Ulcerative ColitisNCT04147598
Diet Study on Ulcerative Colitis
A study testing LFD and SAD in people with Ulcerative Colitis, run by University of Miami at 1 site in United States.
Trial summary
The primary purpose of this study is to determine the effectiveness of a low-fat or standard American diet (high in fat) in helping people with ulcerative colitis improve their symptoms and the signs of inflammation in blood tests and in bowel biopsies. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- LFD and SAD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2015to 11 Sep 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female ≥18 and ≤70 years old
- History of UC of at least 3 months duration
- UC should be confirmed by colonoscopy within two years of entry into the study
- Patients with mild to moderate UC, or patients in remission that have had active disease within the past 18 months, regardless of treatment with mesalamines, immunosuppressants, anti-TNFs and/or vedolizumab
- Patients on oral 5-aminosalicylates, mesalamine or sulfasalazine must be on a stable dose for ≥2 weeks prior to screening
- Patients treated with anti-TNFs or immunosuppressants (AZA, 6-MP, or methotrexate) at screening must have been on a stable dose for ≥8 weeks and remain on the same dose during the treatment period
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- Patients on steroids can be on no more than prednisone 20mg daily or budesonide 9mg daily at screening. If clinically indicated, tapering of steroids after 4 weeks of intervention may occur. Prednisone may be tapered by no more than 2.5mg/week and budesonide by no more than 3mg/week.
- Patients on infliximab, premedication may include intravenous corticosteroid
- No antibiotic use or probiotic use within 4 weeks prior to screening
- Signed written informed consent for enrollment into the study
Who cannot join
- Patients with Crohn's Disease and Celiac Disease
- History of colonic dysplasia except for adenoma on prior surveillance colonoscopy
- Patients with altered anatomy: prior colectomy or anticipated colectomy during the study period and presence of ileal pouch or ostomy
- Clinical manifestations concerning for fulminant disease or toxic megacolon
- Patients with stool sample positive at during screening period or at least <12 weeks for ova, parasites, or culture for aerobic pathogens including: Aeromonas, Plesiomonas, Shigella, Yersinia, Campylobacter and E.coli spp. or positive for Clostridium difficile B toxin in stools
- Use of cyclosporine, mycophenolate mofetil, sirolimus, thalidomide or tacrolimus within 2 months prior to screening
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- Need for prednisone >20mg daily or budesonide >9mg daily at the time of screening
- Received intravenous corticosteroids within 2 weeks prior to screening, during screening, or during the study period, except as premedication for anti-TNFs
- Use of Total Parenteral Nutrition at the time of screening and during the study period
- Anti-diarrheal use within 2 weeks prior to screening
- Presence of any of the following laboratory abnormalities during screening period or at least <12 weeks
- Hemoglobin <8.0g/dl
- Albumin <2.8g/dl
- Conditions/situations such as:
- Patients with short life expectancy
- Uncooperative behavior or any condition that could make the patient potentially non-compliant to the study procedures
- Patients with pacemaker
- Other significant or life-threatening co-morbidities in which diet intervention could negatively affect
- Failure to meet any of the inclusion criteria
- Poor compliance with diet during the study period
- Failure to submit stool samples as indicated at each phase of the study
- The need for antibiotic use during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dietary Control of Fat to Modify Colonic Inflammation in Ulcerative Colitis
The primary purpose of this study is to determine the effectiveness of a low-fat or standard American diet (high in fat) in helping people with ulcerative colitis improve their symptoms and the signs of inflammation in blood tests and in bowel biopsies.
- Conditions
- Ulcerative Colitis
- Being tested
- LFD, SAD
- Keywords
- Inflammatory bowel disease, diet, low fat, UC, IBD
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LFDOther
Participants will receive daily prepared food trays to achieve a diet with approximately 10% of total fat, 1-5% of calories from saturated fat, and 5-9% of MUFA and PUFA. This diet will contain an approximate ratio of 1:1 of omega-6/omega-3 fatty acids.
SADOther
Participants will receive daily prepared food trays to achieve a diet with approximately 35-40% of calories from fat, 10-11% of saturated fats, and 25-29% would be mono-unsaturated (MUFA) and PUFA. This diet will contain a 20-30:1 ratio of omega-6/omega-3 fatty acids, representing the current SAD.
| Study group | Role | What they receive |
|---|---|---|
| Low Fat Diet (LFD) to Standard American Diet (SAD) | Experimental | Week 1 to 4 participants will receive a LFD followed by a washout period of 2 weeks and then week 6 to 10 SAD. Receives: Other: LFD; Other: SAD |
| SAD to LFD | Experimental | Week 1 to 4 participants will receive a SAD followed by a washout period of 2 weeks and then week 6 to 10 LFD. Receives: Other: LFD; Other: SAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life as measured by the Short Inflammatory Bowel Disease Questionnaire (sIBDQ).
sIBDQ is a 10-item shortened version of the original IBDQ assessing quality of life (QOL) with total scores ranging from 1 to 7 with a higher score indicating a better QOL.
