University of East Anglia
Norwich, Norfolk, NR4 7UQ, United Kingdom
NCT Number: NCT05927376
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).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Norwich, Norfolk, NR4 7UQ, United Kingdom
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All foods, meal plans and instructions provided.
All foods, meal plans and instructions provided.
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)
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)
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
Time frame: Postprandial day 1
Measured using MRI
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)
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.
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
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.
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.
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.
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.
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.
Time frame: Upon completion of 5 full days
Assessed through a non-validated single question
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
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
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
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
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
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
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
University of East Anglia
Other
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
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.
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