Crohn DiseaseVita-GrAIDNCT04913467
Effect of Ileocolonic Delivered Vitamins and an Anti-Inflammatory Diet on Crohn's Disease and Healthy Volunteers
A study testing Groningen Anti-Inflammatory Diet (GrAID) and ColoVit capsule in people with Crohn Disease, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
This study will evaluate if the Groningen Anti-Inflammatory Diet and the ileocolonic delivery of vitamin B2, B3 and C can positively influence the course of Crohn's disease and can positively alter the gut microbiome of Crohn's disease patients as well as healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Groningen Anti-Inflammatory Diet (GrAID) and ColoVit capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 510 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Oct 2021to 1 Jul 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant understands the study procedures and signed an informed consent to participate in this study
- Previously diagnosed with CD; Montreal classification: L1 (Ileal), L2 (colonic), or L3 (ileocolonic).
- Low-mild disease activity (no clinically relevant symptoms and HBI<8 or CDAI <220)
- Evidence of mucosal inflammation (faecal calprotectin ≥100 μg/g)
- Able to attend to the outpatient clinic of the UMCG, Martini Hospital, MCL Leeuwarden or Isala
- ≥18 years of age
Show all 13Show fewer
- Able to use oral feeding and willing to undergo a dietary intervention (Follow a diet or use a vitamin B2/B3/C supplement or placebo)
- Participant understands the study procedures and signed an informed consent to participate in this study
- Never been diagnosed with IBD or any other chronic inflammatory condition.
- Participant has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the investigator on the basis of medical history and routine laboratory test results.
- Able to attend to the outpatient clinic of the UMCG, Martini Hospital, MCL Leeuwarden or Isala
- ≥18 year of age
- Able to use oral feeding and willing to undergo a dietary intervention (Follow a diet or use a vitamin B2/B3/C supplement or placebo)
Who cannot join
- Life expectancy <12 months
- Active Crohn's disease (HBI≥8 or CDAI>220), or expecting drug intervention within 3 months
- Colonoscopy and colon cleansing in the past 3 months;
- Use antibiotics, probiotics (eg Yakult, Vifit, Activia) or specific prebiotics supplements 3 weeks prior to the start of the intervention
- Use of vitamin/mineral supplements 1 week prior to the start of the intervention (except for vitamin D and/or calcium)
- Use Methotrexate drugs or chronic use of antacids, H2 or proton-pump inhibitors
Show all 28Show fewer
- With a history of GI disorders or GI surgery that are likely to interfere with the pH-dependent mode of action of the Colovit-capsule
- Patients with a pouch or stoma
- Pregnant or breastfeeding (or foreseen pregnancy during dietary intervention period)
- Swallowing disorders, not able to tolerate oral food, or use of tube feeding (EEN)
- Previously proven anaphylactic reaction to foods included in the food boxes
- Previously diagnosed with Celiac Disease or following a gluten-free diet
- Following a vegetarian or vegan diet
- Life expectancy <12 months
- Previously diagnosed with IBD or any other chronic inflammatory condition
- Colonoscopy and colon cleansing in the past 3 months;
- Use antibiotics, probiotics (eg Yakult, Vifit, Activia) or specific prebiotics supplements 3 weeks prior to the start of the intervention
- Use of vitamin/mineral supplements 1 week prior to the start of the intervention (except for vitamin D and/or calcium)
- With a history of GI disorders or taken drugs that are likely to interfere with mode of action of interventions, such as chronic use of antacids or proton-pump inhibitors
- Abnormal clinical chemistry and haematology laboratory test results of clinical significance that in the judgment of the investigator would interfere with the participant's ability to comply with the study protocol (which might confound the interpretation of the study results), or put the participant at undue risk.
- Presence of a stoma
- History or presence of cancer in the prior two years, except for non-melanoma skin cancer.
- Recent history of (within 12 months of screening visit) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as >60g (men) / 40g (women) pure alcohol per day (1.5 l / 1 l beer resp. 0.75 l / 0.5 l wine).
- Pregnant or breastfeeding (or foreseen pregnancy during dietary intervention period) The method of contraception must be recorded in the source documentation.
