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Journal of Cachexia, Sarcopenia and... Apr 2024There is no consensus on the optimal endpoint(s) in cancer cachexia trials. Endpoint variation is an obstacle when comparing interventions and their clinical value. The... (Review)
Review
There is no consensus on the optimal endpoint(s) in cancer cachexia trials. Endpoint variation is an obstacle when comparing interventions and their clinical value. The aim of this systematic review was to summarize and evaluate endpoints used to assess appetite and dietary intake in cancer cachexia clinical trials. A search for studies published from 1 January 1990 until 2 June 2021 was conducted using MEDLINE, Embase and Cochrane Central Register of Controlled Trials. Eligible studies examined cancer cachexia treatment versus a comparator in adults with assessments of appetite and/or dietary intake as study endpoints, a sample size ≥40 and an intervention lasting ≥14 days. Reporting was in line with PRISMA guidance, and a protocol was published in PROSPERO (2022 CRD42022276710). This review is part of a series of systematic reviews examining cachexia endpoints. Of the 5975 articles identified, 116 were eligible for the wider review series and 80 specifically examined endpoints of appetite (65 studies) and/or dietary intake (21 studies). Six trials assessed both appetite and dietary intake. Appetite was the primary outcome in 15 trials and dietary intake in 7 trials. Median sample size was 101 patients (range 40-628). Forty-nine studies included multiple primary tumour sites, while 31 studies involved single primary tumour sites (15 gastrointestinal, 7 lung, 7 head and neck and 2 female reproductive organs). The most frequently reported appetite endpoints were visual analogue scale (VAS) and numerical rating scale (NRS) (40%). The appetite item from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30/C15 PAL (38%) and the appetite question from North Central Cancer Treatment Group anorexia questionnaire (17%) were also frequently applied. Of the studies that assessed dietary intake, 13 (62%) used food records (prospective registrations) and 10 (48%) used retrospective methods (24-h recall or dietary history). For VAS/NRS, a mean change of 1.3 corresponded to Hedge's g of 0.5 and can be considered a moderate change. For food records, a mean change of 231 kcal/day or 11 g of protein/day corresponded to a moderate change. Choice of endpoint in cachexia trials will depend on factors pertinent to the trial to be conducted. Nevertheless, from trials assessed and available literature, NRS or EORTC QLQ C30/C15 PAL seems suitable for appetite assessments. Appetite and dietary intake endpoints are rarely used as primary outcomes in cancer cachexia. Dietary intake assessments were used mainly to monitor compliance and are not validated in cachexia populations. Given the importance to cachexia studies, dietary intake endpoints must be validated before they are used as endpoints in clinical trials.
Topics: Humans; Appetite; Cachexia; Eating; Neoplasms; Prospective Studies; Quality of Life; Retrospective Studies; Clinical Trials as Topic
PubMed: 38343065
DOI: 10.1002/jcsm.13434 -
Journal of the Academy of Nutrition and... Feb 2024Clinical studies have reported the beneficial effects of unfermented soy product consumption on blood lipids in various populations. However, contradictory results have...
BACKGROUND
Clinical studies have reported the beneficial effects of unfermented soy product consumption on blood lipids in various populations. However, contradictory results have been reported regarding the influence of unfermented soy product consumption on blood lipids in postmenopausal women.
OBJECTIVE
The aim of this systematic review and meta-analysis was to evaluate the effects of diets with unfermented soy products compared with diets without unfermented soy products on blood lipids in postmenopausal women.
METHODS
The Cochrane Library, PubMed, Scopus, Web of Science, and Embase electronic databases were searched for eligible randomized controlled trials (RCTs) published up to February 21, 2023. RCTs were included if they were published in English and investigated the effect of unfermented soy product consumption on blood lipids in postmenopausal women who had discontinued hormone replacement therapy at least 3 months before randomization. A random-effects model was used to calculate the overall effect size of the mean difference (MD) and 95% CI. Risk of bias was assessed using the Cochrane Risk-of-Bias Tool for Randomized Trials, version 2.
