Ulcerative ColitisNCT02093780
Personalized "Alberta" Diet for Prevention of Relapse in Ulcerative Colitis
A study testing Alberta Anti-inflammatory diet and Canada's Food Guide Diet in people with Ulcerative Colitis, run by University of Alberta at 1 site in Canada.
Trial summary
In the present study, ulcerative colitis (UC) patients in the remission stage of the disease will be randomized into two groups: Alberta anti-inflammatory diet and Canada's Food Guide diet. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Alberta Anti-inflammatory diet and Canada's Food Guide Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2014to Oct 2017
- 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
- Participants must have Ulcerative Colitis in clinical remission (partial Mayo score of less than 2)
- Fecal calprotectin of more than 150 microgram/g
- Patients on oral 5-ASA drugs and/or Azathioprine or 6-mercaptopurine as long as the dose has been stable for 2 weeks (between 2-2.4 gram daily for oral 5-ASA) or 2 months (for azathioprine or 6-mercaptopurine).
- Participants must be generally healthy besides having UC
- Must be able to communicate in English.
- Live in the Edmonton Area.
Who cannot join
- Use of prednisone (or steroid equivalent) at the time of enrollment.
- Use of anti-TNF drugs within 3 months of enrollment.
- Use of antibiotics (washout period of at least 2 weeks is required).
- Pregnancy or lactation.
- History of colectomy.
- Significant chronic disorders such as severe cardiac disease, significant renal failure, severe pulmonary disease (need for oxygen).
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- Active gastrointestinal infection.
- Severe psychiatric disorder.
- Unable or unwilling to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Dietary Approach to Reduce the Frequency of Relapse in Ulcerative Colitis Patients: a Randomized Controlled Clinical Trial Study
In the present study, ulcerative colitis (UC) patients in the remission stage of the disease will be randomized into two groups: Alberta anti-inflammatory diet and Canada's Food Guide diet. The elements of Alberta anti-inflammatory diet have previously been shown to have a role in decreasing the risk of UC development or management of UC-related symptoms or relapse. Since the primary outcome of interest is the relapse rate in two groups, disease status will be assessed monthly using appropriate tools. In order to find out the underlying mechanisms that will relate the proposed diet to decreased flare rate, some laboratory evaluations, which are mainly markers of inflammation or are related to gut microbiome will be conducted. In the present study, the investigators will also perform state-of-the art metabolomics tests, in order to study how the dietary changes will change the end metabolites. In addition, the investigators will be able to explore if metabolomic profile of participants can predict future UC relapse. This study will last for 6 months from baseline wherein all the study subjects will receive appropriate dietary instructions in addition to their stable doses of maintenance drug therapy.
Read the detailed description
Recent research suggests that habitual dietary may play an important part in the treatment of inflammatory bowel disease (IBD), but this has not been systematically explored. Habitual intake of a diet that is rich in "anti-inflammatory" nutrients (e.g. n-3 fatty acids, polyphenols), soluble fiber and other prebiotics (e.g. inulin), and probiotics (that improve gut microbiota) may lead to major improvements in IBD disease. Ultimately, the investigators are interested in studying the extent to which habitually eating foods, sources of these important nutrients and dietary components, might help people with IBD living in Alberta. Thus, the information about nutrients and dietary components must be translated to foods and dietary patterns that are acceptable and accessible to people in Alberta. This study will compare the effectiveness of 2 different approaches, either a structured, personalized menu plan constructed with a dietitian (intervention group) vs. general advice to follow Canada's Food Guide by a dietitian (control group), to promoting uptake and adherence to an appropriate diet. The control group will receive the same care as the intervention group as far as access to a registered dietitian. In the intervention group, the nutritional advice offered will be to follow a structured four-week menu plan that includes recipes and nutrition tips. The menu plan emphasizes specific foods that have been shown in the literature to improve IBD symptoms. In the control group, the nutritional advice will be general and will emphasize the principles outlined in Canada's Food Guide. Each control participant will be provided with their daily serving size allowance for each of the four food groups. Each participant will have sole responsibility in deciding which foods are selected from each food group; specific foods will not be highlighted.
