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Effect of prebiotics, probiotics, synbiotics on depression: results from a meta-analysis.
Zhang, Q, Chen, B, Zhang, J, Dong, J, Ma, J, Zhang, Y, Jin, K, Lu, J
BMC psychiatry. 2023;23(1):477
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Major depressive disorder (MDD) is a mood disorder that impairs psychosocial function and quality of life. Recent studies show that prebiotics, probiotics, and synbiotics reveal a novel way to treat psychiatric disorders such as depression through the microbiota-gut-brain axis. The aim of this study was to evaluate the effectiveness of prebiotics, probiotics and synbiotics in alleviating depressive symptoms. This study was a meta-analysis of thirteen studies with a total of 786 participants who were allocated to the intervention group (n=427) and the placebo group (n=359). Results showed that the overall effects of probiotics, prebiotics and synbiotics on depressive symptoms were significantly superior to those of placebo. Additionally, biological sex was a vital factor that influenced patients’ responses to the treatment. Authors concluded that agents that manipulate gut microbiota might become a novel approach to treat patients with mild-to-moderate depression.
Abstract
Accumulating studies have shown the effects of gut microbiota management tools in improving depression. We conducted a meta-analysis to evaluate the effects of prebiotics, probiotics, and synbiotics on patients with depression. We searched six databases up to July 2022. In total, 13 randomized controlled trials (RCTs) with 786 participants were included. The overall results demonstrated that patients who received prebiotics, probiotics or synbiotics had significantly improved symptoms of depression compared with those in the placebo group. However, subgroup analysis only confirmed the significant antidepressant effects of agents that contained probiotics. In addition, patients with mild or moderate depression could both benefit from the treatment. Studies with a lower proportion of females reported stronger effects for alleviating depressive symptoms. In conclusion, agents that manipulate gut microbiota might improve mild-to-moderate depression. It is necessary to further investigate the benefits of prebiotic, probiotic and synbiotic treatments relative to antidepressants and follow up with individuals over a longer time before these therapies are implemented in clinical practice.
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Psychobiotic Lactobacillus plantarum JYLP-326 relieves anxiety, depression, and insomnia symptoms in test anxious college via modulating the gut microbiota and its metabolism.
Zhu, R, Fang, Y, Li, H, Liu, Y, Wei, J, Zhang, S, Wang, L, Fan, R, Wang, L, Li, S, et al
Frontiers in immunology. 2023;14:1158137
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Test anxiety, characterised by feelings of failure, tension, and worrying when an individual faces a vital test for promoting, occurs prevalently among college students. Lactobacillus plantarum, has become increasingly popular in reducing the severity of anxiety and depression in stressed animal models. The main aim of this study was to evaluate the psychological effects of Lactobacillus plantarum JYLP-326 (JYLP-326) on exam stress-induced behaviours like anxiety, depression, and insomnia. This study enrolled 60 anxious and 30 un-anxious undergraduates preparing for the approaching exams. Out of the 60 anxious participants, 30 were selected randomly to receive the probiotic product and the other 30 received a placebo product. The 30 un-anxious students were assigned as the healthy control group. Results demonstrated that the intervention of JYLP-326 is effective in alleviating exam stress-induced symptoms in college students. Furthermore, it also protected against exam stress-induced dysbiosis of the gut microbiota and the disturbances of faecal metabolomic. Authors conclude that the changed gut microbiota genera and faecal metabolites were closely associated with stress-related symptoms like anxiety/depression and insomnia, indicating that they might be regarded as biomarkers for diagnosing and treating stress and anxiety disorders.
