Randomised controlled trial of the effects of kefir on behaviour, sleep and the microbiome in children with ADHD: a study protocol.

INTRODUCTION: Current interventions for children with attention-deficit/hyperactivity disorder (ADHD) are primarily medication, behavioural therapy and parent training. However, research suggests dietary manipulations may provide therapeutic benefit for some. There is accumulating evidence that the gut microbiome may be atypical in ADHD, and therefore, manipulating gut bacteria in such individuals may help alleviate some of the symptoms of this condition. The aim of this study is to explore the effects of supplementation with kefir (a fermented dairy drink) on ADHD symptomatology, sleep, attention and the gut microbiome in children diagnosed with ADHD. METHODS AND ANALYSIS: A 6-week randomised, double-blind, placebo-controlled trial in 70 children aged 8-13 years diagnosed with ADHD. Participants will be recruited throughout the UK, through support groups, community groups, schools, social media and word of mouth. Children will be randomised to consume daily either dairy kefir or a placebo dairy drink for 6 weeks. The primary outcome, ADHD symptomatology, will be measured by The Strengths and Weakness of ADHD-symptoms and Normal-behaviour scale. Secondary outcomes will include gut microbiota composition (using shotgun metagenomic microbiome sequencing), gut symptomatology (The Gastrointestinal Severity Index questionnaire), sleep (using 7-day actigraphy recordings, The Child's Sleep Habits Questionnaire and Sleep Self Report questionnaire), inattention and impulsivity (with a computerised Go/NoGo test). Assessments will be conducted prior to the intervention and at the end of the intervention. Interaction between time (preintervention/postintervention) and group (probiotic/placebo) is to be analysed using a Mixed Model Analysis of Variances. ETHICS AND DISSEMINATION: Ethical approval for the study was granted by St Mary's University Ethics Committee. Results will be disseminated through peer-reviewed publications, presentations to the scientific community and support groups. TRIAL REGISTRATION NUMBER: NCT05155696.

Public beliefs and willingness to accept COVID-19 vaccines among adults in South-Western Nigeria: A cross-sectional study.

Background: Despite the government's and development partners' unmatched efforts to ensure that every eligible person receives vaccinations, there have been concerns about vaccine fear, government mistrust, vaccine hesitancy and rejection expressed by the public, as well as various conspiracy theories involving the COVID-19 vaccines. This study assessed the public beliefs and willingness to accept COVID-19 vaccines and related factors among residents of Ondo State, Nigeria. Methods: Using a convenience sample technique, a cross-sectional survey of the adult population was carried out in the months of February and March of 2022. Factors influencing beliefs and willingness to accept COVID-19 vaccines were found by using univariate and multivariate statistical analysis. Results: 306 out of 323 respondents completed the survey and were included in the final analysis. The respondents mean age was 28.16 ± 16.2 years. Although n = 223, 72.9% of respondents reported to have received at least one dose of COVID-19 vaccines, (n = 205) 67.0% believed COVID-19 vaccines to be effective. Among the individuals who had not yet had any COVID-19 vaccinations, 2.6% (n = 8) of respondents were willing to accept the vaccines, whereas 14.1% (n = 43) were unwilling. Respondents' beliefs about the efficacy of COVID-19 vaccines were influenced by their gender, occupation, religion and educational attainment (p < 0.005). Conclusion: The study revealed a good level of positive beliefs about the vaccine, which was mirrored in vaccination history. However, those who had not yet received the vaccine were unwilling to do so, opening the door for more aggressive risk communication to be able to alter the course of events. In addition to addressing additional COVID-19 vaccination myths, we advise policy-makers to develop communication strategies that emphasise the safety of the COVID-19 vaccine. It is advised that all relevant stakeholders be included in government COVID-19 vaccination programmes by sharing timely, transparent information that fosters accountability.

Trialling a microbiome-targeted dietary intervention in children with ADHD-the rationale and a non-randomised feasibility study.

BACKGROUND: Dietary interventions have been previously explored in children with ADHD. Elimination diets and supplementation can produce beneficial behaviour changes, but little is known about the mechanisms mediating change. We propose that these interventions may work, in part, by causing changes in the gut microbiota. A microbiome-targeted dietary intervention was developed, and its feasibility assessed. METHODS: A non-randomised feasibility study was conducted on nine non-medicated children with ADHD, aged 8-13 years (mean 10.39 years), using a prospective one-group pre-test/post-test design. Participants were recruited from ADHD support groups in London and took part in the 6-week microbiome-targeted dietary intervention, which was specifically designed to impact the composition of gut bacteria. Children were assessed pre- and post-intervention on measures of ADHD symptomatology, cognition, sleep, gut function and stool-sample microbiome analysis. The primary aim was to assess the study completion rate, with secondary aims assessing adherence, adverse events (aiming for no severe and minimal), acceptability and suitability of outcome measures. RESULTS: Recruitment proved to be challenging and despite targeting 230 participants directly through support groups, and many more through social media, nine families (of the planned 10) signed up for the trial. The completion rate for the study was excellent at 100%. Exploration of secondary aims revealed that (1) adherence to each aspect of the dietary protocol was very good; (2) two mild adverse events were reported; (3) parents rated the treatment as having good acceptability; (4) data collection and outcome measures were broadly feasible for use in an RCT with a few suggestions recommended; (5) descriptive data for outcome measures is presented and suggests that further exploration of gut microbiota, ADHD symptoms and sleep would be helpful in future research. CONCLUSIONS: This study provides preliminary evidence for the feasibility of a microbiome-targeted dietary intervention in children with ADHD. Recruitment was challenging, but the diet itself was well-tolerated and adherence was very good. Families wishing to trial this diet may find it an acceptable intervention. However, recruitment, even for this small pilot study, was challenging. Because of the difficulty experienced recruiting participants, future randomised controlled trials may wish to adopt a simpler dietary approach which requires less parental time and engagement, in order to recruit the number of participants required to make meaningful statistical interpretations of efficacy. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03737877 . Registered 13 November 2018-retrospectively registered, within 2 days of the first participant being recruited.

