1.
A multidomain intervention against cognitive decline in an at-risk-population in Germany: Results from the cluster-randomized AgeWell.de trial.
Zülke, AE, Pabst, A, Luppa, M, Roehr, S, Seidling, H, Oey, A, Cardona, MI, Blotenberg, I, Bauer, A, Weise, S, et al
Alzheimer's & dementia : the journal of the Alzheimer's Association. 2024;20(1):615-628
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Plain language summary
Due to ageing populations, there is a rapid increase in people living with dementia. A number of modifiable risk factors have been identified, including obesity, excessive alcohol consumption, diabetes mellitus, depression, physical inactivity, smoking and social isolation. The aim of this cluster-randomised controlled trial, including 1030 participants at risk of developing dementia aged 60-77, was to evaluate the effectiveness of a multidomain intervention which included optimisation of nutrition and medication, and physical, social, and cognitive activity for two years compared to standard care. There was no benefit of the intervention for the primary outcome global cognitive performance. The intervention had a positive effect on the secondary outcome health-related quality of life but did not have any significant effect on quality of life, depressive symptoms, social inclusion, activities of daily living and instrumental activities of daily living. The study period coincided with the COVID-19 pandemic. Significantly more participants than controls reported perceived COVID-19-related restrictions with regards to nutrition, whilst there was no such differences between groups for physical, cognitive or social activity. Better adherence to the nutrition and social activity components of the programme were associated with better global cognitive performance, whilst there was no association with physical and cognitive activity.
Expert Review
Conflicts of interest:
None
Take Home Message:
- Nutrition counselling based on the guidelines of the German Society for Nutrition, in association with other lifestyle counselling and optimisation of medication, does not improve GCP.
Evidence Category:
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X
A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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B: Systematic reviews including RCTs of limited number
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C: Non-randomized trials, observational studies, narrative reviews
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D: Case-reports, evidence-based clinical findings
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E: Opinion piece, other
Summary Review:
Introduction
The aim of this study was to evaluate the effectiveness of the AgeWell.de programme which targets modifiable risk factors for dementia.
Methods
- Cluster-randomised, controlled trial (clustered by participating general practitioners).
- Intervention: nutritional counselling (based on the guidelines by the German Society for Nutrition), enhancement of physical and social activity, cognitive training, and the management of cardiovascular risk factors (overweight, smoking). Baseline individual face-to-face session with study nurse, followed by contact with the nurse after 2, 4 and 8 months, second face-to-face session with the nurse at 12 months and further contacts at 16 and 20 months. Endpoint assessments at 24 months.
- Controls: standard care.
- Sample size: 1030 adults aged 60-77 at increased risk of dementia, of which 819 completed the study and were included in the analysis.
- Primary outcome: global cognitive performance (GCP)
- Secondary outcomes: mortality, nursing home placement, activities of daily living (ADL), instrumental activities of daily living (IADL), quality of life (QOL), health-related (QOL), depressive symptoms, and social inclusion.
Results
- No significant difference in GCP, p=0.874. No difference in ADL (p=0.374), IADL (p=0.746), QOL (p=0.964), depressive symptoms (p=0.090) and social inclusion (p=0.495).
- Improvement in health-related QOL (AME = 0.198, 95% CI: 0.069, 0.328, p=0.003).
- Results for mortality and nursing home placement are not reported.
- Part of the study took place during the COVID-19 pandemic. More participants (9%) than controls (3.7%) reported perceived COVID-19-related restrictions with regards to nutrition (p=0.004). No such difference was observed for perceived restrictions regarding physical activity (p=0.328), cognitive activity (p=0.262) or social activity (p=0.192).
Conclusion
- The authors concluded that the multidomain intervention had no beneficial effects on GCP and that higher-intensity interventions and more ambitious goals may be needed.
Clinical practice applications:
- Nutrition counselling based on the guidelines of the German Society for Nutrition, in association with other lifestyle counselling and optimisation of medication, does not improve GCP.
Considerations for future research:
- Studies using more intensive and individualised interventions may evaluate whether such strategies are more beneficial for improving GCP.
- Studies of specific subgroups, e.g. based on lifestyle or medical risk factors, may help find more specific populations and interventions to help improve GCP.
