The main aim is to investigate the effect of a dietary intervention on CD patients and healthy volunteers. The dietary interventions consist of the Groningen anti-inflammatory diet (GrAID) and a vitamin B2/B3/C supplement (ColoVit) and they will be…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoints are divided into three research areas and differs for
patients and healthy participants. Overview of measurements conducted in CD
patients and healthy participants can be found in more detail in the protocol.
Clinical objective:
a. the number of flares (defined as faecal calprotectin >200 µg/g and CDAI
>=220) (secondary outcome CD patients), measured after 3, 6 and 12 months
b. the quality of life (IBDQ), at 0, 3, 6 and 12 months
Mechanical objective
c. faecal sampling: the composition of microbiota and microbiome diversity
(primary outcome for healthy participants) at 0, 3, and 12 (only in GrAID)
months
d. faecal parameters: calprotectin (primary outcome for IBD patients), faecal
pH, Short Chain Fatty Acids (SCFAs), faecal redox potential (secondary outcome)
at 0, 3 and 12(only in GrAID) months
e. Inflammatory parameters (CRP) and redox parameters (free thiols) (blood
samples) at 0, 3, 6 and 12 months in CD patients and at 0 and 3 months in
healthy participants
Societal objective:
f. compliance outcomes: follow-up compliance. (at 3 months for all groups and
at 6 and 12 months for the dietary group)
Secondary outcome
See primary study parameters for a quick overview and please refer to the
protocol for a more elaborate overview of the endpoints and parameters)
Background summary
No evidence based dietary guidelines are currently provided by physicians to
patients with Crohn*s Disease (CD). Subsequently, unguided dietary habits are
adapted by patients. These habits potentially affect their disease course
negatively and put patients at risk for malnutrition. Next, quality of life of
patients decreases and healthcare costs will rise. Therefore, both patients and
physicians are in desperate need of evidence on the role of nutrition in CD.
Multiple foods and food supplements have been identified as potential positive
influencers of disease and general well being. In this randomized controlled
trial we will examine the effects of a two dietary interventions: A specially
developed anti-inflammatory diet (GrAID) and a vitamin B2/B3/C supplement
(ColoVit). We will primarily investigate the effect of the dietary
interventions on the course of CD. Furthermore, we study the adherence to the
anti-inflammatory diet and we investigate the effects of the nutritional
intervention on the microbiome of CD patients and healthy volunteers
Study objective
The main aim is to investigate the effect of a dietary intervention on CD
patients and healthy volunteers. The dietary interventions consist of the
Groningen anti-inflammatory diet (GrAID) and a vitamin B2/B3/C supplement
(ColoVit) and they will be compared to a placebo capsule
The primary aim is divided into three sub-aims:
1. Clinical aim: To investigate wether the dietary interventions are capable of
reducing the number of flares in CD patients and capable of improving the
quality of life CD patients and healthy volunteers
2. Mechanical endpoints: To investigate wether the dietary interventions are
capable of positively influencing microbiome composition and diversity and is
capable of reducing inflammationmarkers in blood and feces.
3. Societal endpoints: Dietary intervention compliance
Study design
We will perform double blinded placebo-controlled randomized clinical trial
(RCT) in both Crohn's Disease patients and healthy volunteers. Patients will be
randomized into three intervention groups (GrAID, ColoVit or Placebo).
Family members of Crohn's disease patients will be asked to participate in the
trial as healthy volunteers. They will receive the same intervention as which
their partner with CD will be randomized for.
Intervention
Intervention:
- Group 1 who will follow the Groningen Anti-Inflammatory diet (GrAID) and
receive a food box for three months
- Group 2 who will receive a vitamin B2/B3/C delivered to the ileocolonic
region (ColoVit) supplement for 3 months
- Group 3 who will receive a placebo for 3 months
All groups will consist of patients with Crohn Disease and healthy volunteers
Study burden and risks
The burden of participating in this study does slightly differ for the
participants in the different dietary intervention groups.. All participants
will undergo the same measurements at multiple time-points and will therewith
face the (small) burden that comes with clinical visits (3-4x), blood-, urine-
and faeces sampling (3x-4), and filling out several questionnaires. The time
investment for this study is estimated to be 20 hours spread over a period of 1
year, which is considered reasonable. the participants in group 1 will carry an
additional burden when it comes to adapting to an anti-inflammatory diet,
compared to group 2 and 3 who will be asked to swallow a capsule 2 times a day.
The participants in group 1 will be restricted in their freedom of food choice,
it can be inconvenient to eat out of the food boxes in terms of taste of the
predetermined meals and matching preparation time. In contrast, the provided
food boxes can also be useful in terms of regained/saved shopping time,
inspiration due to new dishes, and exploring new flavours or taste. In
addition, for three months the food boxes will be provided for a two-persons
household at no costs. The proposed aim of the dietary interventions can also
be seen as a benefit; the prevention of disease flares as well as improving of
quality of life. A benefit for the participants in the cohort group, at the end
of the study an insight will be given in their personal results on nutritional
status and other measurements over the past year.
Hanzeplein 1
Groningen 9700RB
NL
Hanzeplein 1
Groningen 9700RB
NL
Listed location countries
Age
Inclusion criteria
Patients are eligible to participate in this study if they meet all of the
following criteria:
• Signed an informed consent
• Previously diagnosed with CD
• Low-mild disease activity (no clinically relevant symptoms and HBI<8)
• Evidence of mucosal inflammation (faecal calprotectin >=100 µg/g)
• Able to attend to the outpatient clinic
• >18 years of age
• Able to use oral feeding and willing to undergo a dietary intervention (use
food out of the food boxes or use a vitamin B2/B3/C supplement or placebo)
Concomitant medication for CD is allowed (except for Methotrexate drugs, see
exclusion criteria) and will be continued and monitored during the complete
study.
Healthy participants are eligible to participate in this study if they meet all
the following criteria:
• Signed an informed consent
• Never been diagnosed with IBD
• Able to attend to the outpatient clinic
• >=18 year of age
• Able to use oral feeding and willing to undergo a dietary intervention (use
food out of the food boxes or use a vitamin B2/B3/C supplement or placebo)
Exclusion criteria
Patients and healthy volunteers will be excluded from the study is they meet
any of the following criteria:
• 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 proton pump inhibitors
• GI resection or a history of GI conditions that in the judgment of the
investigator could possibly interfere with the working mechanism of the
pH-sensitive ColoPulse coating
• Patients with a pouch or stoma
• Pregnant or breastfeeding
• 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 Coeliac Disease
• Following a vegetarian or vegan diet
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL66008.056.20 |