Abstract
INTRODUCTION Test anxiety is a common issue among college students, which can affect their physical and psychological health. However, effective interventions or therapeutic strategies are still lacking. This study aims to evaluate the potential effects of Lactobacillus plantarum JYLP-326 on test anxious college students. METHODS Sixty anxious students were enrolled and randomly allocated to the placebo group and the probiotic group. Both groups were instructed to take placebo and JYLP-326 products twice per day for three weeks, respectively. Thirty unanxious students with no treatments were assigned to a regular control group. The anxiety, depression, and insomnia questionnaires were used to measure students' mental states at the baseline and the end of this study. 16S rRNA sequencing and untargeted metabolomics were performed to analyze the changes in the gut microbiota and fecal metabolism. RESULTS The questionnaire results suggested that JYLP-326 administration could relieve the symptoms of anxiety, depression, and insomnia in test anxious students. The gut microbiomes of the placebo group showed a significantly greater diversity index than the control group (p < 0.05). An increased abundance of Bacteroides and Roseburia at the genus level was observed in the placebo group, and the relative abundance of Prevotella and Bifidobacterium decreased. Whereas, JYLP-326 administration could partly restore the disturbed gut microbiota. Additionally, test anxiety was correlated with disordered fecal metabolomics such as a higher Ethyl sulfate and a lower Cyclohexylamine, which could be reversed after taking JYLP-326. Furthermore, the changed microbiota and fecal metabolites were significantly associated with anxiety-related symptoms. CONCLUSION The results indicate that the intervention of L. plantarum JYLP-326 could be an effective strategy to alleviate anxiety, depression, and insomnia in test anxious college students. The potential mechanism underlying this effect could be related to the regulation of gut microbiota and fecal metabolites.
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Acceptability, Tolerability, and Estimates of Putative Treatment Effects of Probiotics as Adjunctive Treatment in Patients With Depression: A Randomized Clinical Trial.
Nikolova, VL, Cleare, AJ, Young, AH, Stone, JM
JAMA psychiatry. 2023;80(8):842-847
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About 60% of patients with major depressive disorder (MDD) do not fully respond to anti-depressant treatments. The microbiota-gut-brain axis is thought to be involved in the development of MDD, making the microbiome a promising target for new treatments. The aim of this double-blind, randomised, placebo-controlled trial, including 50 adult patients with major depressive disorder, was to evaluate the tolerability, acceptability and efficacy of a multi-strain probiotic supplement for 8 weeks as an adjunctive to antidepressant drugs. There were no serious adverse events; all reported non-serious events were of gastrointestinal nature and more common in the probiotic group (it was not reported whether the difference was statistically significant). A high adherence rate of 97.2% suggests a high level of acceptability. Depressive mood symptoms improved significantly more in the probiotic group. Greater improvements in anxiety in the probiotic were also seen in some, but not all anxiety scales. The authors concluded that a multi-strain probiotic supplement is a promising adjunct to anti-depressant treatment in patients with MDD, with high tolerability and acceptability.
Abstract
IMPORTANCE The microbiota-gut-brain axis is a promising target for novel treatments for mood disorders, such as probiotics. However, few clinical trials have been conducted, and further safety and efficacy data are needed to support this treatment approach. OBJECTIVE To provide acceptability and tolerability data and estimates of intervention effect size for probiotics as adjunctive treatment for patients with major depressive disorder (MDD). DESIGN, SETTING, AND PARTICIPANTS In this single-center, double-blind, placebo-controlled pilot randomized clinical trial, adults aged 18 to 55 years with MDD taking antidepressant medication but having an incomplete response were studied. A random sample was recruited from primary and secondary care services and general advertising in London, United Kingdom. Data were collected between September 2019 and May 2022 and analyzed between July and September 2022. INTERVENTION Multistrain probiotic (8 billion colony-forming units per day) or placebo daily for 8 weeks added to ongoing antidepressant medication. MAIN OUTCOMES AND MEASURES The pilot outcomes of the trial were retention, acceptability, tolerability, and estimates of putative treatment effect on clinical symptoms (depression: Hamilton Depression Rating Scale [HAMD-17] and Inventory of Depressive Symptomatology [IDS] scores; anxiety: Hamilton Anxiety Rating Scale [HAMA] and General Anxiety Disorder [GAD-7] scores) to be used as indicators for a definitive trial. RESULTS Of 50 included participants, 49 received the intervention and were included in intent-to-treat analyses; of these, 39 (80%) were female, and the mean (SD) age was 31.7 (9.8) years. A total of 24 were randomized to probiotic and 25 to placebo. Attrition was 8% (1 in the probiotic group and 3 in the placebo group), adherence was 97.2%, and there were no serious adverse reactions. For the probiotic group, mean (SD) HAMD-17 scores at weeks 4 and 8 were 11.00 (5.13) and 8.83 (4.28), respectively; IDS, 30.17 (11.98) and 25.04 (11.68); HAMA, 11.71 (5.86) and 8.17 (4.68); and GAD-7, 7.78 (4.12) and 7.63 (4.77). For the placebo group, mean (SD) HAMD-17 scores at weeks 4 and 8 were 14.04 (3.70) and 11.09 (3.22), respectively; IDS, 33.82 (9.26) and 29.64 (9.31); HAMA, 14.70 (5.47) and 10.95 (4.48); and GAD-7, 10.91 (5.32) and 9.48 (5.18). Standardized effect sizes (SES) from linear mixed models demonstrated that the probiotic group attained greater improvements in depressive symptoms according to HAMD-17 scores (week 4: SES, 0.70; 95% CI, 0.01-0.98) and IDS Self Report scores (week 8: SES, 0.64; 95% CI, 0.03-0.87) as well as greater improvements in anxiety symptoms according to HAMA scores (week 4: SES, 0.67; 95% CI, 0-0.95; week 8: SES, 0.79; 95% CI, 0.06-1.05), but not GAD-7 scores (week 4: SES, 0.57; 95% CI, -0.01 to 0.82; week 8: SES, 0.32; 95% CI, -0.19 to 0.65), compared with the placebo group. CONCLUSIONS AND RELEVANCE The acceptability, tolerability, and estimated effect sizes on key clinical outcomes are promising and encourage further investigation of probiotics as add-on treatment for people with MDD in a definitive efficacy trial. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03893162.
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Effect of short-term, high-dose probiotic supplementation on cognition, related brain functions and BDNF in patients with depression: a secondary analysis of a randomized controlled trial.
Schneider, E, Doll, JPK, Schweinfurth, N, Kettelhack, C, Schaub, AC, Yamanbaeva, G, Varghese, N, Mählmann, L, Brand, S, Eckert, A, et al
Journal of psychiatry & neuroscience : JPN. 2023;48(1):E23-E33
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Major depressive disorder (MDD) is often thought of as being solely a mood disorder. However, several studies have shown that sufferers can also experience decreased brain function such as memory loss and poor attention. Current therapies for MDD focus on the balancing of mood and leaves the problem of reduced brain function unattended. The gut microbiota has recently been shown to influence brain function and altered gut microbiota composition has been seen in individuals with MDD. Targeting the gut microbiota may therefore represent a novel target for MDD treatments. This secondary analysis of a randomised control trial aimed to determine whether a probiotic multistrain supplement could improve brain function in 60 individuals with depression. The results showed that probiotics improved the brain function in two different ways, the immediate recall of words, and the improvement of decreased neural function in the hippocampal part of the brain, which has been associated with MDD. It was concluded that probiotic supplementation can enhance verbal episodic memory and improve neural function associated with impaired brain function in MDD. This study could be used by healthcare professionals to understand that the health of the gut microbiota can have an influence on brain function and that probiotics may help individuals with MDD who are suffering from poorer memory.
Abstract
BACKGROUND In major depressive disorder (MDD), cognitive dysfunctions strongly contribute to functional impairments but are barely addressed in current therapies. Novel treatment strategies addressing cognitive symptoms in depression are needed. As the gut microbiota-brain axis is linked to depression and cognition, we investigated the effect of a 4-week high-dose probiotic supplementation on cognitive symptoms in depression. METHODS This randomized controlled trial included 60 patients with MDD, of whom 43 entered modified intention-to-treat analysis. A probiotic supplement or indistinguishable placebo containing maltose was administered over 31 days in addition to treatment as usual for depression. Participant scores on the Verbal Learning Memory Test (VLMT), Corsi Block Tapping Test, and both Trail Making Test versions as well as brain-derived neurotrophic factor levels were assessed at 3 different time points: before, immediately after and 4 weeks after intervention. Additionally, brain activation changes during working memory processing were investigated before and immediately after intervention. RESULTS We found a significantly improved immediate recall in the VLMT in the probiotic group immediately after intervention, and a trend for a time × group interaction considering all time points. Furthermore, we found a time × group interaction in hippocampus activation during working memory processing, revealing a remediated hippocampus function in the probiotic group. Other measures did not reveal significant changes. LIMITATIONS The modest sample size resulting from our exclusion of low-compliant cases should be considered. CONCLUSION Additional probiotic supplementation enhances verbal episodic memory and affects neural mechanisms underlying impaired cognition in MDD. The present findings support the importance of the gut microbiota-brain axis in MDD and emphasize the potential of microbiota-related regimens to treat cognitive symptoms in depression. CLINICAL TRIAL REGISTRATION clinicaltrials.gov identifier NCT02957591.
