Crohn DiseaseNCT04213729
Diet Intervention for Crohn's Disease Patient
A study testing Diet Counseling, CD LFD and Dyadic Psychological Support (DPS) in people with Crohn Disease, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to determine the effectiveness of a low-fat, high fiber diet (LFD) containing a minimal proportion of fat to improve gastrointestinal symptoms, quality of life and signs of inflammation in blood and stool. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Diet Counseling, CD LFD and Dyadic Psychological Support (DPS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2019to 20 Feb 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female ≥18 and ≤70 years old and lives with someone that is involved in daily diet
- Documented diagnosed of Crohn's Disease
- sCDAI less than 400
- Patients on oral 5-aminosalicylates, mesalamine or sulfasalazine must be on a stable dose for ≥2 weeks prior to screening
- Treated with anti-Tumor Necrotic Factors (TNFs) or immunosuppressants (AZA, 6-Mercaptopurine (6-MP), or methotrexate) at screening must have been on a stable dose for ≥4 weeks
- On steroids can be on no more than prednisone 20 mg daily or budesonide 9 mg daily at the screening. If clinically indicated, tapering of steroids after 4 weeks of intervention may occur. Prednisone may be tapered by no more than 2.5mg/wk and budesonide by no more than 3 mg/wk.
Show all 10Show fewer
- No antibiotic use or probiotic use within 2 weeks prior to screening
- Male or Female ≥18 and ≤70 years old
- Live in the same household and be involved in the patients' daily diet
- No antibiotic use or probiotic use within 2 weeks prior to screening
Who cannot join
- Patients with Ulcerative Colitis and Celiac Disease
- Abdominal abscess, symptomatic Intestinal stricture, patients with altered anatomy: prior total colectomy or proctocolectomy or anticipated colectomy during the study period and presence of ileal pouch or ostomy
- Other clinically meaningful laboratory abnormalities: pregnancy or lactation, an unstable or uncontrolled medical disorder, colonic dysplasia or adenomas, and malignant neoplasms. Toxic megacolon situations such as Patients with short life expectancy
- Use of cyclosporine, mycophenolate mofetil, sirolimus, thalidomide or tacrolimus within 2 months prior to screening
- Need for prednisone > 20 mg daily or budesonide > 9 mg 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.
Show all 21Show fewer
- Presence of any of the following laboratory abnormalities during screening period or at least <12 weeks; Hemoglobin <8.0g/dl, Albumin <2.8g/dl.
- Uncooperative behavior or any condition that could make the patient potentially noncompliant to the study procedure
- Other significant or life-threatening co-morbidities in which low fat/high fiber diet intervention could negatively affect
- The need for antibiotic use during the study period
- Known allergy to tree nuts or peanuts
- Pregnant women
- Patients with Ulcerative Colitis and Celiac Disease
- Abdominal abscess, symptomatic Intestinal stricture, patients with altered anatomy: prior total colectomy or proctocolectomy or anticipated colectomy during the study period and presence of ileal pouch or ostomy
- Other clinically meaningful laboratory abnormalities: pregnancy or lactation, an unstable or uncontrolled medical disorder, colonic dysplasia or adenomas, and malignant neoplasms. Toxic megacolon situations such Uncooperative behavior or any condition that could make the patient potentially noncompliant to the study procedures. Patients with short life expectancy
- Use of cyclosporine, mycophenolate mofetil, sirolimus, thalidomide or tacrolimus within 2 months prior to screening
- Use of Total Parenteral Nutrition at the time of screening and during the study period.
- Other significant or life-threatening co-morbidities in which low fat/high fiber diet intervention could negatively affect
- The need for antibiotic use during the study period
- Known allergy to tree nuts or peanuts
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Holistic Diet Intervention for People With Crohn's Disease
The purpose of this study is to determine the effectiveness of a low-fat, high fiber diet (LFD) containing a minimal proportion of fat to improve gastrointestinal symptoms, quality of life and signs of inflammation in blood and stool.
- Conditions
- Crohn Disease
- Being tested
- Diet Counseling, CD LFD, Dyadic Psychological Support (DPS)
- Keywords
- Inflammatory bowel disease (IBD), Diet, CD, IBD, Psychological support, Family member, Low fat, high fiber, Dyadic
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet CounselingBehavioural
Standard of care diet counseling provided at clinic visit 1.
CD LFDOther
Daily breakfast, lunch, dinner and snacks LFD catered meals. Meals will have approximately 20% calories from fat, a goal ratio close to 1:1 omega-6/omega-3 fatty acids, and approximately 25-35 grams of fiber per day.