Objectives: To evaluate if the proposed Alberta anti-inflammatory diet is effective for the prevention of relapses in ulcerative colitis as well as to determine their protective mechanisms
Study Design: Randomized controlled clinical trial Study Population and Number of Subjects: 70 patients with ulcerative colitis in clinical remission Duration of Treatment: 6 months Primary Endpoint: Patient relapse rate over 6 months Secondary Endpoints: Changes in: 1) Time to relapse; 2) Patients' quality of life during the study period; 3) Mucosal inflammation, measured by fecal calprotectin at baseline, months 1, 3, 6 or at relapse; 4) Partial Mayo score at the baseline and monthly, or at a relapse; 5) Laboratory markers of inflammation
Subject visits:
- Screening Visit
- Assessment of inclusion of exclusion criteria
- Obtainment of Informed Consent
- Medical History
- Pregnancy Test
- Partial Mayo score
- Visit Month 0 (baseline), 1, 3, 6 (or at relapse)
- Focused Physical Exam and Medical History
- Partial Mayo score
- Fecal samples for Calprotectin and luminal microflora analysis
- Blood and urine samples for metabolomic analysis, inflammatory markers and other tests specified in the appendix 2.
- Dietary counseling
- Questionnaires specified in the appendix 2.
- Sigmoidoscopy (only at relapse)
- Visit at Month 2, 4, 5
- Telephone interview by the dietician
- Partial mayo score
- Questionnaires specified in the appendix 2
Studies to Evaluate Mechanisms of Action of the Alberta anti-inflammatory diet:
- Compositional changes of the intestinal microbiota in fecal samples, using pyrosequencing
- Host and microbial metabolomics in serum and urine samples using gas chromatography and nuclear magnetic resonance
- Evaluations of inflammatory markers (fecal calprotectin, serum interleukin (IL) -6, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and lipopolysaccharide (LPS).
- Conditions
- Ulcerative Colitis
- Being tested
- Alberta Anti-inflammatory diet, Canada's Food Guide Diet
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alberta Anti-inflammatory dietBehavioural
Patients randomized to Alberta Anti-inflammatory diet will follow a strict menu plan designed by certified dietitian for 6 months.
Canada's Food Guide DietBehavioural
Patients randomized to Canada's Food Guide diet will receive counseling by certified dietitian for 6 months and will design their own diet following Canada's Food Guide.
| Study group | Role | What they receive |
|---|---|---|
| Alberta Anti-inflammatory Diet | Experimental | Patients randomized into this group will receive a dietary menu plan that contains anti-inflammatory foods/nutrients that have been shown to be effective in the management of IBD in previous studies. The main aim of this diet will be to increase dietary intakes of prebiotics/probiotics, omega 3 fatty acids, fiber (soluble), antioxidants and decrease dietary intake of red and processed meat. Receives: Behavioral: Alberta Anti-inflammatory diet |
| Canada's Food Guide Diet | Active comparator | Patients that have been randomized into this group will receive simple dietary recommendations based on the Canada's Food Guide. The details of Canada's Food Guide can be available here:
http://www.hc-sc.gc.ca/fn-an/food-guide-aliment/index-eng.php Receives: Behavioral: Canada's Food Guide Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient relapse rate
Relapse is defined as the total partial Mayo score exceeds 2. Partial Mayo score represents a sum of the subject's symptoms for rectal bleeding and stool frequency, as well as a physician global assessment score, each of them scored from 0 to 3.
Measured: 6 months
Secondary outcomes (4)
Time to relapse
Time from start until clinical relapse (outcome 1)
Measured: 6 months
Quality of Life improvement
Improvement of Quality of Life
Measured: 6 months
change in mucosal inflammation, measured by fecal calprotectin
Mucosal inflammation, measured by fecal calprotectin at baseline, months 1, 3, 6 or at relapse
Measured: 6 months
changes in partial Mayo score from baseline
Partial Mayo disease activity score at the baseline and monthly, and at a relapse
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2017
- Study completionOct 2017
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 Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Levinus Dieleman, University of Alberta
- Investigators
- Levinus A Dieleman, MD, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093780
- Sponsor's protocol ID
- Pro00035413
- Status last verified
- Apr 2018
- First submitted
- 19 Mar 2014
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Olendzki BC, Silverstein TD, Persuitte GM, Ma Y, Baldwin KR, Cave D. An anti-inflammatory diet as treatment for inflammatory bowel disease: a case series report. Nutr J. 2014 Jan 16;13:5. doi: 10.1186/1475-2891-13-5.
