Skip to main content
OpenTrials
Completed

NCT Number: NCT05927376

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of East Anglia

Norwich, Norfolk, NR4 7UQ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mediterranean Diet

Behavioral

All foods, meal plans and instructions provided.

Western diet

Behavioral

All foods, meal plans and instructions provided.

Primary outcomes

  1. Change in mood

    Time frame: 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)

    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)

  2. Change in anxiety

    Time frame: 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)

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

Secondary outcomes

  1. Change in cognitive performance

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

    Established by a neuropsychological test battery (https://neuropsychology.online) which assesses the following measures; attention, motor function, executive function, episodic memory, impulse control, visuospatial function

  2. Cerebral blood flow

    Time frame: Postprandial day 1

    Measured using MRI

  3. Change in blood pressure

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

    Measurements of brachial artery blood pressure (both diastolic and systolic pressure)

  4. Change in gut microbiota speciation

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

    Faecal samples will be analysed for the gut microflora using 16sRNA sequencing.

  5. Change in plasma short chain fatty acids (SCFA)

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

    Acetate, propionate and butyrate

  6. Change in untargeted metabolomics

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

    Analysed through faecal samples using 1H-NMR-based untargeted metabolomics approach.

  7. Habitual sleep quality profile assessed by the Pittsburgh Sleep Quality Index

    Time frame: Baseline (morning of day 1)

    The Pittsburgh Sleep Quality Index is a 10-items validated questionnaire, which is based on 'the last month'. It will be used to establish usual sleep habits (before the interventions) and to identify sleep disturbances if there is any.

  8. Change in subjective sleep quantity

    Time frame: Each morning, days 1-6

    Assessed using the Karolinska Sleep Diary (KSD). The KSD is a series of questions, with 5 possible tick box options, which characterise the efficiency and the duration of last night's sleep.

  9. Change in subjective sleep quality

    Time frame: Each morning, days 1-6

    Assessed using the Karolinska Sleepiness Scale (KSS). The KSS is a single item, 9-point scale, assessing the sleepiness level at a particular time of day.

  10. Change in objective sleep quality

    Time frame: Each morning, days 1-6

    Assessed using the MotionWatch 8. The MotionWatch 8 is a medical-grade actigraphy watch which can be used to monitor sleep, circadian rhythm and physical activity. Its software (The Motion Ware) will provide two objective measures of sleep quality, namely sleep efficiency and sleep fragmentation.

  11. Participants subjective overview of the intervention

    Time frame: Upon completion of 5 full days

    Assessed through a non-validated single question

Other outcomes

  1. Change in dietary behaviour

    Time frame: Screening and 3 months upon the completion

    Through the Mediterranean Diet Adherence Screener (14 items food questionnaire, MEDAS) questionnaire, with a minimum score of 0 and a maximum of 14. A higher score indicates a higher diet quality which is a better outcome

  2. Change in plasma insulin

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

    Measured using ELISA

  3. Change in plasma glucose

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

    Measured by autoanalyser

  4. Change in plasma triglycerides

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

    Measured by autoanalyser

  5. Change in plasma cortisol

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

    Measured by autoanalyser

  6. Change in plasma brain derived neurotropic factor

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

    Measured by ELISA

  7. Change in plasma serotonin

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

    Measured by ELISA

Sponsors and collaborators

Lead sponsor

University of East Anglia

Other

Collaborators

  • Newcastle University

Registry information

Official study title

MediMood: A Randomised Controlled Trial Investigating the Acute Impact of a Plant Based Mediterranean-style Dietary Pattern (MDP) on Mood, Anxiety and Cognition in UK Adults With Mild to Moderate Mental Health Complaints

Acronym: MediMood

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jul 3, 2023
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.