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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in anxiety
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Change in anxiety
时间窗: 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)
Change in mood
时间窗: 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)
次要结局
- 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))
- Change in untargeted metabolomics(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(Baseline (morning of day 1))
- Change in subjective sleep quantity(Each morning, days 1-6)
- Change in subjective sleep quality(Each morning, days 1-6)
- Change in objective sleep quality(Each morning, days 1-6)
- Participants subjective overview of the intervention(Upon completion of 5 full days)