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Effect of a dietary intervention based on the Mediterranean diet on the quality of life of patients recovered from depression: Analysis of the PREDIDEP randomized trial.
Cabrera-Suárez, BM, Lahortiga-Ramos, F, Sayon-Orea, C, Hernández-Fleta, JL, González-Pinto, A, Molero, P, Vega-Pérez, R, Sánchez-Villegas, A
Experimental gerontology. 2023;175:112149
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Unipolar depression is a prevalent and disabling condition that negatively influences quality of life. Patients with depression are more vulnerable to have a poorer health-related quality of life (HRQoL). The aim of this study was to assess the effect of 2-year intervention with Mediterranean Diet enriched with extra virgin olive oil on HRQoL. This study is a multicentre, randomised, controlled, single-blind trial. The study included 52 men and 144 women aged between 18 and 86 years who had suffered at least one depression episode and who were in a stage of clinical remission. The participants were randomly assigned to the intervention or control group. Results show that a Mediterranean diet–based nutritional intervention enriched with extra virgin olive oil compared with usual care, resulted in a significantly greater increase in HRQoL in recovered depressed patients. This association was greater for the mental dimensions rather than the physical dimensions. Furthermore, this association was also observed for participants aged 60 or more. Authors conclude that since depression is an important condition for its high prevalence, economic cost and personal suffering, it is important to evaluate cost-effective, safe, and inexpensive interventions, such as Mediterranean Diet nutritional interventions.
Abstract
INTRODUCTION There is substantial evidence supporting that improving diet quality leads to improved health-related quality of life (HRQoL). Our major aim was to assess the effectiveness of a Mediterranean diet-based nutritional intervention to improve HRQoL in the context of a secondary prevention trial of depression. Secondarily to assess its effectiveness among adults aged 60 or more years. METHODS The PREDIDEP study is a 2-year multicentre, randomized, single-blinded nutritional trial. At baseline and at 1-year and 2-year follow-up, SF-36 health survey questionnaire was collected to evaluate participants' HRQoL (total and specific range for each of the 8 dimensions: 0 to 100 points). Mixed effect linear models were used to assess changes in HRQoL according to adherence to the Mediterranean diet. The trial was registered at ClinicalTrials.govNCT03081065. RESULTS After 2 years of intervention, the Mediterranean Diet intervention group compared to control group (without nutritional intervention, only usual clinical care) showed an improvement in some dimensions of HRQoL such as Mental Health (7.22; 95 % CI = 2.22-12.22) (between-group difference: 6.79; 95 % CI -0.14-13.73, p = 0.055); Vitality (9.51; 95 % CI = 4.00-15.03) (between-group difference: 9.00; 95 % CI 1.75-16.25, p = 0.020); Mental Summary Component (2.83; 95 % CI = 0.55-5.11) (between-group difference: 1.17; 95 % CI = -1.96-4.30, p = 0.462); and General Health (10.70; 95 % CI = 5.58-15.81) (between-group difference: 6.20; 95 % CI = -0.89-13.28, p = 0.086). Similar results were observed for participants aged 60 or more years. CONCLUSION The intervention based on Mediterranean diet in patients with previous depression seems to be effective in improving HRQoL, especially the mental dimensions. This effect is also observed among participants aged 60 or more years.
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Effect of vitamin D supplementation on depression in older Australian adults.