RESULTS
Twenty-nine RCTs involving 2,457 participants were included. The results showed that, compared with the control group that did not consume unfermented soy products, consumption of unfermented soy products significantly reduced total cholesterol (TC) (MD, -9.46 mg/dL [to convert mg/dL cholesterol to mmol/L, multiply mg/dL by 0.0259; to convert mmol/L cholesterol to mg/dL, multiply by 38.7]; 95% CI -15.04 to -3.89 mg/dL; P = .001) and triglycerides (TGs) (MD, -10.86 mg/dL [to convert mg/dL TGs to mmol/L, multiply mg/dL by 0.0113; to convert mmol/L TGs to mg/dL, multiply mmol/L by 88.6]; 95% CI -19.70 to -2.02 mg/dL; P = .016), while significantly increasing high-density lipoprotein cholesterol (MD, 2.32 mg/dL; 95% CI 0.87 to 3.76 mg/dL; P = .002) in postmenopausal women, but had no significant effect on low-density lipoprotein cholesterol (MD, -4.55 mg/dL; 95% CI -10.90 to 1.80 mg/dL; P = .160). Results of soy preparation subgroup analysis showed that soy isolate protein significantly reduced TC and soy protein-containing isoflavones significantly reduced TC and low-density lipoprotein cholesterol and increased high-density lipoprotein cholesterol. Furthermore, unfermented soy product consumption significantly reduced TC, low-density lipoprotein cholesterol, and TG levels in postmenopausal women with lipid disorders and TGs in healthy postmenopausal women.
CONCLUSIONS
The results showed that unfermented soy product consumption reduced TC and TG levels significantly, and increased high-density lipoprotein cholesterol levels in postmenopausal women. The findings of this review contribute to the evidence-base for dietary management of blood lipids in postmenopausal women.
PubMed: 38342411
DOI: 10.1016/j.jand.2024.02.006 -
Clinical Nutrition (Edinburgh, Scotland) Mar 2024Gestational diabetes mellitus (GDM) is a common condition in pregnancy, the prevalence of which has increased. Identifying modifiable risk factors for GDM, such as... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Gestational diabetes mellitus (GDM) is a common condition in pregnancy, the prevalence of which has increased. Identifying modifiable risk factors for GDM, such as dietary factors, could prevent or delay the onset of the condition. Our goal was to perform a comprehensive meta-analysis of cohort studies, to summarize the current evidence on the relationship between total, animal, and plant protein intake during pregnancy, as well as pre-pregnancy protein intake, and the risk of GDM.
METHODS
A literature search was completed using Scopus, PubMed, Web of Science, and Google Scholar up to January 2023 and references of retrieved relevant articles. Observational studies examining the association between the consumption of dietary protein from different sources in pre-pregnancy or/and during pregnancy and the risk of GDM were included. To combine effect sizes for the comparison between the highest and lowest categories of protein intake, a random effects model was utilized. Dose-response relationships were investigated using a 1-stage random-effects model.
RESULTS
8 observational studies were included in the systematic review and 5 prospective cohort studies in the meta-analysis, involving a total of 24,160 participants and 2450 cases of GDM. The analysis revealed a significant association between total protein intake during pregnancy and an elevated risk of GDM (relative risk (RR): 2.24, 95 % confidence interval (CI): 1.67-3.00, P = 0.000). Conversely, no significant association was found between total protein intake before pregnancy and the risk of GDM. Both animal protein intake before pregnancy (RR: 1.47, 95 % CI: 1.06-2.03, P = 0.021) and during pregnancy (RR; 2.31, 95 % CI: 1.43-3.73, P = 0.001) showed a significant association with GDM. Interestingly, there was no significant association between the consumption of plant protein both before and during pregnancy and the risk of GDM. Further analysis revealed that an additional 5 % energy from total protein and animal protein per day was associated with a 24 % and 32 % before and 114 % and 67 % increased risk of GDM during pregnancy respectively.