Measured: Baseline, 4 weeks
Change in quality of life as measured by the Food-Related Quality of Life (FR-QoL-29) Questionnaire.
FR-QoL-29 is a 29-item questionnaire assessing quality of life (QOL) with total scores ranging from 29 to 145 with a score less than 90 suggesting poor food related QoL.
Measured: Baseline, 4 weeks
Change in quality of life as measured by the Medical Outcomes Short Form-36 (SF-36) Questionnaire.
SF-36 is a 36-item questionnaire assessing quality of life (QOL) with total scores ranging from 0 to 100 with a higher score indicating a better QOL.
Measured: Baseline, 4 weeks
Change in the expression of inflammatory markers in the colon.
Change in the expression of interleukin (IL)-1β, IL-6 and Tumor Necrosis Factor alpha (TNFa) evaluated in pg/mL.
Measured: Baseline, 4 weeks
Change in the expression of cytokine in the colon.
Change in the expression of cytokine high-sensitivity C-reactive protein (hsCRP) evaluted in mg/L.
Measured: Baseline, 4 weeks
Change in intestinal microbiota
Change in relative abundance of the microbial communities evaluated as a percentage.
Measured: Baseline, 4 weeks
Secondary outcomes (4)
Change in Ulcerative Colitis (UC) symptoms as measured by the partial Mayo score
The partial Mayo score ranges from 0 to 9 with a higher score indicating worsening UC symptoms.
Measured: Baseline, 4 weeks
Change in UC symptoms as measured by the Simple Clinical Colitis Activity Index (SCCAI)
SCCAI score ranges from 0 to 19 with a higher score indicating worsening UC symptoms.
Measured: Baseline, 4 weeks
Rate of adherence to fat intake
Adherence to fat intake is measured by the web-based daily food diary software Nutrihand.
Measured: Baseline, 4 weeks
Rate of adherence to diet items
Adherence to diet items is measured by the web-based daily food diary software Nutrihand.
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start25 Feb 2015
- Primary completion11 Sep 2018
- Study completion11 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 MiamiThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Broad Medical Research Program Crohn's and Colitis Foundation
- Responsible party
- Principal investigator, Maria Abreu, University of Miami
- Investigators
- Maria Abreu, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147598
- Sponsor's protocol ID
- 20130716
- Status last verified
- Oct 2019
- First submitted
- 30 Oct 2019
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fritsch J, Garces L, Quintero MA, Pignac-Kobinger J, Santander AM, Fernandez I, Ban YJ, Kwon D, Phillips MC, Knight K, Mao Q, Santaolalla R, Chen XS, Maruthamuthu M, Solis N, Damas OM, Kerman DH, Deshpande AR, Lewis JE, Chen C, Abreu MT. Low-Fat, High-Fiber Diet Reduces Markers of Inflammation and Dysbiosis and Improves Quality of Life in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1189-1199.e30. doi: 10.1016/j.cgh.2020.05.026. Epub 2020 May 20.
PubMed 32445952
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Control of Fat to Modify Colonic Inflammation in Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT04147598
- Acronym / sponsor ID
- 20130716
- Conditions
- Ulcerative Colitis
- Keywords
- Inflammatory bowel disease, diet, low fat, UC, IBD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Broad Medical Research Program Crohn's and Colitis Foundation
- Study start
- 25 Feb 2015 (actual)
- Primary completion
- 11 Sep 2018 (actual)
- Study completion
- 11 Sep 2018 (actual)
- First posted
- 1 Nov 2019 (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.