PubMed 24428901Richman E, Rhodes JM. Review article: evidence-based dietary advice for patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2013 Nov;38(10):1156-71. doi: 10.1111/apt.12500. Epub 2013 Sep 17.
PubMed 24102340
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dietary Approach to Reduce the Frequency of Relapse in Ulcerative Colitis Patients: a Randomized Controlled Clinical Trial Study
- ClinicalTrials.gov ID
- NCT02093780
- Acronym / sponsor ID
- Pro00035413
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 21 Mar 2014 (estimated)
- 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.
In the present study, ulcerative colitis (UC) patients in the remission stage of the disease will be randomized into two groups: Alberta anti-inflammatory diet and Canada's Food Guide diet. The elements of Alberta anti-inflammatory diet have previously been shown to have a role in decreasing the risk of UC development or management of UC-related symptoms or relapse. Since the primary outcome of interest is the relapse rate in two groups, disease status will be assessed monthly using appropriate tools. In order to find out the underlying mechanisms that will relate the proposed diet to decreased flare rate, some laboratory evaluations, which are mainly markers of inflammation or are related to gut microbiome will be conducted. In the present study, the investigators will also perform state-of-the art metabolomics tests, in order to study how the dietary changes will change the end metabolites. In addition, the investigators will be able to explore if metabolomic profile of participants can predict future UC relapse. This study will last for 6 months from baseline wherein all the study subjects will receive appropriate dietary instructions in addition to their stable doses of maintenance drug therapy.
Detailed description
Recent research suggests that habitual dietary may play an important part in the treatment of inflammatory bowel disease (IBD), but this has not been systematically explored. Habitual intake of a diet that is rich in "anti-inflammatory" nutrients (e.g. n-3 fatty acids, polyphenols), soluble fiber and other prebiotics (e.g. inulin), and probiotics (that improve gut microbiota) may lead to major improvements in IBD disease. Ultimately, the investigators are interested in studying the extent to which habitually eating foods, sources of these important nutrients and dietary components, might help people with IBD living in Alberta. Thus, the information about nutrients and dietary components must be translated to foods and dietary patterns that are acceptable and accessible to people in Alberta. This study will compare the effectiveness of 2 different approaches, either a structured, personalized menu plan constructed with a dietitian (intervention group) vs. general advice to follow Canada's Food Guide by a dietitian (control group), to promoting uptake and adherence to an appropriate diet. The control group will receive the same care as the intervention group as far as access to a registered dietitian. In the intervention group, the nutritional advice offered will be to follow a structured four-week menu plan that includes recipes and nutrition tips. The menu plan emphasizes specific foods that have been shown in the literature to improve IBD symptoms. In the control group, the nutritional advice will be general and will emphasize the principles outlined in Canada's Food Guide. Each control participant will be provided with their daily serving size allowance for each of the four food groups. Each participant will have sole responsibility in deciding which foods are selected from each food group; specific foods will not be highlighted.
Objectives: To evaluate if the proposed Alberta anti-inflammatory diet is effective for the prevention of relapses in ulcerative colitis as well as to determine their protective mechanisms
Study Design: Randomized controlled clinical trial Study Population and Number of Subjects: 70 patients with ulcerative colitis in clinical remission Duration of Treatment: 6 months Primary Endpoint: Patient relapse rate over 6 months Secondary Endpoints: Changes in: 1) Time to relapse; 2) Patients' quality of life during the study period; 3) Mucosal inflammation, measured by fecal calprotectin at baseline, months 1, 3, 6 or at relapse; 4) Partial Mayo score at the baseline and monthly, or at a relapse; 5) Laboratory markers of inflammation
Subject visits:
- Screening Visit
- Assessment of inclusion of exclusion criteria
- Obtainment of Informed Consent
- Medical History
- Pregnancy Test
- Partial Mayo score
- Visit Month 0 (baseline), 1, 3, 6 (or at relapse)
- Focused Physical Exam and Medical History
- Partial Mayo score
- Fecal samples for Calprotectin and luminal microflora analysis
- Blood and urine samples for metabolomic analysis, inflammatory markers and other tests specified in the appendix 2.
