scholarly journals Effect of a Mediterranean diet intervention on gastrointestinal function in Parkinson’s disease (the MEDI-PD study): study protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e053336
Author(s):  
Carley Rusch ◽  
Matthew Beke ◽  
Lily Tucciarone ◽  
Katherine Dixon ◽  
Carmelo Nieves Jr. ◽  
...  

IntroductionConstipation is a common and sometimes debilitating non-motor symptom of Parkinson’s disease (PD) that can result in intestinal inflammation and microbial dysbiosis. The Mediterranean diet, rich in fermentable fibres and anti-inflammatory phenolic compounds, is associated with reduced risk of developing PD and slower progression of parkinsonism. The Mediterranean diet is often recommended for people with PD; however, no studies to date examine this diet as a therapeutic intervention to modulate gastrointestinal (GI) dysfunction.Methods and analysisThis is a randomised, controlled, parallel study. During a 2-week run-in, participants with PD and constipation symptoms (n=52) will undergo baseline nutritional and neurological assessments and provide a stool sample. Participants will be stratified by sex and Hoehn and Yahr stage and randomised to follow standard of care for constipation (control) or standard of care plus a Mediterranean diet (intervention) for 8 weeks. A study dietitian will provide dietary instruction and weekly follow-up via telephone to both groups to support adherence and monitor adverse events. Questionnaires will assess dietary intake and GI function including stool frequency, form, symptoms and laxative usage. Measurements completed at baseline will be repeated at 4 and 8 weeks of the intervention. The primary outcome is to evaluate the difference between mean change (final–baseline) in Gastrointestinal Symptom Rating Scale (GSRS) constipation syndrome scores for the control versus intervention groups. Secondary outcomes will assess stool frequency and form, weekly GSRS syndrome scores, digestive quality of life, laxative usage, faecal microbial communities and inflammatory markers, anxiety, depression, quality life, body weight and composition, dietary fibre intake and Mediterranean diet adherence.Ethics and disseminationThe study has received University of Florida Institutional Review Board-01 approval (IRB202001333). Findings will be disseminated via conference presentations, lectures and peer-reviewed publications.Trial registration numberNCT04683900.

2021 ◽  
Author(s):  
Joshua Niklas Strelow ◽  
Carlos Baldermann ◽  
Till A Dembek ◽  
Hannah Jergas ◽  
Jan Niklas Petry-Schmelzer ◽  
...  

Gait impairments such as freezing of gait (FOG) are among the most common and disabling symptoms of Parkinson's disease (PD). While the efficacy of deep brain stimulation (DBS) of the subthalamic nucleus (STN) in patients with early or advanced PD has been proven in large randomised controlled trials, its effect on gait impairments is still insufficiently understood. Moreover, there is uncertainty about pathways that need to be modulated to improve gait impairments. In this bi-centric study, we investigated how STN-DBS alters FOG in 47 subjects with PD. We assessed freezing prevalence and severity using the Freezing of Gait Questionnaire and Item 14 of the Unified Parkinson's Disease Rating Scale-II. Using a model of publicly available basal-ganglia pathways we determined a connectivity profile for postoperative changes in FOG. Compared to preoperative baseline, freezing of gait significantly improved six months postoperatively, marked by reduced frequency and duration of freezing episodes. We found that optimal stimulation sites for improving freezing of gait structurally connected to primary and supplementary motor areas, the dorsolateral prefrontal cortex and to the globus pallidus. Stimulation of the lenticular fasciculus was associated with worsening of freezing of gait. Our findings highlight the need for optimal identification and characterisation for network structures that can be implemented in stereotactic planning and can additionally pose a target for postoperative stimulation strategies.


