The primary objective is to investigate the potential effect of the AIDP on global functioning in patients with SSD, BD, AD, and PD. Secondary objectives are to investigate whether the AIDP has a beneficial effect on cognitive functioning, well-…
ID
Source
Brief title
Condition
- Other condition
- Schizophrenia and other psychotic disorders
Synonym
Health condition
bipolaire stoornis; dementie door de ziekte van Alzheimer; de ziekte van Parkinson
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is global functioning assessed with Outcome Questionnaire 45
(OQ45).
Secondary outcome
Secondary outcomes are global functioning (assessed with Global Assessment of
Functioning, (GAF), and Individual Recovery Outcomes Counter (I.ROC)),
cognitive functioning (Brief Assessment of Cognition (BAC), Stroop Task and
Trail making task), well-being (Health-related quality of life assessed with
EuroQoL 5D, EQ-5D), and fatigue (Short Fatigue Questionnaire, SFQ).
Furthermore, we will assess various immunological and inflammation parameters
(in blood), gut health (intestinal permeability with biomarkers in blood and
gut microbiome composition and metabolomics in faeces samples), and GI symptoms
(Gastrointestinal Symptom Rating Scale, GSRS + Bristol Stool chart).
Additionally, we will examine general physical health (Body Mass Index, BMI),
metabolic syndrome features (waist and hip circumference, blood pressure,
glucose and triglycerides), and physical activity (using the BAECKE
questionnaire). We also assess disease-specific symptom severity (for SSD and
BD the Brief Psychiatric Rating Scale (BPRS); for AD Instrumental Activity of
Daily Living Questionnaire (IADL); and for PD Movement Disorders Society
Unified Parkinson Disease Rating Scale (MDS-UPDRS) part III (motor examination)
and Non-Motor Symptom Questionnaire, NMSQ). Furthermore, in the BD and SSD
groups we assess stress and stress resilience using the short version of the
Childhood Trauma Questionnaire (CTQ-SF), the Brugha List of Threatening
Experiences, the 10-point version of the Perceived Stress Scale (PSS-10), and
the Brief Resilience Scale (BRS), as well as by collecting heart rate
variability (HRV) measures in rest using electrocardiography (ECG). Finally, as
an optional measurement, we assess oral health, screened with an oral self-care
questionnaire (OZ Pruntel), Oral Health Impact Profile questionnaire (OHIP),
intra-oral photographs and by taking samples of the composition of the oral
microbiome (by mouth rinse and swab).
Background summary
Schizophrenia spectrum disorders (SSD), bipolar disorder (BD), Alzheimer*s
disease (AD), and Parkinson's disease (PD) are common brain disorders, which
can severely affect patients* functioning and quality of life, with significant
burden on global health. Although these four disorders are rather different,
cognitive dysfunction and decreased mood are common in all four disorders.
Another communality is that gastrointestinal (GI) symptoms are frequent in
these disorders. Recent investigations have pointed to the gut-brain axis as a
new venue for disease-modifying treatment of brain disorders, with increased
systemic inflammation stemming from increased intestinal permeability to affect
brain functioning in a significant subset of patients. Gut health therefore
opens a new therapeutic window, in which an anti-inflammatory dietary pattern
(AIDP) may modify the course of brain disorders. By affecting the gut-brain
axis, we expect direct effects on disability and symptoms of brain disorders,
as brain homeostasis and plasticity may benefit from a lower inflammatory
status. Reducing the body*s inflammatory status can also improve mood,
cognition, well-being, stress and stress resilience, and oral health.
Study objective
The primary objective is to investigate the potential effect of the AIDP on
global functioning in patients with SSD, BD, AD, and PD. Secondary objectives
are to investigate whether the AIDP has a beneficial effect on cognitive
functioning, well-being, fatigue, gut health (intestinal permeability and gut
microbiome composition), in addition to GI symptoms, general health (BMI,
somatic comorbidity, and presence and severity of metabolic syndrome features),
disease-specific symptom severity, and stress and stress resilience. This
project aims to provide a safe and well-tolerated dietary intervention to
improve global functioning. Furthermore, knowledge will be gained on the oral
health status and the composition of the oral microbiome in all diagnoses.