CONCLUSION
In conclusion, consumption of animal protein and total protein before pregnancy is associated with an increased risk of GDM, although the association is not significant for total protein. Conversely, plant protein intake is linked to a decreased risk of GDM, however, the results are not significant. The intake of any protein type (plant/animal/total) during pregnancy is associated with an elevated risk of GDM, with this association being statistically insignificant for plant protein. Further cohort studies are required to validate the findings presented in this study.
REGISTRATION
PROSPERO (CRD42023396215).
Topics: Female; Humans; Pregnancy; Diabetes, Gestational; Risk Factors; Animal Proteins, Dietary; Plant Proteins, Dietary
PubMed: 38320463
DOI: 10.1016/j.clnu.2024.01.027 -
BMC Nutrition Feb 2024Over the last decade, the results of several studies have indicated that adults' food preferences, consumption, and dietary choices vary depending on their genotype...
BACKGROUND
Over the last decade, the results of several studies have indicated that adults' food preferences, consumption, and dietary choices vary depending on their genotype characteristics. However, the results of studies related to genes and polymorphisms involved in this phenomenon are contradictory. This study is a systematic review designed to evaluate the genetic determinants of food preferences.
METHODS
This study was conducted following the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Searches were conducted to identify articles testing the impact of genotypes on food choices, preferences, and intake in healthy adults. The search included all relevant keywords, and studies published between 1/1/1994 and October 2022 were considered. We assessed the quality of included studies and evaluated the risk of bias using the Newcastle-Ottawa Scale (NOS) for observational studies.
RESULTS
A total of 8,510 records were identified through our search method, and finally, 50 studies were included in this study. The majority of the studies evaluated the association of genetic variants with preferences for macronutrients, sweet, bitter, and fatty foods. The results of our study suggest a significant correlation between TAS2R38 variants (rs713598, rs1726866, rs10246939) and bitter and sweet taste preferences. Additionally, we found a considerable association between the T102C polymorphism of the 5-HT2A receptor gene and a higher intake of protein, and rs1761667 (CD36) was associated with fat preference.
CONCLUSION
In conclusion, this study revealed a significant association between certain genetic variants and food preferences among adults.
PubMed: 38308303
DOI: 10.1186/s40795-024-00828-y -
Reviews on Recent Clinical Trials 2024Carob ( L.) has been widely cultivated in different parts of the world, particularly in the Mediterranean region, and the tree belongs to the family Leguminosae. Several...
Carob ( L.) has been widely cultivated in different parts of the world, particularly in the Mediterranean region, and the tree belongs to the family Leguminosae. Several studies have indicated that carobs and their products can improve human health and help prevent different specific chronic diseases. Carob can considered as functional food due to its high content in dietary fibers, low-fat content, and high content of minerals. Its fruit is a pod containing 10%-20% seeds, and the pods consist of sugars, proteins, crude fibers, minerals, vitamins, polyphenols, vitamins, and lipids. In many countries in the Middle east, carob is mainly used to prepare as a traditional drink and some kinds of confectioneries. The powders can be utilized to prepare carob juice concentrate. The systematic review of documents from clinical trials and scientific societies dedicated to traditional medicine in China has been carried out. The goal of this review article is a survey of chemical compounds, and pharmaceutical benefits of carob, especially by considering traditional medicinal sciences. Moreover, clinical trials research promotes studies to highlight and focus on the scope of application of traditional medicinal science in the growing system of medicine.
Topics: Humans; Fabaceae; Functional Food; Galactans; Mannans; Mediterranean Region; Phytochemicals; Plant Gums
PubMed: 38288801
DOI: 10.2174/0115748871278128240109074506 -
Methods in Molecular Biology (Clifton,... 2024An Adverse Outcome Pathway (AOP) is an analytical model that describes, through a graphical representation, a linear sequence of biologically connected events at...