Abstract
INTRODUCTION We investigated the effectiveness of a multidomain intervention to preserve cognitive function in older adults at risk for dementia in Germany in a cluster-randomized trial. METHODS Individuals with a Cardiovascular Risk Factors, Aging, and Dementia (CAIDE) risk score ≥ 9 aged 60 to 77 years were recruited. After randomization of their general practitioner (GP), patients received a multidomain intervention (including optimization of nutrition and medication, and physical, social, and cognitive activity) or general health advice and GP treatment as usual over 24 months. Primary outcome was global cognitive performance (composite z score, based on domain-specific neuropsychological tests). RESULTS Of 1030 participants at baseline, n = 819 completed the 24-month follow-up assessment. No differences regarding global cognitive performance (average marginal effect = 0.010, 95% confidence interval: -0.113, 0.133) were found between groups at follow-up. Perceived restrictions in intervention conduct by the COVID-19 pandemic did not impact intervention effectiveness. DISCUSSION The intervention did not improve global cognitive performance. HIGHLIGHTS Overall, no intervention effects on global cognitive performance were detected. The multidomain intervention improved health-related quality of life in the total sample. In women, the multidomain intervention reduced depressive symptoms. The intervention was completed during the COVID-19 pandemic.
2.
Eating in the lockdown during the Covid 19 pandemic; self-reported changes in eating behaviour, and associations with BMI, eating style, coping and health anxiety.
Coulthard, H, Sharps, M, Cunliffe, L, van den Tol, A
Appetite. 2021;161:105082
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The Covid-19 pandemic resulted in national lockdowns, which resulted in isolation within people’s homes. This cross-sectional survey examined changes in eating patterns and behaviour during lockdown. Of the 620 participants included in the study, eating higher energy density foods was more common in females with a higher BMI and higher health anxiety. Although there was a change in emotional eating behaviours across the sample as a whole, it was not in the expected direction, with many participants reporting a decrease in emotional eating after the implementation of lockdown. There were also increases in fruit and vegetable consumption and home prepared foods. Many of these behavioural responses were influenced by pre-lockdown tendencies. Therefore, it is important to consider these when understanding coping strategies during lockdown, and how to support clients as we come out of lockdown.
Expert Review
Conflicts of interest:
None
Take Home Message:
- National lockdowns, as seen during the 2020/21 Covid-19 pandemic, impacted eating behaviour and associations with BMI, eating style and health anxiety.
- Given the new nature of this research, it is not clear what impact confounding factors such as food insecurity had on changing eating behaviours.
- Disproportionate risks were seen in certain demographics and in those shielding due to their heightened risk from Covid-19.
- Retrospective and longitudinal studies to monitor the impact of lockdowns on eating behaviour and health anxiety are needed.
Evidence Category:
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A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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B: Systematic reviews including RCTs of limited number
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C: Non-randomized trials, observational studies, narrative reviews
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D: Case-reports, evidence-based clinical findings
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E: Opinion piece, other
Summary Review:
The role of eating behaviours and psychological responses during lockdown has become an area of interest, particularly with the uncertainty of going into future lockdowns. With Covid-19, and individual’s responses to it, being a relatively new research topic, there is not yet enough evidence for longitudinal outcomes of the findings in these studies. It is also difficult to ascertain the influence of confounding variables prior to the national lockdown, such as food insecurity, not accounted for due to the unpredictable start to the pandemic. There has also been disproportionate risks between certain demographics and their Covid-19 risk, therefore further research on the impact of this on health anxiety and subsequent eating behaviours is required. This highlights a wider need for continued research on the topic.
Clinical practice applications:
Those who had problematic eating behaviours and higher BMI pre lockdown will need to be supported with healthier coping practices if subsequent lockdowns occur, to prevent health related anxiety and consumption of high energy density foods. Furthermore, those who were shielding in their homes were also more likely to show an increase in emotional eating post lockdown. Therefore, clients who spent a large amount of lockdown shielding will need additional support, to develop coping strategies to prevent risk of emotional eating and health anxiety.
Considerations for future research:
Both retrospective and longitudinal studies monitoring the impact of eating behaviours and health anxiety pre and post lockdown are needed. This will help further the evidence base of the potential role of Covid-19 related health anxiety on eating patterns, coping strategies and dietary choices.