Rahman, ST, Waterhouse, M, Romero, BD, Baxter, C, English, DR, Almeida, OP, Berk, M, Ebeling, PR, Armstrong, BK, McLeod, DSA, et al
International journal of geriatric psychiatry. 2023;38(1):e5847
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Depression can considerably impair daily function. However, although medications and psychological therapy can be effective in treating depression, non‐compliance with and/or side effects of antidepressants are common. Thus, identifying alternative or adjunctive therapies to prevent or treat depression may help to overcome some limitations of current management strategies. The aim of this study was to examine whether supplementing older Australians with monthly doses of 60,000 IU of vitamin D3 for 5 years would reduce depressive symptoms or incidence of antidepressant use, as a surrogate for a formal diagnosis of depression. This study used data from the D‐Health Trial, a large population‐based randomised controlled trial. Authors randomly selected potential participants aged between 60 and 79 years from the Australian Commonwealth Electoral Roll. The participants who accepted the invitation were randomly allocated to either 60,000 IU of cholecalciferol (vitamin D3) or placebo in a 1:1 ratio. Results show that there wasn’t an overall benefit of monthly supplementation with 60,000 IU of vitamin D for up to 5 years on measures of depression. However, pre‐specified subgroup analyses suggested a potential beneficial effect of vitamin D supplementation in people taking antidepressants at baseline or with lower predicted baseline vitamin D3 concentration. However there was an unfavourable effect in participants with a body mass index <25 kg/m2 or those with higher predicted baseline vitamin D3 concentration. Authors conclude that routine supplementation with vitamin D in populations with a low prevalence of vitamin D deficiency is unlikely to be of benefit for depression and may cause harm in people with low body mass index or normal vitamin D status.
Abstract
OBJECTIVES To investigate whether vitamin D supplementation reduces depressive symptoms and incidence of antidepressant use. METHODS We used data from the D-Health Trial (N = 21,315), a randomized double-blind placebo-controlled trial of monthly vitamin D3 for the prevention of all-cause mortality. Participants were Australians aged 60-84 years. Participants completed the Patient Health Questionnaire (PHQ-9) at 1, 2 and 5 years after randomization to measure depressive symptoms; national prescribing records were used to capture antidepressant use. We used mixed models and survival models. RESULTS Analyses of PHQ-9 scores included 20,487 participants (mean age 69·3 years, 46% women); the mean difference (MD) in PHQ-9 score (vitamin D vs. placebo) was 0·02 (95% CI -0·06, 0·11). There was negligible difference in the prevalence of clinically relevant depression (PHQ-9 score ≥10) (odds ratio 0·99; 95% CI 0·90, 1·08). We included 16,670 participants in the analyses of incident antidepressant use (mean age 69·4 years, 43% women). Incidence of antidepressant use was similar between the groups (hazard ratio [HR] 1·04; 95% CI 0·96, 1·12). In subgroup analyses, vitamin D improved PHQ-9 scores in those taking antidepressants at baseline (MD -0·25; 95% CI -0·49, -0·01; p-interaction = 0·02). It decreased risk of antidepressant use in participants with predicted 25(OH)D concentration <50 nmol/L (HR 0·88; 95% CI 0·75, 1·02; p-interaction = 0·01) and increased risk in those with predicted 25(OH)D ≥ 50 nmol/L (HR 1·10; 95% CI 1·01, 1·20). CONCLUSION Monthly supplementation with high-dose vitamin D3 was not of benefit for measures of depression overall, but there was some evidence of benefit in subgroup analyses. CLINICAL TRIAL REGISTRATION The trial is registered on the Australian New Zealand Clinical Trials Registry: ACTRN12613000743763. https://www.anzctr.org.au/.
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HOMEFOOD randomised trial - Six-month nutrition therapy improves quality of life, self-rated health, cognitive function, and depression in older adults after hospital discharge.
Blondal, BS, Geirsdottir, OG, Halldorsson, TI, Beck, AM, Jonsson, PV, Ramel, A
Clinical nutrition ESPEN. 2022;48:74-81
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It is well known that older people are at a higher risk for nutritional inadequacy which is accompanied by depression, impaired cognitive function, and poor overall health. In this secondary analysis of a randomised controlled assessor-blinded dietary intervention trial, the authors examined the effects of six months of nutritional therapy on quality of life, self-rated health, cognitive function, and depression in elderly patients aged 65 years and over. The participants in the intervention group received nutritional therapy (HOMEFOOD) education to overcome malnutrition, which included dietary recommendations to ensure an adequate nutritional intake of energy and protein through diet and additional supplemental protein and energy-rich foods. After six months of nutritional therapy, the intervention group showed improvement in cognitive function, self-rated health, depression score, and quality of life scores, as well as improvements in measures related to weight gain. Further studies need to be conducted in order to determine if nutritional therapy provides additional benefits to older people. However, healthcare professionals can use the results of this study to better understand how nutritional therapy can improve the quality of life and health of older people in comparison to standard care, so they can better advise their patients.
