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NCT04330703: MMM

Meals, Microbiota & Mental Health of Children & Adolescents

Not yet recruiting Last updated 8 February 2024
What this trial tests

trial in Mental Disorder in 30 participants. Not yet recruiting.

Timeline
15 March 2024
Primary endpoint
15 March 2025
31 December 2026

Quick facts

Lead sponsorUniversity of Iceland
StatusNot yet recruiting
Study typeOBSERVATIONAL
Enrollment30
Start date15 March 2024
Primary completion15 March 2025
Estimated completion31 December 2026

Conditions studied

Sponsor

University of Iceland

Who can join

Adults 5 to 15, any sex, with Mental Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Recent studies indicate that the interplay between diet, intestinal microbiota composition, and intestinal permeability might impact mental health. The aim of thisl study is to compare diet, intestinal microbiota, intestinal permeability, and related metabolic factors among children and adolescents diagnosed with mental health disorders and control groups and identify potential relationship patterns. All children and adolescents referred to the outpatient clinic at the Child and Adolescent Psychiatry Department at The National University Hospital in Reykjavik Iceland will be offered to participate (n=15) (age 5-15 years). Two control groups will be used; the same parent siblings close in age (n=x) as well as age and sex-matched children from the same postal area (n=15). A three-day food diary, rating scales for mental health and multiple questionnaires will be completed as well as faecal sample, buccal swab, urine, saliva and blood samples will be collected. This is a novel approach as more multidimensional transdisciplinary studies including longitudinal observational data have been called for as a basis for lifestyle treatment options for improving mental health and wellness.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Predispose, precipitate, perpetuate, and protect: how diet and the gut influence mental health in emerging adulthood.
    Warren M, O'Connor C, Lee JE, Burton J, et al · · 2024 · cited 5× · PMID 38505265 · DOI 10.3389/fnut.2024.1339269
  2. Meals, Microbiota and Mental Health in Children and Adolescents (MMM-Study): A protocol for an observational longitudinal case-control study.
    Asbjornsdottir B, Lauth B, Fasano A, Thorsdottir I, et al · · 2022 · cited 3× · PMID 36048886 · DOI 10.1371/journal.pone.0273855

Verify or expand the search:

Other recruiting trials for Mental Disorder

Currently open trials in the same condition.

Other University of Iceland trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04330703.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing