NCT07442799

Efficacy of a Culturally-adapted Mediterranean Diet Intervention on Depression in Relation to the Gut Microbiome

Not yet recruiting NA Last updated 3 March 2026

What this trial tests

NA trial testing Mediterranean Diet in Depression in 90 participants. Not yet recruiting.

Timeline

1 March 2026

Primary endpoint
28 February 2027

30 June 2027

Quick facts

Lead sponsor	Chinese University of Hong Kong
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	90
Start date	1 March 2026
Primary completion	28 February 2027
Estimated completion	30 June 2027
Sites	1 location across Hong Kong

Drugs / interventions tested

• Mediterranean Diet

Conditions studied

• Depression — all drugs for Depression →

Sponsor

Chinese University of Hong Kong

Who can join

Adults 18 to 65, any sex, with Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of this study is to investigate the efficacy of a culturally-adapted Mediterranean diet, in accordance with clinical guidelines and research evidence, in reducing depressive symptoms among Hong Kong Chinese adults. Additionally, this study will also explore the potential underlying role of the gut microbiome in the relationship between the Mediterranean diet and depression. This study serves as a pioneering attempt to examine the efficacy and intervention acceptability of a culturally-adapted Mediterranean diet in managing depressive symptoms.

Several studies have demonstrated the relationship between diet and mood, while existing studies suggest that consistently adhering to the Mediterranean diet may yield a more pronounced antidepressant effect. Considering that depression is often associated with low motivation, dietary interventions that require active participation may encounter implementation challenges and potentially impact the adherence rate. To address this issue, our study proposes using ecological momentary assessment (EMA), which involves sending frequent reminders to participants, allowing us to examine diet quality and adherence as well as changes in depressive symptoms at various time points. This approach also minimizes potential recall bias and enhances data collection accuracy. If the hypothesis is supported, dietary intervention could emerge as a promising therapeutic strategy for alleviating depressive symptoms. Furthermore, this study could provide insights into the role of the gut microbiome as a potential underlying mechanism between diet and depressive symptoms. The findings could have significant implications for clinical practice.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.