Nutrients ◽  
2021 ◽  
Vol 13 (11) ◽  
pp. 3970
Author(s):  
Anne J. Strikwerda ◽  
Lisanne J. Dommershuijsen ◽  
M. Kamran Ikram ◽  
Trudy Voortman

The Mediterranean diet has been associated with the risk of Parkinson’s disease (PD), but limited research has been performed on other dietary patterns. We studied the relationship between overall diet quality and PD risk in the general population. We included 9414 participants from the Rotterdam Study, a prospective population-based study in the Netherlands. Diet was defined using a Dutch diet quality score, a Mediterranean diet score and data-driven dietary patterns constructed with principal component analysis (PCA). During an average follow-up of 14.1 years, PD was diagnosed in 129 participants. We identified a ‘Prudent’, ‘Unhealthy’ and ‘Traditional Dutch’ pattern from the PCA. We found a possible association between the Mediterranean diet (Hazard ratio (HR) per standard deviation (SD) 0.89 (95% confidence interval (CI) 0.74–1.07)), the ‘Prudent’ pattern (HR per SD 0.81 (95% CI 0.61–1.08)) and the risk of PD. However, no associations with PD risk were found for the Dutch diet quality score (HR per SD 0.93 (95% CI 0.77–1.12)), the ‘Unhealthy’ pattern (HR per SD 1.05 (95% CI 0.85–1.29)) or the ‘Traditional Dutch’ pattern (HR per SD 0.90 (95% CI 0.69–1.17)). In conclusion, our results corroborate previous findings of a possible protective effect of the Mediterranean diet. Further research is warranted to study the effect of other dietary patterns on PD risk.


2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 1742-1742
Author(s):  
Carley Rusch ◽  
Matthew Beke ◽  
Carmelo Nieves ◽  
Maria Ukhanova ◽  
Volker Mai ◽  
...  

Abstract Objectives Constipation is a common and debilitating nonmotor symptom of Parkinson's disease (PD) that is poorly understood and has limited treatment options. A preliminary pilot study conducted at our center suggests that a Mediterranean diet, which emphasizes foods rich in fermentable fibers and antioxidants, can reduce symptoms of constipation in patients with PD, but may also result in unintended reductions in body weight. This may potentially attenuate  the benefit of this dietary intervention. The primary outcome of this project is to test the efficacy of a Mediterranean diet intervention on improving the clinical symptoms of constipation in PD. Secondary outcomes will determine the effect of this intervention on body composition, fecal microbial communities and markers of intestinal inflammation and permeability. Methods This is a 10-week, randomized, controlled, parallel study. Participants with PD (diagnosed by a movement disorder neurologist) who have symptoms of constipation and do not follow a Mediterranean diet will be recruited (n = 42). During the 2-week run-in period, participants will undergo neurological, nutritional, and body composition assessments. Urine and stool samples to assess intestinal permeability (urine sugar probe test), inflammation and microbial communities will be collected. Participants will then be randomized to follow the Mediterranean diet or to maintain their habitual diet for 8 weeks. A study dietitian will provide in-person dietary instruction and weekly follow-up via telephone to both groups to support diet adherence and monitor changes in weight and adverse events. Throughout the study, questionnaires will assess dietary intake and gastrointestinal function including laxative usage. Measurements completed at baseline will be repeated at 4 and 8 weeks of the intervention. Results N/A Conclusions We hypothesize that a Mediterranean diet intervention administered by a registered dietitian/nutritionist will result in dietary changes that improve constipation symptoms, reduce intestinal permeability and inflammation, and favor beneficial microbial communities without producing unintended effects on body mass. Funding Sources University of Florida Moonshot Initiative.


2021 ◽  
Vol 12 ◽  
Author(s):  
Carley Rusch ◽  
Matthew Beke ◽  
Lily Tucciarone ◽  
Carmelo Nieves ◽  
Maria Ukhanova ◽  
...  