- Swallowing disorders, not able to tolerate oral food, or use of tube feeding (EEN)
- Previously proven anaphylactic reaction to foods included in the food boxes
- Previously diagnosed with Celiac Disease or following a gluten-free diet
- Following a vegetarian or vegan diet
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, 9713GZ
Gerard Dijkstra, Md PhD, +31 050 3612620, gerard.dijkstra@umcg.nl
About this study
Official title: Potential Effects of Ileocolonic Delivered Vitamins or the Groningen Anti-Inflammatory Diet on Course of Crohn's Disease and the Microbiome of Healthy Volunteers: a Randomized Controlled Trial - The Vita-GrAID Study
This study will evaluate if the Groningen Anti-Inflammatory Diet and the ileocolonic delivery of vitamin B2, B3 and C can positively influence the course of Crohn's disease and can positively alter the gut microbiome of Crohn's disease patients as well as healthy volunteers.
Read the detailed description
It is becoming increasingly more well known that diet and the microbiome have a pivotal role in the development and course of inflammatory bowel diseases (IBD). Strict exclusive enteral nutrition (EEN) can induce remission in Crohn's Disease (CD) and is the standard treatment in paediatric CD. Implementing a restrictive diet in adults is difficult; adult patients do not tend to adhere to EEN. Recently, the CD-exclusion diet (CDED) combined with partial enteral nutrition demonstrated to be effective in CD-patients with flares.
Additionally, accumulating evidence suggests that intake of vitamins can influence disease course, mainly by beneficially modulating the gut microbiota and gut redox potential, especially if the vitamins can be delivered to the colon.
Nevertheless, no dietary guidelines are available to physicians and patients. Due to complaints of certain foods and patients' eagerness to postpone new flares, patients start experimenting with their food. As patients with CD are already often malnourished, this poorly substantiated experimenting puts them even more at risk for malnutrition and could have a potential negative effect on their disease outcomes. Next, quality of life of patients decreases and healthcare costs will rise. Therefore, both patients and physicians are in desperate need of evidence for an anti-inflammatory dietary advice in CD. As compliance to a diet increases when they are supported by family members, their household members will also be asked to participate in the study. Simultaneously studying their healthy family members will also provide information of the effect of this anti-inflammatory diet or intake of lieocolonic-delivered vitamins on their microbiome and markers of inflammation and oxidative stress.
- Conditions
- Crohn Disease
- Being tested
- Groningen Anti-Inflammatory Diet (GrAID), ColoVit capsule, ColoPulse-placebo capsule
- Keywords
- Inflammatory Bowel Disease, IBD, Crohn, Vitamins, Diet, Riboflavin, Ascorbic Acid, Niacin, Microbiome
- 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.
Groningen Anti-Inflammatory Diet (GrAID)Other
Specially designed diet based on the most recent scientific evidence of the inflammatory characteristics of food and food groups. Basically, subjects will be instructed to increase uptake of food components that hold potential anti-inflammatory proportions and to avoid food components that may showcase potential pro-inflammatory proportions.
ColoVit capsuleDietary supplement
Vitamin B2/B3/C supplement in a ColoPulse-coated capsule
ColoPulse-placebo capsuleOther
A capsule containing microcrystalline cellulose which is coated using the same ColoPulse technology as is used with the ColoVit
| Study group | Role | What they receive |
|---|---|---|
| Groningen Anti-Inflammatory Diet (GrAID) | Experimental | Specially designed diet based on the most recent scientific evidence of the inflammatory characteristics of food and food groups. Receives: Other: Groningen Anti-Inflammatory Diet (GrAID) |
| ColoVit capsule | Experimental | 2 times daily intake of a supplement containing 37,5 mg vitamin B2, 2,5 mg vitamin B3 and 250 mg vitamin C in a ColoPulse-coated capsule, a pH-sensitive coating allowing ileocolonic-targeted-delivery Receives: Dietary Supplement: ColoVit capsule |
| Placebo capsule | Placebo comparator | 2 times daily intake of a capsule containing microcrystalline cellulose which is coated using the same ColoPulse technology as is used with the ColoVit Receives: Other: ColoPulse-placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in faecal calprotectin
Primary outcome for CD patients
Measured: Faeces sample collection at 4 time points: At baseline (0 months), after 3 months, after 6 months, after 12 months
Change in microbiome composition measured by metagenomic sequencing- based profiles
Primary outcome for healthy volunteers and CD patients
Measured: Faeces sample collection at 3 time points: At baseline (0 months), after 3 months, after 12 months
Secondary outcomes (4)
The number of flares (defined as faecal calprotectin >200 μg/g and Crohn's Disease Activity Index (CDAI) ≥220 points)
Secondary outcome for CD patients
Measured: Faeces sample collection and CDAI score determination at 4 time points: At baseline (0 months), after 3 months, after 6 months, after 12 months
Improvements of Quality of life scores as assessed by Inflammatory Bowel Disease Questionnaire (Score range of 32-224, The higher the score the higher the Quality of Life)
Secondary outcome for CD patients
Measured: Questionnaires at 3 time points: At baseline (0 months), after 3 months, after 12 months
Improvements of Quality of life scores as assessed Food Related Quality of Life Questionnaire (Score range of 29-145, The higher the score the higher the Food related-Quality of Life)
Secondary outcome for CD patients and healthy volunteers
Measured: Questionnaires at 3 time points: At baseline (0 months), after 3 months, after 12 months
Adherence to the dietary interventions as assessed by a Dietary Compliance Questionnaire
Secondary outcome for CD patients and healthy volunteers
Measured: Questionnaires at 3 time points: At baseline (0 months), after 3 months, after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start8 Oct 2021
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2025 (estimated)
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 Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, partly blinded, multicenter clinical food trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 510 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. dr. G. Dijkstra, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913467
- Sponsor's protocol ID
- NL66008.056.20
- Other IDs
- 202000683
- Acronym
- Vita-GrAID
- Status last verified
- Feb 2023
- First submitted
- 3 May 2021
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers outside of the study team.