Medical encounters at community-based physical activity events (parkrun) in the UK.

OBJECTIVE: To determine the incidence, clinical correlates and exposure risk of medical encounters during community-based physical activity events in the UK. METHODS: An analysis of medical data from weekly, community-based physical activity events (parkrun) at 702 UK locations over a 6-year period (29 476 294 participations between 2014 and 2019) was conducted in order to define the incidence and clinical correlates of serious life-threatening, non-life-threatening and fatal medical encounters. RESULTS: 84 serious life-threatening encounters (overall incidence rate=0.26/100 000 participations) occurred including 18 fatalities (0.056/100 000 participations). Statistical modelling revealed that the probabilities of serious life-threatening encounters were exceptionally low, however, male sex, increasing age, slower personal best parkrun time and less prior running engagement/experience (average number of runs per year and number of years as a parkrun participant) were associated with increased probability of serious life-threatening encounters. These were largely accounted for by cardiac arrest (48/84, 57%) and acute coronary syndromes (20/84, 24%). Non-life-threatening medical encounters were mainly attributed to tripping or falling, with a reported incidence of 39.2/100 000 participations. CONCLUSIONS: Serious life-threatening and fatal medical encounters associated with parkrun participation are extremely rare. In the context of a global public health crisis due to inactivity, this finding underscores the safety and corollary public health value of community running/walking events as a strategy to promote physical activity.

Concord grape juice, cognitive function, and driving performance: a 12-wk, placebo-controlled, randomized crossover trial in mothers of preteen children.

BACKGROUND: Daily consumption of Concord grape juice (CGJ) over 3-4 mo has been shown to improve memory function in adults with mild cognitive impairment and reduce blood pressure in hypertensive adults. These benefits likely result from the high concentration of polyphenols in CGJ. Increased stress can impair cognitive function and elevate blood pressure. Thus, we examined the potential beneficial effect of CGJ in individuals with somewhat stressful and demanding lifestyles. OBJECTIVE: We sought to examine the effects of the daily consumption of CGJ for 12 wk on cognitive function, driving performance, and blood pressure in healthy, middle-aged working mothers. DESIGN: Twenty-five healthy mothers (aged 40-50 y) of preteen children who were employed for ≥30 h/wk consumed 12 ounces (355 mL) of either CGJ (containing 777 mg total polyphenols) or an energy-, taste-, and appearance-matched placebo daily for 12 wk according to a randomized crossover design with a 4-wk washout. Verbal and spatial memory, executive function, attention, blood pressure, and mood were assessed at baseline and at 6 and 12 wk. Immediately after the cognitive battery, a subsample of 17 women completed a driving performance assessment at the University of Leeds Driving Simulator. The 25-min driving task required participants to match the speed and direction of a lead vehicle. RESULTS: Significant improvements in immediate spatial memory and driving performance were observed after CGJ relative to placebo. There was evidence of an enduring effect of CGJ such that participants who received CGJ in arm 1 maintained better performance in the placebo arm. CONCLUSIONS: Cognitive benefits associated with the long-term consumption of flavonoid-rich grape juice are not exclusive to adults with mild cognitive impairment. Moreover, these cognitive benefits are apparent in complex everyday tasks such as driving. Effects may persist beyond the cessation of flavonoid consumption, and future studies should carefully consider the length of washout within crossover designs. This trial was registered at clinicaltrials.gov as NCT01411631.

Dietary intake of 20 polyphenol subclasses in a cohort of UK women.

BACKGROUND: Establishing and linking the proposed health benefits of dietary polyphenols to their consumption requires measurement of polyphenol intake in appropriate samples and an understanding of factors that influence their intake in the general population. METHODS: This study examined polyphenol intake estimated from 3- and 7-day food diaries in a sample of 246 UK women aged 18-50 years. Estimation of the intake of 20 polyphenol subclasses commonly present in foods consumed by the sample studied was done using Phenol-Explorer(®) and USDA polyphenol databases. Women were participants in the Leeds Women's Wellbeing Study (LWW) (n = 143), a dietary intervention study aimed at overweight women (mean age 37.2 ± 9.4 years; mean BMI 30.8 ± 3.1 kg/m(2)), and the Diet and Health Study (DH) (n = 103) which aimed to examine the relationship between polyphenol intake and cognitive function (mean age 25.0 ± 9.0 years; mean BMI 24.5 ± 4.6 kg/m(2)). RESULTS: The estimated intake of polyphenol subclasses was significantly different between the two samples (p < 0.01) with consumption of 1292 ± 844 and 808 ± 680 mg/day for the LWW and DH groups, respectively. Flavanols and hydroxycinnamic acids were the most important contributors to the polyphenols consumed by both groups, owing to tea and coffee consumption. Other major polyphenol food sources included fruits, vegetables and processed foods. CONCLUSION: Older women consumed more polyphenol-containing foods and beverages, which was due to the higher coffee and tea consumption amongst the LWW participants.