Study design
Randomized controlled open label trial with cross-over intervention of 12 weeks
and wash-out period of 24 weeks.
Intervention
Per diagnostic group patients are 1:3 randomized to group 1 starting with the
AIDP at baseline period 1, those randomized to group 2 will start the AIDP at
week 36. Outcome measurements will be assessed at baseline period 1 (visit 1),
week 12 (visit 2), 24 (visit 3), 36 (baseline period 2, visit 4), 48 (visit 5),
and 60 (visit 6).
Study burden and risks
Participants will undergo the same measurements 6 times at home or at the UMC
Groningen. Therewith they will face the (small) burden that comes with clinical
visits, blood- and faeces sampling and filling out several questionnaires. The
risk and burden from blood drawings are low (e.g., irritation/ hematoma). The
burden and risks are considered to be acceptable, while the benefits are
expected to be considerable, as both groups will receive the AIDP. Potential
benefits may be higher quality of life, better well-being and general health.
During the AIDP, participants will be provided with free nutrition during 12
weeks, which will be a considerable saving post for them.
For the participants in the BD and SSD groups, a baseline HRV measurement will
be conducted during all measurements. The burden and risk for this measurement
are considered quite low, as ECG is a non-invasive measurement method, the
measurement including preparations takes 15 minutes on average, and the
participant does not need to perform any task during the measurement.
Besides the psychiatric and dietary assessments, an optional oral health
assessment will be performed. The extra oral health assessments will be
assessed only during the regular pre- and post-dietary intervention visits; for
group 1 at visit 1 and 2, for group 2 at visit 4 and 5. The burden and risks
are considered as low, while the benefit for the patients is that they will be
informed about their oral health and that they will receive oral health care
advice (recommendations will be given also on paper) when oral health is at
risk or considered to be poor.
Antonius Deusinglaan 2
Groningen 9713AW
NL
Antonius Deusinglaan 2
Groningen 9713AW
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
1. Clinical diagnosis made by medical specialist of schizophrenia,
schizophreniform disorder, schizoaffective disorder, bipolar disorder type 1 or
type 2, Alzheimer's disease or Parkinson's disease.
2. The participant is living in Drenthe, Friesland or Groningen.
3. The participant has the cognitive capacity* to understand what participation
means, which is confirmed by clinical view of medical specialist. The
participant is able and willing to provide IC.
4. Age between 18 and 80 years and sufficient command of the Dutch language.
5. Motivated and capable to use the dietary pattern (use food from the boxes)
and participate in interview visits at home. The partner or other household
members should support participation, or at least not be opposed to
participation.
6. The participant has the ability to consume foods as prescribed, without
religious, medical or sociocultural factors precluding participation or
adherence to the diet.
7. The participant lives independently (not in nursing home etc.) and is
willing and able to prepare fresh meals using standard kitchen equipment.
*A participants* legal capacity will be tested during the informed consent
procedure and will be repeated halfway through the study (during the washout
period, visit 3)
When a participant is or becomes incapable during the study, he/she will be
excluded from further participation.
Exclusion criteria
If a potential subject meets any of the following criteria participation is not
possible:
1. Pregnancy or breast-feeding (or foreseen pregnancy during study period).
2. Severe under- or overweight needing medical treatment (evaluated by GI
specialists).
3. Severe bowel or liver diseases or acute/chronic pancreatitis (evaluated by
GI specialists).
4. Impossible to consume exclusively delivered products due to medical reasons
(e.g. allergy for nuts or other nutrients), following a special diet that
cannot be combined with AIDP (e.g. for diabetes or food intolerance) or certain
food preferences (e.g. vegan diet, vegetarian, or don*t eat fish).
5. Already consuming an AIDP on own initiative (evaluated with Dutch Healthy
Diet-Food Frequency Questionnaire (DHD-FFQ)).
6. Current use of antibiotics (or less than 4 weeks ago), regular use of
probiotics (i.e. Yakult, Vifit, Activia) or specific prebiotics supplements and
are not willing to refrain 6 weeks prior to the start of and during the entire
study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL78755.056.21 |
| OMON | NL-OMON20827 |