Clinical Trials Directory

Trials / Completed

CompletedNCT06087471

Snack Foods and Their Impact on Mental Health and the Gut-brain Axis

Snack Foods and Their Impact on the Gut-Brain Axis: a Randomised Controlled Trial on Mental Health and the Gut Microbiota

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
84 (actual)
Sponsor
King's College London · Academic / Other
Sex
All
Age
18 Years – 45 Years
Healthy volunteers
Accepted

Summary

The aim of this study is to investigate the effects of snack foods on mental health and the gut-brain axis, in adults with mild to moderate symptoms of depression and anxiety.

Detailed description

There is increasing evidence on the potential modulating role of healthy dietary patterns in managing symptoms of psychological distress including but not limited to depression and anxiety. Despite growing evidence, further research is required to investigate how dietary interventions may impact symptoms of depression and anxiety, as well as their mechanisms of action via the gut-brain axis. Consumption of snacks now contributes to roughly 17% and 21% of daily energy intake for men and women respectively. Therefore, snacks greatly impact nutritional intake and diet quality and can be a target of dietary manipulation for potential health benefits. This will be the first randomised controlled trial to assess the impact of snack consumption on mental health in adults with mild to moderate symptoms of depression and anxiety. The trial will use a parallel design with a 12-week intervention. Stool and blood samples will be collected at the beginning and end of the intervention for measurement of the gut microbiota and biomarkers related to the gut-brain axis.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTIntervention snackThe intervention snack will be consumed by 42 participants for 12-weeks. Snacks will be consumed twice a day (mid-morning and mid afternoon snack).
DIETARY_SUPPLEMENTControl SnackThe control snack will be consumed by 42 participants for 12-weeks. Snacks will be consumed twice a day (mid-morning and mid afternoon snack).

Timeline

Start date
2023-10-16
Primary completion
2024-05-21
Completion
2024-05-21
First posted
2023-10-17
Last updated
2025-02-18

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT06087471. Inclusion in this directory is not an endorsement.