NCT07442799

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

Efficacy of a Culturally-adapted Mediterranean Diet Intervention on Depression in Relation to the Gut Microbiome: A Randomised Controlled Trial Using the Experience Sampling Methodology

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Depression

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Mediterranean Diet	This group will adhere to the meals (meal delivery, excluding weekends and holidays) prepared by the research team and report their mood and diet quality and adherence using EMA with push notifications four times a day. In addition, photographic food records will also be used to record planned or unplanned meals or snacks. Pre-recorded sessions covering topics such as general dietetic advice, nutrition education on the Mediterranean diet and food components, SMART goal setting will be provided to the participants before the initiation of the MediDiet intervention. Moreover, a brief weekly phone call will be conducted to assess participant adherence, provide encouragement, and address any issues or challenges that may arise.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-02-28
• Completion: 2027-06-30
• First posted: 2026-03-02
• Last updated: 2026-03-03

Locations

1 site across 1 country: Hong Kong