Dyadic Psychological Support (DPS)Behavioural
The dyadic psychosocial support (DPS) intervention will be provided for a total of 12 weeks. The 12-week DPS intervention consists of eight sessions (main sessions) and two booster sessions. The intervention will incorporate psychoeducational components that combine didactic and behavioral regulatory procedures to promote healthy diet behavior for self-determined reasons.
| Study group | Role | What they receive |
|---|---|---|
| Crohn's Disease (CD) Control Group | Active comparator | Participants will receive only the one time standard of care in-clinic diet counseling at visit 1. Receives: Behavioral: Diet Counseling |
| Experimental CD Low Fat Diet (LFD) Group | Experimental | Participants will be provided catered LFD meals for 8 consecutive weeks consisting of daily breakfast, lunch, dinner and snacks. Receives: Other: CD LFD |
| Experimental CD LFD + DPS Group | Experimental | Participants and one family member that lives with them will be provided catered LFD meals for 8 consecutive weeks consisting of daily breakfast, lunch, dinner and snacks. In addition, the participant and their family member will receive 12 consecutive weeks of Dyadic Psychological Support (DPS). Receives: Other: CD LFD; Behavioral: Dyadic Psychological Support (DPS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fat intake
Change in daily fat intake calculated through patient reported diet diary app Nutrihand.
Measured: Baseline, 8 weeks
Rate of adherence to fat intake
Adherence to fat intake is measured by the web-based Automated Self-Administered 24-hour diet recall (ASA24).
Measured: Week 36
Secondary outcomes (7)
Change in clinical symptoms as assessed by Patient Reported Outcomes (PRO2).
PRO2 is the sum of the average daily stool frequency and abdominal pain. A weighted total PRO2 score of less than 75 is an indication of remission.
Measured: Baseline, Week 8
Change in clinical symptoms as assessed by the Harvey Bradshaw Index (HBI)
HBI is a 5-item questionnaire. An HBI score of <5 indicates remission, 5-7 indicates mild disease, 8-16 indicates moderate disease and >16 indicates severe disease.
Measured: Baseline, Week 8
Change in clinical symptoms as assessed by the Short Crohn's Disease Activity Index (sCDAI).
sCDAI is the sum of the average daily stool frequency, general well-being and abdominal pain. A weighted total sCDAI score of less than 150 indicates remission, 150-219 indicates mild activity, 220-450 indicates moderate activity and > 450 indicates severe activity.
Measured: Baseline, Week 8
Change in quality of life (QoL) as assessed by the Short Inflammation Bowel Disease Questionnaire (sIBDQ).
sIBDQ is a 10-item shortened version of the original IBDQ assessing QOL with total scores ranging from 1 to 7 with a higher score indicating a better QOL.
Measured: Baseline, Week 8
Change in quality of life (QoL) as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29).
The PROMIS-29, a generic health-related quality of life survey, assesses each of the 7 PROMIS domains with 4 questions. The questions are ranked on a 5-point Likert Scale. There is also one 11-point rating scale for pain intensity. A score of 50 represents the mean or average of the reference population. A score of 60 means that the person is one standard deviation above the reference population (standard deviation = 10).
Measured: Baseline, Week 8
Change in the expression of cytokine high-sensitivity C-reactive protein (hsCRP).
Change in the expression of cytokine high-sensitivity C-reactive protein (hsCRP) evaluated in mg/L.
Measured: Baseline, Week 8
Change in the expression of Serum Amyloid A (SAA).
Change in the expression of SAA evaluated in pg/mL.