Introduction: Non-motor symptoms of Parkinson's disease (PD) such as gastrointestinal (GI) dysfunction are common, yet little is known about how modifying dietary intake impacts PD symptoms. The aim of this study in individuals with PD was to determine whether a Mediterranean diet intervention is feasible and affects GI function, intestinal permeability and fecal microbial communities.Methods: A single-arm, 5-week Mediterranean diet intervention study was conducted in eight people with PD. Daily and weekly questionnaires were administered to determine changes in GI symptoms. Urine and stool samples were collected at baseline and after 5 weeks to assess intestinal permeability and fecal microbial communities. Additionally, live-in partners of the participants with PD were matched as controls (n = 8) for baseline urine and stool samples.Results: Participants with PD increased intake of Mediterranean diet based on adherence scores from baseline to week 5 (4.4 ± 0.6 vs. 11.9 ± 0.7; P < 0.01 with >10 representing good adherence), which was linked with weight loss (77.4 kg vs. 74.9 kg, P = 0.01). Constipation syndrome scores decreased after 5 weeks (2.3 ± 0.5 vs. 1.5 ± 0.3; P = 0.04). Bilophila, was higher at baseline in PD (0.6 ± 0.1% vs. 0.2 ± 0.1% P = 0.02) and slightly decreased after the diet intervention (0.5 ± 0.1%; P = 0.01). Interestingly, the proportion of Roseburia was significantly lower in PD compared to controls (0.6 ± 0.2% vs. 1.6 ± 0.3%; P = 0.02) and increased at week 5 (0.9 ± 0.2%; P < 0.01). No differences were observed for markers of intestinal permeability between the control and PD groups or post-intervention.Conclusions: Short-term Mediterranean diet adherence is feasible in participants with PD; correlated with weight loss, improved constipation, and modified gut microbiota.Clinical Trial Registration:ClinicalTrials.gov, identifier: NCT03851861.


2017 ◽  
Vol 35 (6) ◽  
pp. 404-412 ◽  
Author(s):  
Hongjie Liu ◽  
Lingxiu Chen ◽  
Zhe Zhang ◽  
Guozhu Geng ◽  
Wenjun Chen ◽  
...  

Objective To evaluate the effectiveness and safety of acupuncture combined with Madopar for the treatment of Parkinson's disease (PD), compared to the use of Madopar alone. Methods A systematic search was carried out for randomised controlled trials (RCTs) of acupuncture and Madopar for the treatment of PD published between April 1995 and April 2015. The primary outcome was total effectiveness rate and secondary outcomes included Unified Parkinson's Disease Rating Scale (UPDRS) scores. Data were pooled and analysed with RevMan 5.3. Results were expressed as relative ratio (RR) with 95% confidence interval (CIs). Results Finally, 11 RCTs with 831 subjects were included. Meta-analyses showed that acupuncture combined with Madopar for the treatment of PD can significantly improve the clinical effectiveness compared with Madopar alone (RR=1.28, 95% CI 1.18 to 1.38, P<0.001). It was also found that acupuncture combined with Madopar significantly improved the UPDRS II (SMD=−1.00, 95% CI −1.71 to −0.29, P=0.006) and UPDRS I–IV total summed scores (SMD=−1.15, 95% CI −1.63 to −0.67, P<0.001) but not UPDRS I (SMD=−0.37, 95% CI −0.77 to 0.02, P=0.06), UPDRS III (SMD=−0.93, 95% CI −2.28 to 0.41, P=0.17) or UPDRS IV (SMD=−0.78, 95% CI −2.24 to 0.68, P=0.30) scores. Accordingly, acupuncture combined with Madopar appeared to have a positive effect on activities of daily life and the general condition of patients with PD, but was not better than Madopar alone for the treatment of mental activity, behaviour, mood and motor disability. In the safety evaluation, it was found that acupuncture combined with Madopar was associated with significantly fewer adverse effects including gastrointestinal reactions (RR=0.38, 95% CI 0.23 to 0.65, P<0.001), on–off phenomena (RR=0.27, 95% CI 0.11 to 0.66, P=0.004) and mental disorders (RR=0.24, 95% CI 0.06 to 0.92, P=0.04) but did not significantly reduce dyskinesia (RR=0.64, 95% CI 0.35 to 1.16, P=0.14). Conclusion Acupuncture combined with Madopar appears, to some extent, to improve clinical effectiveness and safety in the treatment of PD, compared with Madopar alone. This conclusion must be considered cautiously, given the quality of most of the studies included was low. Therefore, more high-quality, multicentre, prospective, RCTs with large sample sizes are needed to further clarify the effect of acupuncture combined with Madopar for PD.