An Adverse Outcome Pathway (AOP) is an analytical model that describes, through a graphical representation, a linear sequence of biologically connected events at different levels of biological organization, causally leading to an adverse effect on human health or the environment. In general, AOPs are constructed based on five central principles: systematic development and review, chemical-agnostic, modular, networks, and living documents. Furthermore, AOPs have the potential to be used, for example, to investigate certain molecular targets; relate the regulation of specific genes or proteins among AOPs; extrapolate biological processes, pathways, or diseases from one species to another; and even predict adverse effects in particular populations. AOPs also emerge as an alternative to animal experimentation in studies of developmental malformations. It's even possible now to develop a quantitative AOP to predict teratogenic effects for some substances. However, the construction of high-quality AOPs requires standardization in the way these models are developed and reviewed, ensuring an adequate degree of flexibility and guaranteeing efficiency. The development of AOPs should strictly be based on the guidance documents developed by the OECD. Nevertheless, an important step for those developing AOPs is the choice of an apical endpoint or an initiating molecular event in order to initiate the construction of the pathway. Another crucial step is a systematic literature review based on the random combination of the blocks of information. With these two fundamental steps completed, it only remains to follow the guidance documents on Developing and Assessing Adverse Outcome Pathways and AOP Developers' Handbook supplement provided by the OECD to organize and construct an AOP. This modern approach will bring radical changes in the field of toxicity testing, regarding the prediction of apical toxic effects using molecular-level effects.
Topics: Animals; Humans; Dietary Supplements; Drug-Related Side Effects and Adverse Reactions; Teratogenesis; Teratology; Animal Use Alternatives
PubMed: 38285337
DOI: 10.1007/978-1-0716-3625-1_6 -
Phytotherapy Research : PTR Mar 2024Anthocyanins, due to their antioxidant effects, are candidates to reduce inflammation and the risk of inflammatory diseases. Therefore, through conducting a systematic... (Meta-Analysis)
Meta-Analysis Review
Effects of purified anthocyanins supplementation on serum concentration of inflammatory mediators: A systematic review and dose-response meta-analysis on randomized clinical trials.
Anthocyanins, due to their antioxidant effects, are candidates to reduce inflammation and the risk of inflammatory diseases. Therefore, through conducting a systematic review and meta-analysis, we tried to find the effect of purified anthocyanins on serum levels of C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α). Databases including, ISI Web of Science, Scopus, ClinicalTrials.gov, PubMed, and Cochrane Library were searched up to June 2023. The meta-analysis was done by calculating mean differences and their standard deviations. Calculating the statistical heterogeneity of intervention effects was performed through I-squared statistics and Cochran's Q test. The pooled estimate showed a significant decrease in serum levels of CRP, TNF-α, and IL-6 (weighted mean difference (WMD) = -0.12 mg/L, 95% confidence interval (CI) = -0.21 to -0.02, p = 0.013; WMD = -1.37 pg/mL, 95% CI = -1.79 to -0.96; p < 0.001; WMD = -1.43 pg/mL, 95% CI = -1.87 to -1.00; p < 0.001, respectively). Subgroup analysis results revealed purified anthocyanins significantly decreased serum levels of CRP among participants with serum levels of CRP≥1.52 mg/L, at-risk/unhealthy status, and in trials with intervention duration ≥84 days, anthocyanins dose ≥320 mg/day, and sample size ≥85 subjects. Regarding TNF-α and IL-6, out results showed that there was a significant effect of purified anthocyanins on serum levels of TNF-α and IL-6 in most subgroups. The results of our study indicated that purified anthocyanins significantly decreased serum levels of CRP, TNF-α, and IL-6. However, further high-quality studies are needed to firmly establish the efficacy of purified anthocyanins.
