Psychiatric and neurodegenerative disorders Psychiatric and neurodegenerative disorders
Conditions
Interventions
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 asse
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is global functioning assessed with Outcome Questionnaire 45 (OQ45). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Netherlands
Contacts
Public ContactB Smid
Universitair Medisch Centrum Groningen
Outcome results
None listed