Mediterranean-style Dietary Pattern (MDP), Mood and Anxiety

NCT ID: NCT05927376

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-06-30

Brief Summary

Observational studies and a limited numbers of RCTs have observed that habitual Mediterranean-style dietary pattern (MDP) consumption is associated with improved mental health and cognition. Yet, its efficacy in a short-term has not been studied in well-controlled intervention settings.

MediMood is a cross-over RCT aiming to test whether a MDP can affect mood and anxiety following a meal (postprandial) and over 5-days in adults over 18 years with mild to moderate mental health problems relative to a Western diet (WD).

Detailed Description

Depression, anxiety and age-related cognitive decline are leading global public health problems. A plant-based Mediterranean-style dietary pattern (MDP) includes olive oil as the main source of fat, fresh fruits, vegetables, seafood, legumes and nuts and a low consumption of red and processed meat, confectionary, and high-sugar drinks. A MDP promotes both physical and mental wellbeing and brain function. However, most studies to date have examined the impact of a MDP on health over months or years. As several underpinning biological mechanisms are likely to be responsive within hours or days, examining the short-term effect of a MDP on mental health outcomes is important. The overall goal of the present study is to understand the effects of a MDP on acute/sub-chronic brain health and its underpinning mechanisms.

MediMood is a randomised cross-over efficacy trial. Participants will be assigned to an isocaloric MDP and a Western diet (WD) for 5-days in a random order with a 4-week wash-out period. All foods, meal plans and detailed dietary instructions will be provided. In addition to the primary outcome measures (mood and anxiety), the impact of intervention on cognitive performance, sleep, cerebral blood flow (MRI) and a selection of biomarkers of brain function will be measured in biological samples over five days.

As low mood, anxiety and stress disorders affect daily functioning and reduce the quality of life significantly for many, the investigators believe the findings will have wide public health application.

Conditions

Depression, Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Mediterranean-style dietary pattern

A Mediterranean-style diet (as a whole diet, no supplements)

Group Type: EXPERIMENTAL

Mediterranean diet

Intervention Type: BEHAVIORAL

All foods, meal plans and instructions provided.

Western-style dietary pattern

A Western-style diet (as a whole diet, no supplements)

Group Type: ACTIVE_COMPARATOR

Western diet

Intervention Type: BEHAVIORAL

All foods, meal plans and instructions provided.

Interventions

Mediterranean diet

All foods, meal plans and instructions provided.

Intervention Type: BEHAVIORAL

Western diet

All foods, meal plans and instructions provided.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Male and female, aged 18 or above
• Is willing and able to comply with all study procedures, including changes in diets
• Has access to and able to use the internet/computer/tablet device
• Mild to moderate level of anxiety and/or depression symptoms, assessed by Generalised Anxiety disorder (GAD-7) score and Patient Health Questionnaire (PHQ-9), scores 5 to 14 on both questionnaires
• A habitual MEDAS score of ≤ 7/14
• To be fluent in English

Exclusion Criteria

• MEDAS score >7
• Vegan/vegetarian
• Allergies to one of the study components i.e. nuts, fish
• On antidepressant or antianxiety medication where dosage is likely to change over the next 3 month
• Factors precluding MRI scanning such as suffers from claustrophobia or has metal implants
• Not fluent in English
• Not agreement for the study team to contact the participants general practitioner about trial participation and screening results
• Not prepared to make changes to the diet for 10 days (2 x 5 day periods)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Newcastle University

OTHER

Sponsor Role: collaborator

University of East Anglia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne Marie Minihane

Role: PRINCIPAL_INVESTIGATOR

University of East Anglia

Locations

University of East Anglia

Norwich, Norfolk, United Kingdom

Countries

United Kingdom

References

Esgunoglu L, Liaquat M, Gillings R, Lazar A, Leddy A, Brooks J, Penny W, Sami S, Hornberger M, Stevenson E, Jennings A, Minihane AM. Acute effect of a Mediterranean-style dietary pattern (MDP) on mood, anxiety and cognition in UK adults with mild to moderate anxiety and depression: the MediMood randomised controlled trial protocol. BMJ Open. 2024 Dec 20;14(12):e082935. doi: 10.1136/bmjopen-2023-082935.

Reference Type: DERIVED

PMID: 39806712 (View on PubMed)

Other Identifiers

R211670

Identifier Type: -

Identifier Source: org_study_id