Abstract
BACKGROUND AND AIMS Malnutrition is common among older adults and is related to quality of life, cognitive function, and depression. To what extent nutrition interventions can improve these outcomes remains unclear. The aim of this study was to investigate the effect of nutrition therapy on health-related quality of life (EQ-5D), self-rated health, cognitive function, and depression in community dwelling older adults recently discharged from hospital. METHODS Participants (>65 years) were randomised into an intervention (n = 53) and a control group (n = 53). The intervention group received individualised nutrition therapy based on the nutrition care process including 5 home visits and 3 phone calls, in combination with freely delivered energy- and protein-rich foods and oral nutrition supplements for six months after hospital discharge. EQ-5D, self-rated health, Mini-Mental-State-Examination (MMSE), and the Centre for Epidemiologic Studies Depression - IOWA (CES-D) scale were measured at baseline and at endpoint. RESULTS Two subjects dropped out, one from each arm. The control group experienced an increase in depressive symptoms and a decrease in self-rated health during the study period, while the intervention group experienced increases in cognitive function, self-rated health, and EQ-5D resulting in significant endpoint differences between the groups: EQ-5D (0.102, P = 0.001); self-rated health: 15.876 (P < 0.001); MMSE 1.701 (P < 0.001); depressive symptoms: - 3.072 (P < 0.001); all in favour of the intervention group. Improvements during the intervention in MMSE, self-rated health, and CES-D were significantly related to body weight gain in a linear way. CONCLUSION Cognitive function and mental well-being worsen or stagnate in older adults who receive standard care after hospital discharge. However, a six-month nutrition therapy improves these outcomes leading to statistically and clinically significant endpoint differences between the groups. As improvements were related to body weight gain after hospital discharge, we conclude that the increase in dietary intake, with focus on energy and protein density, and changes in body weight might have contributed to better cognitive function and mental well-being in older adults after the intervention.
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Effects of a multicomponent resistance-based exercise program with protein, vitamin D and calcium supplementation on cognition in men with prostate cancer treated with ADT: secondary analysis of a 12-month randomised controlled trial.
Mundell, NL, Owen, PJ, Dalla Via, J, Macpherson, H, Daly, RM, Livingston, PM, Rantalainen, T, Foulkes, S, Millar, J, Murphy, DG, et al
BMJ open. 2022;12(6):e060189
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Androgen deprivation therapy (ADT) for local and advanced prostate cancer (PCa) is effective at reducing androgens, and thus inhibiting tumour progression. However, testosterone reduces the production of a highly neurotoxic protein (amyloid beta peptide 40), which is linked with the development of dementia and Alzheimer’s disease. The aim of this study was to investigate the effects of a multi-component resistance-based exercise programme with daily protein, vitamin D and calcium supplementation on cognitive function compared with usual care in PCa survivors treated with ADT. This study is a secondary analysis of a 12-month single-blinded, two-arm randomised controlled trial. Participants (n = 70) were randomised (1:1 ratio) to either: (a) multi-component exercise intervention including progressive resistance training, body-weight impact and balance exercises, as well as a daily nutritional supplement containing whey protein, calcium and vitamin D, or (b) usual care control receiving 1000 IU vitamin D only. Results show that a multicomponent exercise training and nutritional supplementation intervention did not improve cognitive function in men treated with ADT for PCa compared with usual care. Authors conclude that cognitive decline associated with ADT may mechanistically differ to that of general age-related cognitive declines, thus it is important that future studies also examine other intervention modalities.
