
Leptin, adiponectin, IL-6, irisin, zonulin, ghrehlin, GLP-1, and GLP-2
Measured: Baseline and week 12
Body Composition: Change is being assessed
Lean muscle mass, total fat mass, subcutaneous fat mass, and visceral fat mass will be assessed using DEXA, a gold standard test to determine body composition, differentiate proportion of lean muscle compared to fat mass, and distinguish between subcutaneous and VAT
Measured: Baseline and week 12
Fecal microbiome: Change is being assessed
Determined using shotgun metagenomic sequencing (Illumina NovaSeq 6000 platform at the UoC Centre for Health Genomics and Informatics) to provide in-depth coverage of the microbial metagenome. Sequences will be analyzed for species level abundances, beta diversity metrics, and functional capacity based on gene content.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start1 Mar 2022 (estimated)
- Primary completion20 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Crohn's and Colitis Foundation
- Responsible party
- Principal investigator, Maitreyi Raman, University of Calgary
- Investigators
- Maitreyi Raman, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230160
- Sponsor's protocol ID
- REB21-1539
- Acronym
- CD-Fast
- Status last verified
- Jan 2022
- First submitted
- 27 Jan 2022
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No There is no plan to make individual participant data available to other researchers outside of the study team.
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Intermittent Fasting Induce Weight Loss and Improve Gut Health as Compared to Standard Medical Care in Patients With Obesity/High BMI and Crohn's Disease.
- ClinicalTrials.gov ID
- NCT05230160
- Acronym / sponsor ID
- CD-Fast / REB21-1539
- Conditions
- Crohn Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Crohn's and Colitis Foundation
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 8 Feb 2022 (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.
Diet is a determinant of gut microbial diversity and composition and is recognized as a potential environmental trigger for IBD; for example, high-fat diets are associated with increased risk of CD in pre-clinical models, with effects mediated through dysbiosis and altered gut permeability.
Diet is also a potential non-pharmacological therapy for weight loss and for reducing the occurrence of disease flares and the reliance on dose escalation of biologic agents. Indeed, there is accumulating evidence for the role of diet in the treatment of CD, and diet-induced improvement of microbial dysbiosis is associated with induction of remission in pediatric patients with active CD.
Intermittent Fasting (IF) is a dietary intervention that involves periodic intervals of no or very limited energy intake. We want to determine the efficacy and feasibility of a 12-week IF(Intermittent Fasting) intervention to induce weight loss (by 1 BMI unit reduction), decrease biomarker inflammation and increase microbial functional diversity compared to standard medical management (SM) in a pilot study of individuals with overweight or obesity and CD in clinical remission with elevated biomarkers of inflammation, indicated by fecal calprotectin (FCP) > 250 µg/g or C-reactive protein (CRP) > 5 mg/L).
Detailed description
Objectives: To determine if a 12-week IF intervention compared to SM:
- Induces weight loss of at least 1 BMI unit.
- Reduces intestinal and systemic inflammation.
- Alters gut microbial community structure (beta-diversity) from baseline.
- Alters the adipokines and myokines leptin, adiponectin, IL-6, or irisin.
- Alters zonulin and serum levels of gastrointestinal hormones ghrehlin, glucagon-like peptide 1 (GLP-1), and glucagon-like peptide 2 (GLP-2).
- Alters body composition and whether changes in body composition have an effect on biomarkers of inflammation.
- Is a feasible and sustainable intervention for patients with CD.
Hypotheses: We hypothesize that, compared to SM, IF will:
- Induce at least a 1-unit decrease in BMI over the course of the intervention.
- Improve inflammatory markers of CD, demonstrated by a decrease in FCP by ≥ 50%, normalization of FCP to ≤ 100 µg/g, or a decrease in CRP to ≤ 5 mg/L.
- Alter gut microbial community structure (beta-diversity ) and lead to enrichment of bacterial species typically depleted in CD, such as Faecalibacterium prausnitzii and Roseburia hominus with concomitant decreases in Escherichia coli and overall Proteobacteria phylum abundance.
- Alter adipokines and myokines (leptin, adiponectin, IL-6, and irisin), zonulin and serum levels of gastrointestinal hormones (ghrehlin, GLP-1, and GLP-2).
- Alter body composition by decreasing VAT.
- Be a feasible and sustainable treatment option for patients with CD
Methods
Study Design:
The study is a 12-week pilot randomized controlled trial (RCT). Eligible participants (N=42) will be randomized 1:1 to either the IF or the SM control group. Patients from the University of Calgary IBD clinic will be enrolled in the RCT.
Screening:
The study RD will assess participants for malnutrition using the abridged patient-generated subjective global assessment (PG-SGA), a validated tool to determine malnutrition status in patients with chronic disease. The Nine Item Avoidant/Restrictive Food Intake Disorder screen33 will be completed to rule out avoidant and restrictive food behaviours that may increase the malnutrition risk of an IF intervention.