Abstract
The global coronavirus pandemic (Covid 19) resulted in national lockdowns where individuals were asked to isolate in their homes to stop the spread of the disease. Using a cross-sectional survey, the current paper aimed to examine self-reported changes in eating patterns and behaviour during the lockdown in the UK, and associations with BMI, demographic variables, eating styles, health anxiety, food insecurity and coping strategies. Participants (N = 620) were recruited online through social media advertising. The results showed that there were self-reported changes to food consumption during the lockdown across the sample. Increases in consumption of HED (high energy density) snack foods during the lockdown was associated with sex, pre-lockdown eating behaviour (emotional eating and uncontrolled eating), and Covid-specific health anxiety. Increases in positive eating practices such as eating more home prepared foods, and fruits and vegetables, were associated with adaptive coping strategies. Higher emotional eating (EE) during the lockdown was associated with a higher BMI, higher pre-lockdown EE and maladaptive coping strategies. Maladaptive coping strategies moderated the relationship between BMI and EE during the lockdown. In particular a higher BMI was associated with higher EE during the lockdown if an individual also had higher maladaptive coping strategies. These findings suggest that changes to eating behaviour may be part of a wider style of maladaptive or adaptive coping, particularly in those with a history of EE or uncontrolled eating. Preparing individuals to adopt more adaptive coping strategies during lockdown situations may be crucial to improving health during subsequent the lockdown events.
3.
A Randomized Controlled Trial of the Efficacy of Systemic Enzymes and Probiotics in the Resolution of Post-COVID Fatigue.
Rathi, A, Jadhav, SB, Shah, N
Medicines (Basel, Switzerland). 2021;8(9)
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Coronavirus disease-19 (Covid-19) usually lasts for 7-10 days but in a proportion of individuals, long-term symptoms may develop such as fatigue, which can last for at least 12 weeks. Disruptions to the immune system and parts of the cell which produce energy have been observed in these individuals. This randomised control trial of 200 individuals aimed to determine the combined effects of two different multi-enzyme and probiotic supplements; ImmunoSEB and ProbioSEB on Covid-19 induced fatigue. The results showed that supplementation resolved fatigue and lowered fatigue in those who were still fatigued after 14 days compared to taking a placebo. Mental fatigue was also reduced in the supplemented group compared to placebo. It was concluded that 14 days of supplementation with ImmunoSEB and ProbioSEB resolves post-Covid-19 fatigue. This study could be used by health care professionals to recommend the supplementation of ImmunoSEB and ProbioSEB to improve feelings of and in some case resolve fatigue associated with Covid-19.
Expert Review
Conflicts of interest:
None
Take Home Message:
- Multi-enzymes and specific probiotic strains are reported to show positive results in reducing mental and physical fatigue of post-COVID-19 infected patients.
- These multi-enzymes (Peptizyme SP, an enteric coated serratiopeptidase, bromelain, amylase, lysozyme, peptidase, catalase, papain, glucoamylase and lactoferrin) and probiotics (Bacillus coagulans, Bacillus subtilis, and Bacillus clausii) have also shown early effects (from day four of the intervention) on mental and physical fatigue.
Evidence Category:
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X
A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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B: Systematic reviews including RCTs of limited number
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C: Non-randomized trials, observational studies, narrative reviews
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D: Case-reports, evidence-based clinical findings
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E: Opinion piece, other
Summary Review:
This study reports on a randomized, multicentric, double-blind, placebo-controlled trial that was conducted in n=200 subjects with post-COVID-19 fatigue and without active SARSCoV-2 infection, living in India. This study sought to assess the efficacy of a multi-enzyme formulation administered with a probiotic complex on COVID-19-induced fatigue.
Subjects were between the ages of 18 and 75 years, with RT-PCR, confirmed diagnosis of COVID-19 at any time followed by an RT-PCR negative test who experienced fatigue and muscle weakness. Subjects were randomized to a test arm (n = 100), an oral supplement of a systemic enzyme complex and a probiotic complex for 14 days, or the control arm (n = 100) which used a placebo.
