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Food4Mood

Dietary modulation of the gut-brain axis to improve mental health - Food4Mood

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON61366
Enrollment
180
Registered
2025-07-07
Start date
2026-10-11
Completion date
Unknown
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emotional state, affect, feelings How you feel

Interventions

Four active supplements (probiotic, vitamin, and two post-biotics) versus placebo, combined with a plant-based high-fibre diet. One control group receives general dietary advice plus placebo.

Sponsors

Wageningen Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Men / women between 18-25 yMild-moderate mental health problems (a score of =1.6 on the 5 single-item POMS questionnaire). Able to read and speak DutchWilling to keep a stable dietary pattern throughout the study, apart from the dietary advice in the studyWilling to not make any changes in birth control medication throughout the study Having a smartphone to fill out the daily questionnaires.Must be able to comply with the study procedures related to the dietary intervention

Exclusion criteria

Exclusion criteria: Having a disease or medical condition or use of medication (such as current use of psychotropic medication) which can influence the study results, to be determined by the medical investigator;Average dietary fiber intake of =18 gram (women) or =22 gram (men) per day (based on the FiberScreen questionnaire);Having a Body Mass Index (BMI) of = 30 kg/m2 (self-reported);People with high anxiety or depression levels, based on the Patient Health Questionnaire for Anxiety and Depression (PHQ-4) questionnaire (total score on 4 items of score =9);Currently following a strict diet and unwilling or unable to changeSpecific food allergies that interfere with dietary intervention (bee products)Use of prebiotics, probiotics and/or synbiotics, B2 vitamins, poly unsaturated fatty acids (PUFAs), fiber supplements or other supplements that could interfere with our outcomes (these should be stopped 4 weeks before the start of the study and remain discontinued until week 8). Use of antibiotic treatment less than 3 months before start of the study Alcoholic use of =14 (women) or =21 (men) glasses of alcoholic beverages per week;Use of soft or hard drugs (should be stopped at least 4 weeks before start of the study); Being pregnant or lactating;Participation in another clinical trial at the same time;Working at Food Health and Consumer Research group of Wageningen Food and Biobased Research, Microbiology at Vrije Unversiteit (VU), the MDL fund, MyMicroZoo, Keep Food Simple, Gezondeboel, GlycanAge, Horaizon, the international Probiotics Association, Anibiome, the Akkermansia company, DSM, or at Medex.

Design outcomes

Primary

MeasureTime frame
 Total mood disturbance (TMD), based on the 32-item POMS questionnaire 

Secondary

MeasureTime frame
Metagenomics, sleep quality, stress, anxiety, depression, glycan profiles, gut transit time and dietary intake 

Countries

Netherlands

Contacts

Public ContactM Belt

Wageningen Universiteit

maartje.vandenbelt@wur.nl0618520632

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 23, 2026