Inclusion criteria:
- ≥ 18 to ≤ 75 years of age; 2) ileocolonic or colonic CD in clinical remission diagnosed through conventional definitions with a Harvey Bradshaw Index (HBI) < 5 within 3 months of recruitment; 3) presence of inflammation using an FCP ≥ 250 µg/g or a CRP ≥ 5 mg/L; 4) stable dosing of biologic agents and/or immunomodulators and/or oral or rectal 5-ASA, and no changes to medical management (including corticosteroid exposure) for at least 3 months prior to recruitment; and 5) presence of overweight or obesity with BMI > 25 and a PG-SGA of class A.
Exclusion criteria:
- upper gastrointestinal involvement CD, fistulizing disease; 2) documented strictures based on sonographic findings or colonoscopy within the last year; 3) > 1 small bowel resection; 4) colectomy; 5) presence of an ostomy; 6) antibiotic use in past 3-months; 7) pregnancy; and 8) corticosteroids in the last 3 months.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Intermittent FastingThe IF group will fast for 16 consecutive hours on 6 days per week with an 8-hour eating window (e.g., eat from 10 a.m. to 6 p.m.). The IF group will consume their habitual diet in terms of food choices and energy intake, but only during the 8-hour and full-day non-fasting periods. An RD will meet virtually with participants in the IF group at baseline to teach them the fasting protocol and how to manage energy intake and hunger, as well as to reinforce the requirement to not change habitual dietary practices. The research coordinator will call patients every two weeks to assess for changes in medications, compliance with the fasting protocol, and symptoms (assessed monthly) using the modified HBI. |
| Standard Medical Care Group | No intervention | –The control group will continue with their habitual dietary pattern. The research coordinator will call patients at baseline and every two weeks to assess for changes in medications and symptoms (assessed monthly) using the modified HBI. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 18 to ≤ 75 years of age;
- ileocolonic or colonic CD in clinical remission diagnosed through conventional definitions with a Harvey Bradshaw Index (HBI) < 5 within 3 months of recruitment;
- presence of inflammation using an FCP ≥ 250 µg/g or a CRP ≥ 5 mg/L;
- stable dosing of biologic agents and/or immunomodulators and/or oral or rectal 5-ASA, and no changes to medical management (including corticosteroid exposure) for at least 3 months prior to recruitment
- presence of overweight or obesity with BMI > 25 and a PG-SGA of class A.
Key exclusion criteria (8 listed)
- upper gastrointestinal involvement CD, fistulizing disease;
- documented strictures based on sonographic findings or colonoscopy within the last year;
- > 1 small bowel resection;
- colectomy;
- presence of an ostomy;
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 FastingIntermittent Fasting (IF) is a dietary intervention that involves periodic intervals of no or very limited energy intake. Fasting and feeding intervals vary and the practice of IF commonly consists of either a daily fast for 16 hours, a 24-hour fast on alternate days, or a fast two days per week on non-consecutive days. For the study, the IF group will be asked to fast for 16 consecutive hours, 6 days per week. This means they will have an 8-hour eating window (e.g., eat from 10 a.m. to 6 p.m.) each day. They will be asked to eat the same types of food and the same amounts as usual, but only during the 8-hour eating window. | Other | Intervention Group |
Primary outcome
BMI-A decrease in BMI of at least 1 BMI unit over the course of the intervention: Change is being assessed
Time frame: Baseline and Week 12
A measure of body fat based on height and weight
Fecal Calprotectin: Change is being assessed
Time frame: Baseline and Week 12
FCP is a test used to detect inflammation in the colon and is associated with disease
C Reactive Protien: Change is being assessed
Time frame: Baseline and Week 12
A protein the liver produces in the presence of inflammatory disease
5 secondary outcomes
24 hour ASA food recalls: Change is being assessed.
Time frame: Baseline and week 12
Serum and fecal metabolomics: Change is being assessed
Time frame: Baseline and Week 12
Serum markers: Change is being assessed
Time frame: Baseline and week 12
Body Composition: Change is being assessed
Time frame: Baseline and week 12
Fecal microbiome: Change is being assessed
Time frame: Baseline and Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Individual participant dataSharing planned: No. No There is no plan to make individual participant data available to other researchers outside of the study team.
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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.
Maitreyi Raman, MD principal investigator
University of Calgary
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 Fasting in people with Crohn Disease, run by University of Calgary at 1 site in Canada.
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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 8 Feb 2022. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maitreyi Raman, MD (403-592-5020, mkothand@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI-A decrease in BMI of at least 1 BMI unit over the course of the intervention: Change is being assessed (time frame: Baseline and Week 12). 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?
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 Feb 2022.