Publications
Otten AT, Peters V, Barth I, Stevens CL, Bourgonje AR, Frijlink HW, Harmsen HJM, Rehman A, Campmans-Kuijpers MJE, Dijkstra G. Effects of ileocolonic delivered vitamin B2, B3 and C (ColoVit) or the Groningen anti-inflammatory diet on disease course and microbiome of patients with Crohn's disease (VITA-GrAID study): a protocol for a randomised and partially blinded trial. BMJ Open. 2023 Mar 14;13(3):e069654. doi: 10.1136/bmjopen-2022-069654.
PubMed 36918234
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Effects of Ileocolonic Delivered Vitamins or the Groningen Anti-Inflammatory Diet on Course of Crohn's Disease and the Microbiome of Healthy Volunteers: a Randomized Controlled Trial - The Vita-GrAID Study
- ClinicalTrials.gov ID
- NCT04913467
- Acronym / sponsor ID
- Vita-GrAID / NL66008.056.20
- Conditions
- Crohn Disease
- Keywords
- Inflammatory Bowel Disease, IBD, Crohn, Vitamins, Diet, Riboflavin, Ascorbic Acid, Niacin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 510 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 4 Jun 2021 (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.
This study will evaluate if the Groningen Anti-Inflammatory Diet and the ileocolonic delivery of vitamin B2, B3 and C can positively influence the course of Crohn's disease and can positively alter the gut microbiome of Crohn's disease patients as well as healthy volunteers.
Detailed description
It is becoming increasingly more well known that diet and the microbiome have a pivotal role in the development and course of inflammatory bowel diseases (IBD). Strict exclusive enteral nutrition (EEN) can induce remission in Crohn's Disease (CD) and is the standard treatment in paediatric CD. Implementing a restrictive diet in adults is difficult; adult patients do not tend to adhere to EEN. Recently, the CD-exclusion diet (CDED) combined with partial enteral nutrition demonstrated to be effective in CD-patients with flares.
Additionally, accumulating evidence suggests that intake of vitamins can influence disease course, mainly by beneficially modulating the gut microbiota and gut redox potential, especially if the vitamins can be delivered to the colon.
Nevertheless, no dietary guidelines are available to physicians and patients. Due to complaints of certain foods and patients' eagerness to postpone new flares, patients start experimenting with their food. As patients with CD are already often malnourished, this poorly substantiated experimenting puts them even more at risk for malnutrition and could have a potential negative effect on their disease outcomes. Next, quality of life of patients decreases and healthcare costs will rise. Therefore, both patients and physicians are in desperate need of evidence for an anti-inflammatory dietary advice in CD. As compliance to a diet increases when they are supported by family members, their household members will also be asked to participate in the study. Simultaneously studying their healthy family members will also provide information of the effect of this anti-inflammatory diet or intake of lieocolonic-delivered vitamins on their microbiome and markers of inflammation and oxidative stress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, partly blinded, multicenter clinical food trial
| Arm | Type | Receives |
|---|---|---|
| Groningen Anti-Inflammatory Diet (GrAID) | Experimental | Other: Groningen Anti-Inflammatory Diet (GrAID)Specially designed diet based on the most recent scientific evidence of the inflammatory characteristics of food and food groups. |
| ColoVit capsule | Experimental | Dietary Supplement: ColoVit capsule2 times daily intake of a supplement containing 37,5 mg vitamin B2, 2,5 mg vitamin B3 and 250 mg vitamin C in a ColoPulse-coated capsule, a pH-sensitive coating allowing ileocolonic-targeted-delivery |
| Placebo capsule | Placebo comparator | Other: ColoPulse-placebo capsule2 times daily intake of a capsule containing microcrystalline cellulose which is coated using the same ColoPulse technology as is used with the ColoVit |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Participant understands the study procedures and signed an informed consent to participate in this study
- Previously diagnosed with CD; Montreal classification: L1 (Ileal), L2 (colonic), or L3 (ileocolonic).