Topics: Humans; Dietary Supplements; Anthocyanins; Interleukin-6; Tumor Necrosis Factor-alpha; Inflammation Mediators; Randomized Controlled Trials as Topic; Inflammation; C-Reactive Protein; Biomarkers
PubMed: 38272574
DOI: 10.1002/ptr.8124 -
Clinical Cardiology Jan 2024This meta-analysis aimed to evaluate the effects of flaxseed supplementation on weight loss, lipid profiles, high-sensitivity C-reactive protein (hs-CRP), and glucose... (Meta-Analysis)
Meta-Analysis Review
Effects of flaxseed supplementation on weight loss, lipid profiles, glucose, and high-sensitivity C-reactive protein in patients with coronary artery disease: A systematic review and meta-analysis of randomized controlled trials.
This meta-analysis aimed to evaluate the effects of flaxseed supplementation on weight loss, lipid profiles, high-sensitivity C-reactive protein (hs-CRP), and glucose levels in patients with coronary artery disease (CAD). A systematic search was performed using various online databases, including Scopus, PubMed, Web of Science, EMBASE, and Cochrane Library, to identify relevant randomized controlled trials (RCTs) until June 2023. To evaluate heterogeneity among the selected studies, the Q-test and I statistics were employed. Data were combined using either a fixed- or random-effects model and presented as a weighted mean difference (WMD) with a 95% confidence interval (CI). Of the 428 citations, six RCTs were included. The pooled results did not show significant changes in the WMD of lipid factors (high-density lipoprotein cholesterol, triglycerides (TG), low-density lipoprotein cholesterol, and total cholesterol) following flaxseed intake. However, after performing a sensitivity analysis to determine the source of heterogeneity, flaxseed supplementation resulted in a significant decrease in TG levels (WMD = -18.39 mg/dL; 95% CI: -35.02, -1.75). Moreover, no significant differences were observed in either weight or BMI following flaxseed intake. However, the circulating levels of fasting blood glucose (WMD = -8.35 mg/dL; 95% CI: -15.01, -1.69, p = .01) and hs-CRP (WMD = -1.35 mg/L; 95% CI: -1.93, -0.77, p < .01) significantly decreased after the intervention. Flaxseed supplementation was associated with lowering FBS, hs-CRP, and TG levels but did not affect weight loss parameters and other lipid markers in CAD.
Topics: Humans; Coronary Artery Disease; C-Reactive Protein; Flax; Glucose; Randomized Controlled Trials as Topic; Cholesterol, HDL; Weight Loss; Dietary Supplements
PubMed: 38269632
DOI: 10.1002/clc.24211 -
International Journal of Molecular... Jan 2024Alzheimer's Disease (AD) is the most common neurodegenerative disease which manifests with progressive cognitive impairment, leading to dementia. Considering the... (Meta-Analysis)
Meta-Analysis Review
Alzheimer's Disease (AD) is the most common neurodegenerative disease which manifests with progressive cognitive impairment, leading to dementia. Considering the noninvasive collection of saliva, we designed the systematic review to answer the question "Are salivary biomarkers reliable for the diagnosis of Alzheimer's Disease?" Following the inclusion and exclusion criteria, 30 studies were included in this systematic review (according to the PRISMA statement guidelines). Potential biomarkers include mainly proteins, metabolites and even miRNAs. Based on meta-analysis, in AD patients, salivary levels of beta-amyloid42 and p-tau levels were significantly increased, and t-tau and lactoferrin were decreased at borderline statistical significance. However, according to pooled AUC, lactoferrin and beta-amyloid42 showed a significant predictive value for salivary-based AD diagnosis. In conclusion, potential markers such as beta-amyloid42, tau and lactoferrin can be detected in the saliva of AD patients, which could reliably support the early diagnosis of this neurodegenerative disease.