- Dietary counseling
- Questionnaires specified in the appendix 2.
- Sigmoidoscopy (only at relapse)
- Visit at Month 2, 4, 5
- Telephone interview by the dietician
- Partial mayo score
- Questionnaires specified in the appendix 2
Studies to Evaluate Mechanisms of Action of the Alberta anti-inflammatory diet:
- Compositional changes of the intestinal microbiota in fecal samples, using pyrosequencing
- Host and microbial metabolomics in serum and urine samples using gas chromatography and nuclear magnetic resonance
- Evaluations of inflammatory markers (fecal calprotectin, serum interleukin (IL) -6, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and lipopolysaccharide (LPS).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alberta Anti-inflammatory Diet | Experimental | Behavioral: Alberta Anti-inflammatory dietPatients randomized into this group will receive a dietary menu plan that contains anti-inflammatory foods/nutrients that have been shown to be effective in the management of IBD in previous studies. The main aim of this diet will be to increase dietary intakes of prebiotics/probiotics, omega 3 fatty acids, fiber (soluble), antioxidants and decrease dietary intake of red and processed meat. |
| Canada's Food Guide Diet | Active comparator | Behavioral: Canada's Food Guide DietPatients that have been randomized into this group will receive simple dietary recommendations based on the Canada's Food Guide. The details of Canada's Food Guide can be available here: http://www.hc-sc.gc.ca/fn-an/food-guide-aliment/index-eng.php |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants must have Ulcerative Colitis in clinical remission (partial Mayo score of less than 2)
- Fecal calprotectin of more than 150 microgram/g
- Patients on oral 5-ASA drugs and/or Azathioprine or 6-mercaptopurine as long as the dose has been stable for 2 weeks (between 2-2.4 gram daily for oral 5-ASA) or 2 months (for azathioprine or 6-mercaptopurine).
- Participants must be generally healthy besides having UC
- Must be able to communicate in English.
Key exclusion criteria (9 listed)
- Use of prednisone (or steroid equivalent) at the time of enrollment.
- Use of anti-TNF drugs within 3 months of enrollment.
- Use of antibiotics (washout period of at least 2 weeks is required).
- Pregnancy or lactation.
- History of colectomy.
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 |
|---|---|---|
| Alberta Anti-inflammatory dietPatients randomized to Alberta Anti-inflammatory diet will follow a strict menu plan designed by certified dietitian for 6 months. | Behavioural | Alberta Anti-inflammatory Diet |
| Canada's Food Guide DietPatients randomized to Canada's Food Guide diet will receive counseling by certified dietitian for 6 months and will design their own diet following Canada's Food Guide. | Behavioural | Canada's Food Guide Diet |
Primary outcome
Patient relapse rate
Time frame: 6 months
Relapse is defined as the total partial Mayo score exceeds 2. Partial Mayo score represents a sum of the subject's symptoms for rectal bleeding and stool frequency, as well as a physician global assessment score, each of them scored from 0 to 3.
4 secondary outcomes
Time to relapse
Time frame: 6 months
Quality of Life improvement
Time frame: 6 months
change in mucosal inflammation, measured by fecal calprotectin
Time frame: 6 months
changes in partial Mayo score from baseline
Time frame: 6 months
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 2 May 2018.
- Background: PubMed 24428901Olendzki BC, Silverstein TD, Persuitte GM, Ma Y, Baldwin KR, Cave D. An anti-inflammatory diet as treatment for inflammatory bowel disease: a case series report. Nutr J. 2014 Jan 16;13:5. doi: 10.1186/1475-2891-13-5.
- Background: PubMed 24102340Richman E, Rhodes JM. Review article: evidence-based dietary advice for patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2013 Nov;38(10):1156-71. doi: 10.1111/apt.12500. Epub 2013 Sep 17.
- 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.
Levinus A Dieleman, MD, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alberta Anti-inflammatory diet and Canada's Food Guide Diet in people with Ulcerative Colitis, run by University of Alberta 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 6 inclusion and 9 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 2 May 2018. 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?
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?
Patient relapse rate (time frame: 6 months). 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 NCT02093780, 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 2 May 2018; AzTrials last refreshed its copy on 6 Nov 2026.