The primary purpose of this study is to determine the effectiveness of a low-fat or standard American diet (high in fat) in helping people with ulcerative colitis improve their symptoms and the signs of inflammation in blood tests and in bowel biopsies.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Fat Diet (LFD) to Standard American Diet (SAD) | Experimental | Other: LFD, Other: SADWeek 1 to 4 participants will receive a LFD followed by a washout period of 2 weeks and then week 6 to 10 SAD. |
| SAD to LFD | Experimental | Other: LFD, Other: SADWeek 1 to 4 participants will receive a SAD followed by a washout period of 2 weeks and then week 6 to 10 LFD. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or Female ≥18 and ≤70 years old
- History of UC of at least 3 months duration
- UC should be confirmed by colonoscopy within two years of entry into the study
- Patients with mild to moderate UC, or patients in remission that have had active disease within the past 18 months, regardless of treatment with mesalamines, immunosuppressants, anti-TNFs and/or vedolizumab
- No antibiotic use or probiotic use within 4 weeks prior to screening
Key exclusion criteria (22 listed)
- Patients with Crohn's Disease and Celiac Disease
- History of colonic dysplasia except for adenoma on prior surveillance colonoscopy
- Patients with altered anatomy: prior colectomy or anticipated colectomy during the study period and presence of ileal pouch or ostomy
- Clinical manifestations concerning for fulminant disease or toxic megacolon
- Patients with stool sample positive at during screening period or at least <12 weeks for ova, parasites, or culture for aerobic pathogens including: Aeromonas, Plesiomonas, Shigella, Yersinia, Campylobacter and E.coli spp. or positive for Clostridium difficile B toxin in stools
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 |
|---|---|---|
| LFDParticipants will receive daily prepared food trays to achieve a diet with approximately 10% of total fat, 1-5% of calories from saturated fat, and 5-9% of MUFA and PUFA. This diet will contain an approximate ratio of 1:1 of omega-6/omega-3 fatty acids. | Other | Low Fat Diet (LFD) to Standard American Diet (SAD), SAD to LFD |
| SADParticipants will receive daily prepared food trays to achieve a diet with approximately 35-40% of calories from fat, 10-11% of saturated fats, and 25-29% would be mono-unsaturated (MUFA) and PUFA. This diet will contain a 20-30:1 ratio of omega-6/omega-3 fatty acids, representing the current SAD. | Other | Low Fat Diet (LFD) to Standard American Diet (SAD), SAD to LFD |
Primary outcome
Change in quality of life as measured by the Short Inflammatory Bowel Disease Questionnaire (sIBDQ).
Time frame: Baseline, 4 weeks
sIBDQ is a 10-item shortened version of the original IBDQ assessing quality of life (QOL) with total scores ranging from 1 to 7 with a higher score indicating a better QOL.
Change in quality of life as measured by the Food-Related Quality of Life (FR-QoL-29) Questionnaire.
Time frame: Baseline, 4 weeks
FR-QoL-29 is a 29-item questionnaire assessing quality of life (QOL) with total scores ranging from 29 to 145 with a score less than 90 suggesting poor food related QoL.
Change in quality of life as measured by the Medical Outcomes Short Form-36 (SF-36) Questionnaire.
Time frame: Baseline, 4 weeks
SF-36 is a 36-item questionnaire assessing quality of life (QOL) with total scores ranging from 0 to 100 with a higher score indicating a better QOL.
Change in the expression of inflammatory markers in the colon.
Time frame: Baseline, 4 weeks
Change in the expression of interleukin (IL)-1β, IL-6 and Tumor Necrosis Factor alpha (TNFa) evaluated in pg/mL.
Change in the expression of cytokine in the colon.
Time frame: Baseline, 4 weeks
Change in the expression of cytokine high-sensitivity C-reactive protein (hsCRP) evaluted in mg/L.
Change in intestinal microbiota
Time frame: Baseline, 4 weeks
Change in relative abundance of the microbial communities evaluated as a percentage.
4 secondary outcomes
Change in Ulcerative Colitis (UC) symptoms as measured by the partial Mayo score
Time frame: Baseline, 4 weeks
Change in UC symptoms as measured by the Simple Clinical Colitis Activity Index (SCCAI)
Time frame: Baseline, 4 weeks
Rate of adherence to fat intake
Time frame: Baseline, 4 weeks
Rate of adherence to diet items
Time frame: Baseline, 4 weeks
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 1 Nov 2019.
- Derived from this study: PubMed 32445952Fritsch J, Garces L, Quintero MA, Pignac-Kobinger J, Santander AM, Fernandez I, Ban YJ, Kwon D, Phillips MC, Knight K, Mao Q, Santaolalla R, Chen XS, Maruthamuthu M, Solis N, Damas OM, Kerman DH, Deshpande AR, Lewis JE, Chen C, Abreu MT. Low-Fat, High-Fiber Diet Reduces Markers of Inflammation and Dysbiosis and Improves Quality of Life in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1189-1199.e30. doi: 10.1016/j.cgh.2020.05.026. Epub 2020 May 20.
- 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.
Maria Abreu, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LFD and SAD in people with Ulcerative Colitis, run by University of Miami 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 10 inclusion and 22 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 1 Nov 2019. 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 quality of life as measured by the Short Inflammatory Bowel Disease Questionnaire (sIBDQ). (time frame: Baseline, 4 weeks). The study lists 6 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 NCT04147598, which also lists 1 linked publication.
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 1 Nov 2019.