Clinical trial NCT05927376: Mediterranean-style Dietary Pattern (MDP), Mood and Anxiety
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Anxiety
Lead sponsor: University of East Anglia
Sponsor class: OTHER
Collaborators: name: Newcastle University
First posted: 2023-07-03
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Change in mood
timeFrame: 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)
measure: Change in anxiety
timeFrame: 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:
measure: Change in cognitive performance
timeFrame: Baseline (morning of day 1), Postprandial (after lunch on day 1), day 5 (morning of day 6 upon completion of 5 full days intervention)
measure: Cerebral blood flow
timeFrame: Postprandial day 1
measure: Change in blood pressure
timeFrame: Baseline (morning of day 1), Postprandial (after lunch on day 1), day 5 (morning of day 6 upon completion of 5 full days intervention)
measure: Change in gut microbiota speciation
timeFrame: Baseline (morning of day 1), day 5 (morning of day 6 upon completion of 5 full days intervention)
measure: Change in plasma short chain fatty acids (SCFA)
timeFrame: Baseline (morning of day 1), Postprandial (after lunch on day 1), day 5 (morning of day 6 upon completion of 5 full days intervention)
measure: Change in untargeted metabolomics
timeFrame: Baseline (morning of day 1), Postprandial (after lunch on day 1), day 5 (morning of day 6 upon completion of 5 full days intervention)
measure: Habitual sleep quality profile assessed by the Pittsburgh Sleep Quality Index
timeFrame: Baseline (morning of day 1)
measure: Change in subjective sleep quantity
timeFrame: Each morning, days 1-6
measure: Change in subjective sleep quality
timeFrame: Each morning, days 1-6
measure: Change in objective sleep quality
timeFrame: Each morning, days 1-6
measure: Participants subjective overview of the intervention
timeFrame: Upon completion of 5 full days
Other outcomes:
measure: Change in dietary behaviour
timeFrame: Screening and 3 months upon the completion
measure: Change in plasma insulin
timeFrame: Baseline (morning of day 1), Postprandial (after lunch on day 1), day 5 (morning of day 6 upon completion of 5 full days intervention)
measure: Change in plasma glucose
timeFrame: Baseline (morning of day 1), Postprandial (after lunch on day 1), day 5 (morning of day 6 upon completion of 5 full days intervention)
measure: Change in plasma triglycerides
timeFrame: Baseline (morning of day 1), Postprandial (after lunch on day 1), day 5 (morning of day 6 upon completion of 5 full days intervention)
measure: Change in plasma cortisol
timeFrame: Baseline (morning of day 1), Postprandial (after lunch on day 1), day 5 (morning of day 6 upon completion of 5 full days intervention)
measure: Change in plasma brain derived neurotropic factor
timeFrame: Baseline (morning of day 1), Postprandial (after lunch on day 1), day 5 (morning of day 6 upon completion of 5 full days intervention)
measure: Change in plasma serotonin
timeFrame: Baseline (morning of day 1), Postprandial (after lunch on day 1), day 5 (morning of day 6 upon completion of 5 full days intervention)
Locations:
city: Norwich
country: United Kingdom
facility: University of East Anglia
state: Norfolk
Study officials:
affiliation: University of East Anglia
name: Anne Marie Minihane
role: PRINCIPAL_INVESTIGATOR
References: