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

NCT05927376 | Completed

• 1 other identifier: R211670
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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).

Conditions

Depression, Anxiety

Outcome Measures

Primary Outcomes (2)

• Change in mood

  Established by the Bond-Lader visual analogue scale (includes 16 items each having antonyms on two ends, on a scale of 1 to 100, 50 being the neutral point)

  Baseline (morning of day 1), Postprandial (after lunch on Established by the Bond-Lader visual analogue scale (includes 16 items each having day 1), 24-hours (morning of day 2), day 5 (morning of day 6 upon completion of 5 full days intervention)

• Change in anxiety

  Established by the Profile of Mood States (includes 65 items on a 5 point Likert scale)

  Baseline (morning of day 1), Postprandial (after lunch on day 1), 24-hours (morning of day 2), day 5 (morning of day 6 upon completion of 5 full days intervention)

Secondary Outcomes (11)

• Change in cognitive performance

  Baseline (morning of day 1), Postprandial (after lunch on day 1), day 5 (morning of day 6 upon completion of 5 full days intervention)

• Cerebral blood flow

  Postprandial day 1

• Change in blood pressure

  Baseline (morning of day 1), Postprandial (after lunch on day 1), day 5 (morning of day 6 upon completion of 5 full days intervention)

• Change in gut microbiota speciation

  Baseline (morning of day 1), day 5 (morning of day 6 upon completion of 5 full days intervention)

• Change in plasma short chain fatty acids (SCFA)

  Baseline (morning of day 1), Postprandial (after lunch on day 1), day 5 (morning of day 6 upon completion of 5 full days intervention)

Other Outcomes (7)

• Change in dietary behaviour

  Screening and 3 months upon the completion

• Change in plasma insulin

  Baseline (morning of day 1), Postprandial (after lunch on day 1), day 5 (morning of day 6 upon completion of 5 full days intervention)

• Change in plasma glucose

  Baseline (morning of day 1), Postprandial (after lunch on day 1), day 5 (morning of day 6 upon completion of 5 full days intervention)

Study Arms (2)

Mediterranean-style dietary pattern

EXPERIMENTAL

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

Behavioral: Mediterranean diet

Western-style dietary pattern

ACTIVE COMPARATOR

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

Behavioral: Western diet

Interventions

Mediterranean diet BEHAVIORAL

All foods, meal plans and instructions provided.

Mediterranean-style dietary pattern

Western diet BEHAVIORAL

All foods, meal plans and instructions provided.

Western-style dietary pattern

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of East Anglia: lead
• Newcastle University: collaborator

Study Sites (1)

University of East Anglia

Norwich, Norfolk, NR4 7UQ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39806712 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Diet, Mediterranean; Diet, Western

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Anne Marie Minihane

  University of East Anglia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: July 3, 2023
• Study Start: August 1, 2023
• Primary Completion: December 15, 2023
• Study Completion: June 30, 2024
• Last Updated: April 3, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)