Topics: Humans; Alzheimer Disease; Neurodegenerative Diseases; Lactoferrin; MicroRNAs; Biomarkers
PubMed: 38256241
DOI: 10.3390/ijms25021168 -
Food & Function Feb 2024: A large number of recent studies have reported on the use of antioxidants in patients with polycystic ovary syndrome (PCOS). This study aimed to evaluate the... (Meta-Analysis)
Meta-Analysis Review
: A large number of recent studies have reported on the use of antioxidants in patients with polycystic ovary syndrome (PCOS). This study aimed to evaluate the antioxidant effects on PCOS. : We searched PubMed, Embase, Web of Science, and The Cochrane Library to identify randomized controlled trials investigating the use of antioxidants in treating PCOS. Statistical analysis was performed using Review Manager 5.4. Stata17.0 software was used to conduct sensitivity analyses. : This meta-analysis included 49 articles and 62 studies. The sample comprised 1657 patients with PCOS from the antioxidant group and 1619 with PCOS from the placebo group. The meta-analysis revealed that the fasting blood glucose levels [standardized mean difference (SMD): -0.31, 95% confidence interval (CI): -0.39 to -0.22, < 0.00001], the homeostatic model assessment of insulin resistance (SMD: -0.68, 95% CI: -0.87 to -0.50], < 0.00001), and insulin levels (SMD: -0.68, 95% CI: -0.79 to -0.58, < 0.00001) were significantly lower in patients with PCOS taking antioxidants than those in the placebo group. Further, total cholesterol levels (SMD: -0.38, 95% CI: -0.56 to -0.20, < 0.001), low-density lipoprotein cholesterol levels (SMD: -0.24, 95% CI: -0.37 to -0.10, = 0.0008), and very low-density lipoprotein levels (SMD: -0.53, 95% CI: -0.65 to -0.41, < 0.00001) were lower in patients with PCOS taking antioxidant supplements compared with the placebo group. Total testosterone (TT) level (SMD: -0.78, 95% CI: -1.15 to -0.42, < 0.0001), dehydroepiandrosterone level (SMD: -0.42, 95% CI: -0.58 to -0.25, < 0.00001), and mean standard deviation modified Ferriman-Gallway (MF-G scores) (SMD: -0.63, 95% CI: -0.98 to -0.28, = 0.0004) were lower in patients taking antioxidant supplements. C-reactive protein (CRP) levels (SMD: -0.48, 95% CI: -0.63 to -0.34, < 0.000001), body mass index [mean difference (MD): -0.27, 95% CI: -0.50 to -0.03, = 0.03], weight (MD: -0.73, 95% CI: -1.35 to -0.11, = 0.02), and diastolic blood pressure (MD: -3.78, 95% CI: -6.30 to -1.26, = 0.003) were significantly lower. Moreover, the levels of sex hormone-binding protein (SMD: 0.23, 95% CI: 0.07-0.38, = 0.004), high-density lipoprotein cholesterol (SMD: 0.11, 95% CI: 0.01-0.20, = 0.03), total antioxidant capacity (SMD: 0.59, 95% CI: 0.31-0.87, < 0.0001), and quantitative insulin sensitivity index (SMD: 0.01, 95% CI: 0.01-0.02, < 0.00001) were higher in patients with PCOS who took antioxidant supplements compared with the placebo group. Antioxidant supplements did not affect other analyzed parameters in these patients, including follicle-stimulating hormone, free androgen index, nitric oxide, glutathione, malondialdehyde, and diastolic blood pressure. : Antioxidants are beneficial in treating PCOS. Our study might provide a new treatment strategy for patients with clinical PCOS. We hope that more high-quality studies evaluating the effects of antioxidants on patients with PCOS will be conducted in the future. : https://www.crd.york.ac.uk/prospero/, identifier CRD42023448088.
Topics: Female; Humans; Antioxidants; Polycystic Ovary Syndrome; Dietary Supplements; Lipoproteins, LDL; Cholesterol
PubMed: 38251706
DOI: 10.1039/d3fo02824k