Depression, AnxietyMediMoodNCT05927376
Mediterranean-style Dietary Pattern (MDP), Mood and Anxiety
A study testing Mediterranean diet and Western diet in people with Depression, Anxiety, run by University of East Anglia at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Mediterranean diet and Western diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of East Anglia
Norwich, Norfolk, NR4 7UQ
About this study
Official 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
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).
Read the 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
- Being tested
- Mediterranean diet, Western diet
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean dietBehavioural
All foods, meal plans and instructions provided.
Western dietBehavioural
All foods, meal plans and instructions provided.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean-style dietary pattern | Experimental | A Mediterranean-style diet (as a whole diet, no supplements) Receives: Behavioral: Mediterranean diet |
| Western-style dietary pattern | Active comparator | A Western-style diet (as a whole diet, no supplements) Receives: Behavioral: Western diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
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
Measured: 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
Measured using MRI
Measured: Postprandial day 1
Change in blood pressure
Measurements of brachial artery blood pressure (both diastolic and systolic pressure)
Measured: 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
Faecal samples will be analysed for the gut microflora using 16sRNA sequencing.
Measured: 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)
Acetate, propionate and butyrate
Measured: 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 untargeted metabolomics
Analysed through faecal samples using 1H-NMR-based untargeted metabolomics approach.
Measured: Baseline (morning of day 1), Postprandial (after lunch on day 1), day 5 (morning of day 6 upon completion of 5 full days intervention)
Habitual sleep quality profile assessed by the Pittsburgh Sleep Quality Index
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.
Measured: Baseline (morning of day 1)
Change in subjective sleep quantity
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.
Measured: Each morning, days 1-6
Change in subjective sleep quality
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.
Measured: Each morning, days 1-6
Change in objective sleep quality
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.
Measured: Each morning, days 1-6
Participants subjective overview of the intervention
Assessed through a non-validated single question
Measured: Upon completion of 5 full days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Aug 2023
- Primary completion15 Dec 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Collaborators
- Newcastle University
- Responsible party
- Sponsor
- Investigators
- Anne Marie Minihane, Principal investigator, University of East Anglia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927376
- Sponsor's protocol ID
- R211670
- Acronym
- MediMood
- Status last verified
- May 2024
- First submitted
- 2 Mar 2023
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39806712
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05927376
- Acronym / sponsor ID
- MediMood / R211670
- Conditions
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Collaborators
- Newcastle University
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mediterranean-style dietary pattern | Experimental | Behavioral: Mediterranean dietA Mediterranean-style diet (as a whole diet, no supplements) |
| Western-style dietary pattern | Active comparator | Behavioral: Western dietA Western-style diet (as a whole diet, no supplements) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediterranean dietAll foods, meal plans and instructions provided. | Behavioural | Mediterranean-style dietary pattern |
| Western dietAll foods, meal plans and instructions provided. | Behavioural | Western-style dietary pattern |
Primary outcome
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)
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)
11 secondary outcomes
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)
Cerebral blood flow
Time frame: Postprandial day 1
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)
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)
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)
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)
Habitual sleep quality profile assessed by the Pittsburgh Sleep Quality Index
Time frame: Baseline (morning of day 1)
Change in subjective sleep quantity
Time frame: Each morning, days 1-6
Change in subjective sleep quality
Time frame: Each morning, days 1-6
Change in objective sleep quality
Time frame: Each morning, days 1-6
Participants subjective overview of the intervention
Time frame: Upon completion of 5 full days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Derived from this study: PubMed 39806712Esgunoglu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Marie Minihane principal investigator
University of East Anglia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean diet and Western diet in people with Depression, Anxiety, run by University of East Anglia at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05927376, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.