Efficacy of an anti-inflammatory diet on global functioning, gut microbiome and health of patients with schizophrenia spectrum disorder, bipolar disorder, Alzheimer*s disease or Parkinson*s disease: a randomized controlled trial

Phase 3

Recruiting

• Conditions: bipolaire stoornis; dementie door de ziekte van Alzheimer; de ziekte van Parkinson; Psychiatric and neurodegenerative disorders; 10039628

• Registration Number: NL-OMON52339
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 100

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome is global functioning assessed with Outcome Questionnaire 45<br /><br>(OQ45).</p><br>