The multi-enzyme supplement formulation included Peptizyme SP, an enteric coated serratiopeptidase, bromelain, amylase, lysozyme, peptidase, catalase, papain, glucoamylase and lactoferrin. The probiotic supplement included, a blend of Bacillus coagulans LBSC (DSM 17654), Bacillus subtilis PLSSC (ATCC SD 7280) and Bacillus clausii 088AE (MCC 0538).
Treatment efficacy was compared using the Chalder Fatigue scale (CFQ-11), at various time points from days 1 to 14. At endpoint, 200/200 subjects finished the study.
Primary clinical outcomes were:
- The supplemental treatment resulted in the resolution of fatigue by 182 of 200 (91%) in the test arm compared to 30 of 200 (15%) in the control arm on day 14 (p<0.001)
- A beneficial effect was seen even at earlier time points, with a greater proportion of patients in the test arm being fatigue- free on days 4 (16% vs. 0%), 8 (44% vs. 2%), and 11 (87% vs. 7%) vs. the control arm (p<0.001).
The supplements were well tolerated with no adverse events reported.
Secondary clinical outcomes were:
- Subjects in the test arm showed a significant reduction in total as well as physical and mental fatigue scores at all time points vs. the control arm (p<0.001)
- On day 14, there was a significant reduction in all individual measures of physical fatigue (tiredness, need to rest, drowsiness, ability to do things, energy level, muscle strength and feeling of weakness) as well as mental fatigue (concentration, focus and memory) in the test arm vs. the control arm (p<0.001).
Clinical practice applications:
- There have been reports of post-viral fatigue syndrome up to 12 months in other coronavirus infections such as severe acute respiratory syndrome (SARS) and the Middle East respiratory syndrome (MERS). A lengthy post-infection fatigue impairs quality of life and has a significant impact on individuals, employers, and the healthcare system. It is therefore essential for clinicians to have early interventions to promote recovery of COVID-19 patients.
- Based on this study, practitioners could therefore consider multi-enzymes and probiotics together with other evidence-based multidisciplinary care approaches to improve functional status and quality of life in patients suffering from post-viral fatigue from COVID-19.
Considerations for future research:
- The treatment period of the study was a one-time intervention of 14 days with no long-term follow-up. A long-term follow-up of patients in future studies is needed to evaluate the potential of recurring fatigue.
- Future studies are also needed to replicate these findings and to test for certain inflammatory and immunity markers to provide further insight into the mechanism of action of supplementing with multi-enzymes, Bacillus coagulans, Bacillus subtilis, and Bacillus clausii.
- Additionally, further investigation is needed to evaluate the effectiveness of multi-enzymes, Bacillus coagulans, Bacillus subtilis, and Bacillus clausii in patients with persistent fatigue for six months or beyond to address the needs of patients suffering from chronic fatigue.
- All the subjects in the study were of Indian ethnicity, therefore further studies of other ethnicities are required.
- This study was capped at 75-year-olds, thus studies in older subjects are warranted.
- Conflict of interest statement: This study was fully funded by the manufacturer of the specialty enzymes and probiotics and the authors are paid employees of the manufacturer.
Abstract
Muscle fatigue and cognitive disturbances persist in patients after recovery from acute COVID-19 disease. However, there are no specific treatments for post-COVID fatigue. Objective: To evaluate the efficacy and safety of the health supplements ImmunoSEB (systemic enzyme complex) and ProbioSEB CSC3 (probiotic complex) in patients suffering from COVID-19 induced fatigue. A randomized, multicentric, double blind, placebo-controlled trial was conducted in 200 patients with a complaint of post-COVID fatigue. The test arm (n = 100) received the oral supplements for 14 days and the control arm (n = 100) received a placebo. Treatment efficacy was compared using the Chalder Fatigue scale (CFQ-11), at various time points from days 1 to 14. The supplemental treatment resulted in resolution of fatigue in a greater percentage of subjects in the test vs. the control arm (91% vs. 15%) on day 14. Subjects in the test arm showed a significantly greater reduction in total as well as physical and mental fatigue scores at all time points vs. the control arm. The supplements were well tolerated with no adverse events reported. This study demonstrates that a 14 days supplementation of ImmunoSEB + ProbioSEB CSC3 resolves post-COVID-19 fatigue and can improve patients' functional status and quality of life.