Abstract
OBJECTIVES The aim of this preplanned secondary analysis of a 12-month randomised controlled trial was to investigate the effects of a multicomponent exercise programme combined with daily whey protein, calcium and vitamin D supplementation on cognition in men with prostate cancer treated with androgen deprivation therapy (ADT). DESIGN 12-month, two-arm, randomised controlled trial. SETTING University clinical exercise centre. PARTICIPANTS 70 ADT-treated men were randomised to exercise-training plus supplementation (Ex+ Suppl, n=34) or usual care (control, n=36). INTERVENTION Men allocated to Ex + Suppl undertook thrice weekly resistance training with weight-bearing exercise training plus daily whey protein (25 g), calcium (1200 mg) and vitamin D (2000 IU) supplementation. PRIMARY AND SECONDARY OUTCOME MEASURES Cognition was assessed at baseline, 6 and 12 months via a computerised battery (CogState), Trail-making test, Rey auditory-verbal learning test and Digit span. Data were analysed with linear mixed models and an intention-to-treat and prespecified per-protocol approach (exercise-training: ≥66%, nutritional supplement: ≥80%). RESULTS Sixty (86%) men completed the trial (Ex + Suppl, n=31; control, n=29). Five (7.1%) men were classified as having mild cognitive impairment at baseline. Median (IQR) adherence to the exercise and supplement was 56% (37%-82%) and 91% (66%-97%), respectively. Ex + Suppl had no effect on cognition at any time. CONCLUSIONS A 12-month multicomponent exercise training and supplementation intervention had no significant effect on cognition in men treated with ADT for prostate cancer compared with usual care. Exercise training adherence below recommended guidelines does not support cognitive health in men treated with ADT for prostate cancer. TRIAL REGISTRATION NUMBER Australian and New Zealand Clinical Trial Registry (ACTRN12614000317695, registered 25/03/2014) and acknowledged under the Therapeutic Goods Administration Clinical Trial Notification Scheme (CT-2015-CTN-03372-1 v1).
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Efficacy of Zemedy, a Mobile Digital Therapeutic for the Self-management of Irritable Bowel Syndrome: Crossover Randomized Controlled Trial.
Hunt, M, Miguez, S, Dukas, B, Onwude, O, White, S
JMIR mHealth and uHealth. 2021;9(5):e26152
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Cognitive behavioural therapy (CBT) is a proven treatment method to tackle many psychiatric issues. Irritable bowel syndrome (IBS) is considered a chronic gastrointestinal disorder with psychiatric comorbidity. However, patients find it difficult to access CBT for IBS management. As per previous research findings, web-based and telephone-based CBT, self-help CBT books and CBT treatment manuals offer promising therapeutic effects in improving IBS. Therefore, this crossover randomised controlled trial aimed to look at the efficacy of Zemedy, a mobile digital therapeutic application that provides a comprehensive CBT programme to IBS patients. This study found that Zemedy is an effective modality that increases access to effective CBT treatment for IBS patients. Results showed significant improvement in gastrointestinal symptoms, irritable bowel syndrome quality of life, gastrointestinal cognition, visceral sensitivity, fear of food, depression, and improved health-related quality of life in 62 IBS patients enrolled in the immediate treatment group. Further robust studies are required to determine the efficacy of digital applications in IBS patients with significantly higher psychiatric comorbidity. Healthcare practitioners can use the results of the study to understand the importance of digital applications and make them part of intervention strategies.