- Low-mild disease activity (no clinically relevant symptoms and HBI<8 or CDAI <220)
- Evidence of mucosal inflammation (faecal calprotectin ≥100 μg/g)
- Able to attend to the outpatient clinic of the UMCG, Martini Hospital, MCL Leeuwarden or Isala
Key exclusion criteria (28 listed)
- Life expectancy <12 months
- Active Crohn's disease (HBI≥8 or CDAI>220), or expecting drug intervention within 3 months
- Colonoscopy and colon cleansing in the past 3 months;
- Use antibiotics, probiotics (eg Yakult, Vifit, Activia) or specific prebiotics supplements 3 weeks prior to the start of the intervention
- Use of vitamin/mineral supplements 1 week prior to the start of the intervention (except for vitamin D and/or calcium)
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 |
|---|---|---|
| Groningen Anti-Inflammatory Diet (GrAID)Specially designed diet based on the most recent scientific evidence of the inflammatory characteristics of food and food groups. Basically, subjects will be instructed to increase uptake of food components that hold potential anti-inflammatory proportions and to avoid food components that may showcase potential pro-inflammatory proportions. | Other | Groningen Anti-Inflammatory Diet (GrAID) |
| ColoVit capsuleVitamin B2/B3/C supplement in a ColoPulse-coated capsule | Dietary supplement | ColoVit capsule |
| ColoPulse-placebo capsuleA capsule containing microcrystalline cellulose which is coated using the same ColoPulse technology as is used with the ColoVit | Other | Placebo capsule |
Primary outcome
Change in faecal calprotectin
Time frame: Faeces sample collection at 4 time points: At baseline (0 months), after 3 months, after 6 months, after 12 months
Primary outcome for CD patients
Change in microbiome composition measured by metagenomic sequencing- based profiles
Time frame: Faeces sample collection at 3 time points: At baseline (0 months), after 3 months, after 12 months
Primary outcome for healthy volunteers and CD patients
4 secondary outcomes
The number of flares (defined as faecal calprotectin >200 μg/g and Crohn's Disease Activity Index (CDAI) ≥220 points)
Time frame: Faeces sample collection and CDAI score determination at 4 time points: At baseline (0 months), after 3 months, after 6 months, after 12 months
Improvements of Quality of life scores as assessed by Inflammatory Bowel Disease Questionnaire (Score range of 32-224, The higher the score the higher the Quality of Life)
Time frame: Questionnaires at 3 time points: At baseline (0 months), after 3 months, after 12 months
Improvements of Quality of life scores as assessed Food Related Quality of Life Questionnaire (Score range of 29-145, The higher the score the higher the Food related-Quality of Life)
Time frame: Questionnaires at 3 time points: At baseline (0 months), after 3 months, after 12 months
Adherence to the dietary interventions as assessed by a Dietary Compliance Questionnaire
Time frame: Questionnaires at 3 time points: At baseline (0 months), after 3 months, after 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Derived from this study: PubMed 36918234Otten AT, Peters V, Barth I, Stevens CL, Bourgonje AR, Frijlink HW, Harmsen HJM, Rehman A, Campmans-Kuijpers MJE, Dijkstra G. Effects of ileocolonic delivered vitamin B2, B3 and C (ColoVit) or the Groningen anti-inflammatory diet on disease course and microbiome of patients with Crohn's disease (VITA-GrAID study): a protocol for a randomised and partially blinded trial. BMJ Open. 2023 Mar 14;13(3):e069654. doi: 10.1136/bmjopen-2022-069654.
- Individual participant dataSharing planned: 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Groningen Anti-Inflammatory Diet (GrAID) and ColoVit capsule in people with Crohn Disease, run by University Medical Center Groningen at 1 site in Netherlands.
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 13 inclusion and 28 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 14 Feb 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 Netherlands. 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. Some participants in this study may receive a placebo. 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 Gerard Dijkstra, MD PhD (+31 050 3612620, gerard.dijkstra@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in faecal calprotectin (time frame: Faeces sample collection at 4 time points: At baseline (0 months), after 3 months, after 6 months, after 12 months). 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?
On the ClinicalTrials.gov record for NCT04913467, 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 14 Feb 2023.