2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Agnes Langer ◽  
Sebastian Hasenauer ◽  
Anna Flotz ◽  
Lucia Gassner ◽  
Rochus Pokan ◽  
...  

AbstractPhysical activity is of prime importance in non-pharmacological Parkinson’s disease (PD) treatment. The current study examines the effectiveness and feasibility of sport climbing in PD patients in a single-centre, randomised controlled, semi-blind trial. A total of 48 PD patients without experience in climbing (average age 64 ± 8 years, Hoehn & Yahr stage 2–3) were assigned either to participate in a 12-week sport climbing course (SC) or to attend an unsupervised physical training group (UT). The primary outcome was the improvement of symptoms on the Movement Disorder Society-Sponsored Revision of the Unified Parkinson’s Disease Rating Scale part III (MDS-UPDRS-III). Sport climbing was associated with a significant reduction of the MDS-UPDRS-III (−12.9 points; 95% CI −15.9 to −9.8), while no significant improvement was to be found in the UT (−3.0 points; 95% CI −6.0 to 0.1). Bradykinesia, rigidity and tremor subscales significantly improved in SC, but not in the unsupervised control group. In terms of feasibility, the study showed a 99% adherence of participants to climbing sessions and a drop-out rate of only 8%. No adverse events occurred. This trial provides class III evidence that sport climbing is highly effective and feasible in mildly to moderately affected PD patients.


2012 ◽  
Author(s):  
Jaime Kulisevsky ◽  
Ramón Fernández de Bobadilla ◽  
Javier Pagonabarraga

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e040527
Author(s):  
Julia C Greenland ◽  
Emma Cutting ◽  
Sonakshi Kadyan ◽  
Simon Bond ◽  
Anita Chhabra ◽  
...  

IntroductionThe immune system is implicated in the aetiology and progression of Parkinson’s disease (PD). Inflammation and immune activation occur both in the brain and in the periphery, and a proinflammatory cytokine profile is associated with more rapid clinical progression. Furthermore, the risk of developing PD is related to genetic variation in immune-related genes and reduced by the use of immunosuppressant medication. We are therefore conducting a ‘proof of concept’ trial of azathioprine, an immunosuppressant medication, to investigate whether suppressing the peripheral immune system has a disease-modifying effect in PD.Methods and analysisAZA-PD is a phase II randomised placebo-controlled double-blind trial in early PD. Sixty participants, with clinical markers indicating an elevated risk of disease progression and no inflammatory or immune comorbidity, will be treated (azathioprine:placebo, 1:1) for 12 months, with a further 6-month follow-up. The primary outcome is the change in the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale gait/axial score in the OFF state over the 12-month treatment period. Exploratory outcomes include additional measures of motor and cognitive function, non-motor symptoms and quality of life. In addition, peripheral and central immune markers will be investigated through analysis of blood, cerebrospinal fluid and PK-11195 positron emission tomography imaging.Ethics and disseminationThe study was approved by the London-Westminster research ethics committee (reference 19/LO/1705) and has been accepted by the Medicines and Healthcare products Regulatory Agency (MHRA) for a clinical trials authorisation (reference CTA 12854/0248/001–0001). In addition, approval has been granted from the Administration of Radioactive Substances Advisory Committee. The results of this trial will be disseminated through publication in scientific journals and presentation at national and international conferences, and a lay summary will be available on our website.Trial registration numbersISRCTN14616801 and EudraCT- 2018-003089-14.


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