Abstract
BACKGROUND Patients with irritable bowel syndrome (IBS) experience abdominal pain, altered bowel habits, and defecation-related anxiety, which can result in reduced productivity and impaired health-related quality of life (HRQL). Cognitive behavioral therapy (CBT) has been shown to reduce symptoms of IBS and to improve HRQL, but access to qualified therapists is limited. Smartphone-based digital therapeutic interventions have potential to increase access to guided CBT at scale, but require careful study to assess their benefits and risks. OBJECTIVE The aim of this study was to test the efficacy of a novel app, Zemedy, as a mobile digital therapeutic that delivers a comprehensive CBT program to individuals with IBS. METHODS This was a crossover randomized controlled trial. Participants were recruited online and randomly allocated to either immediate treatment (n=62) or waitlist control (n=59) groups. The Zemedy app consists of 8 modules focusing on psychoeducation, relaxation training, exercise, the cognitive model of stress management, applying CBT to IBS symptoms, reducing avoidance through exposure therapy, behavioral experiments, and information about diet. Users interact with a chatbot that presents the information and encourages specific plans, homework, and exercises. The treatment was fully automated, with no therapist involvement or communication. At baseline and after 8 weeks, participants were asked to complete the battery of primary (Irritable Bowel Syndrome Quality of Life [IBS-QOL], Gastrointestinal Symptom Rating Scale [GSRS]) and secondary (Fear of Food Questionnaire [FFQ], Visceral Sensitivity Index [VSI], Gastrointestinal Cognition Questionnaire [GI-COG], Depression Anxiety Stress Scale [DASS], and Patient Health Questionnaire-9 [PHQ-9]) outcome measures. Waitlist controls were then offered the opportunity to crossover to treatment. All participants were assessed once more at 3 months posttreatment. RESULTS Both intention-to-treat and completer analyses at posttreatment revealed significant improvement for the immediate treatment group compared to the waitlist control group on both primary and secondary outcome measures. Gains were generally maintained at 3 months posttreatment. Scores on the GSRS, IBS-QoL, GI-COG, VSI, and FFQ all improved significantly more in the treatment group (F1,79=20.49, P<.001, Cohen d=1.01; F1,79=20.12, P<.001, d=1.25; F1,79=34.71, P<.001, d=1.47; F1,79=18.7, P<.001, d=1.07; and F1,79=12.13, P=.001, d=0.62, respectively). Depression improved significantly as measured by the PHQ-9 (F1,79=10.5, P=.002, d=1.07), and the DASS Depression (F1,79=6.03, P=.02, d=.83) and Stress (F1,79=4.47, P=.04, d=0.65) subscales in the completer analysis but not in the intention-to-treat analysis. The impact of treatment on HRQL was mediated by reductions in catastrophizing and visceral sensitivity. CONCLUSIONS Despite its relatively benign physical profile, IBS can be an extraordinarily debilitating condition. Zemedy is an effective modality to deliver CBT for individuals with IBS, and could increase accessibility of this evidence-based treatment. TRIAL REGISTRATION ClinicalTrials.gov NCT04170686; https://www.clinicaltrials.gov/ct2/show/NCT04170686.
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Probiotics, Prebiotics and Postbiotics on Mitigation of Depression Symptoms: Modulation of the Brain-Gut-Microbiome Axis.
Chudzik, A, Orzyłowska, A, Rola, R, Stanisz, GJ
Biomolecules. 2021;11(7)
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The bidirectional communication pathway between the gut microbiota and the central nervous system has been termed the brain-gut-microbiome axis. Increased investigation of this pathway has found the gut bacteria to impact metabolism and the brain, suggesting that modulating the microbiome may elicit change in mental health. The aim of this review is to discuss the current findings in both animal and human studies regarding the use of pro-, pre- and post-biotics in the prevention and treatment of depressive disorders. Studies show that modulating the bacteria in the gut may reduce inflammation, decrease stress hormone levels and adjust the levels of neurotransmitters in the brain. These changes consequently lead to the reduction of depressive symptoms and improvement in mood. While these results are promising, larger clinical trials are needed that include biochemical measurements and fecal microbiome analysis in addition to validated questionnaires. With this in mind, the authors conclude there is huge potential in the role of nutrition as a therapeutic target for neurological and mental health conditions.
Abstract
The brain-gut-microbiome axis is a bidirectional communication pathway between the gut microbiota and the central nervous system. The growing interest in the gut microbiota and mechanisms of its interaction with the brain has contributed to the considerable attention given to the potential use of probiotics, prebiotics and postbiotics in the prevention and treatment of depressive disorders. This review discusses the up-to-date findings in preclinical and clinical trials regarding the use of pro-, pre- and postbiotics in depressive disorders. Studies in rodent models of depression show that some of them inhibit inflammation, decrease corticosterone level and change the level of neurometabolites, which consequently lead to mitigation of the symptoms of depression. Moreover, certain clinical studies have indicated improvement in mood as well as changes in biochemical parameters in patients suffering from depressive disorders.