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start26 Nov 2019
- Primary completion20 Feb 2024
- Study completion20 Feb 2024
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 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust
- Responsible party
- Principal investigator, Maria Abreu, University of Miami
- Investigators
- Maria T Abreu, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213729
- Sponsor's protocol ID
- 20190548
- Status last verified
- Feb 2024
- First submitted
- 24 Dec 2019
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Holistic Diet Intervention for People With Crohn's Disease
- ClinicalTrials.gov ID
- NCT04213729
- Acronym / sponsor ID
- 20190548
- Conditions
- Crohn Disease
- Keywords
- Inflammatory bowel disease (IBD), Diet, CD, IBD, Psychological support, Family member, Low fat, high fiber, Dyadic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 30 Dec 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 purpose of this study is to determine the effectiveness of a low-fat, high fiber diet (LFD) containing a minimal proportion of fat to improve gastrointestinal symptoms, quality of life and signs of inflammation in blood and stool.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Crohn's Disease (CD) Control Group | Active comparator | Behavioral: Diet CounselingParticipants will receive only the one time standard of care in-clinic diet counseling at visit 1. |
| Experimental CD Low Fat Diet (LFD) Group | Experimental | Other: CD LFDParticipants will be provided catered LFD meals for 8 consecutive weeks consisting of daily breakfast, lunch, dinner and snacks. |
| Experimental CD LFD + DPS Group | Experimental | Other: CD LFD, Behavioral: Dyadic Psychological Support (DPS)Participants and one family member that lives with them will be provided catered LFD meals for 8 consecutive weeks consisting of daily breakfast, lunch, dinner and snacks. In addition, the participant and their family member will receive 12 consecutive weeks of Dyadic Psychological Support (DPS). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or Female ≥18 and ≤70 years old and lives with someone that is involved in daily diet
- Documented diagnosed of Crohn's Disease
- sCDAI less than 400
- Patients on oral 5-aminosalicylates, mesalamine or sulfasalazine must be on a stable dose for ≥2 weeks prior to screening
- Treated with anti-Tumor Necrotic Factors (TNFs) or immunosuppressants (AZA, 6-Mercaptopurine (6-MP), or methotrexate) at screening must have been on a stable dose for ≥4 weeks
Key exclusion criteria (21 listed)
- Patients with Ulcerative Colitis and Celiac Disease
- Abdominal abscess, symptomatic Intestinal stricture, patients with altered anatomy: prior total colectomy or proctocolectomy or anticipated colectomy during the study period and presence of ileal pouch or ostomy
- Other clinically meaningful laboratory abnormalities: pregnancy or lactation, an unstable or uncontrolled medical disorder, colonic dysplasia or adenomas, and malignant neoplasms. Toxic megacolon situations such as Patients with short life expectancy
- Use of cyclosporine, mycophenolate mofetil, sirolimus, thalidomide or tacrolimus within 2 months prior to screening
- Need for prednisone > 20 mg daily or budesonide > 9 mg 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
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 |
|---|---|---|
| Diet CounselingStandard of care diet counseling provided at clinic visit 1. | Behavioural | Crohn's Disease (CD) Control Group |
| CD LFDDaily breakfast, lunch, dinner and snacks LFD catered meals. Meals will have approximately 20% calories from fat, a goal ratio close to 1:1 omega-6/omega-3 fatty acids, and approximately 25-35 grams of fiber per day. | Other | Experimental CD LFD + DPS Group, Experimental CD Low Fat Diet (LFD) Group |
| Dyadic Psychological Support (DPS)The dyadic psychosocial support (DPS) intervention will be provided for a total of 12 weeks. The 12-week DPS intervention consists of eight sessions (main sessions) and two booster sessions. The intervention will incorporate psychoeducational components that combine didactic and behavioral regulatory procedures to promote healthy diet behavior for self-determined reasons. | Behavioural | Experimental CD LFD + DPS Group |
Primary outcome
Change in fat intake
Time frame: Baseline, 8 weeks
Change in daily fat intake calculated through patient reported diet diary app Nutrihand.
Rate of adherence to fat intake
Time frame: Week 36
Adherence to fat intake is measured by the web-based Automated Self-Administered 24-hour diet recall (ASA24).
7 secondary outcomes
Change in clinical symptoms as assessed by Patient Reported Outcomes (PRO2).
Time frame: Baseline, Week 8
Change in clinical symptoms as assessed by the Harvey Bradshaw Index (HBI)
Time frame: Baseline, Week 8
Change in clinical symptoms as assessed by the Short Crohn's Disease Activity Index (sCDAI).
Time frame: Baseline, Week 8
Change in quality of life (QoL) as assessed by the Short Inflammation Bowel Disease Questionnaire (sIBDQ).
Time frame: Baseline, Week 8
Change in quality of life (QoL) as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29).
Time frame: Baseline, Week 8
Change in the expression of cytokine high-sensitivity C-reactive protein (hsCRP).
Time frame: Baseline, Week 8
Change in the expression of Serum Amyloid A (SAA).
Time frame: Baseline, Week 8
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 29 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Crohn Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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 T 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 Diet Counseling, CD LFD and Dyadic Psychological Support (DPS) in people with Crohn Disease, 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 21 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 29 Feb 2024. 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 fat intake (time frame: Baseline, 8 weeks). The study lists 2 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 29 Feb 2024.