Nutritional Intervention Studies Research Articles

A nutrition intervention study’s effect to hematology profiles on elderly group in social retirement home

The increase in the elderly brings consequences, including a higher risk of disease. Inappropriate nutritional intake is also known as one of the risk factors related to the elderly's non-communicable diseases, and nutritional intervention is essential to improve the elderly nutritional status and quality of life. It was an interventional study with a before-after one-group approach. The study was conducted for three months (October-December 2021) in three social retirement homes. The intervention given was supplementation with additional protein sources and snacks each day. The biochemistry profiles were taken 2 times: before and after three months of intervention, comprised of HbA1c, lipid, transferrin, creatinine, and blood pressure level. The data will be analyzed for its normality before being processed with paired t-test or Wilcoxon signed rank based on the normality results. The analysis results show that there are significantly lower transferrin levels (p=0.040), an increase in cholesterol level (p=0.000), and low-density lipoprotein (LDL) level increased from 114.05±32.03 to 125.94±31.41 (p=0.000). There is also a remarkable decrease in hemoglobin (p=0.005) and high-density lipoprotein (HDL) levels. Conversely, there are an increase in HbA1C (p=0.007) and triglyceride level (p=0.005). There is no significant difference in creatinine level. We conclude that nutrition interventions have a significant effect on elderly blood profiles. However, to achieve an improvement, the study should consider physical activity and other variables that might be altering the results.

Critical outcomes to be included in the Core Outcome Set for nutritional intervention studies in older adults with malnutrition or at risk of malnutrition: a modified Delphi Study.

As part of the development of an agreed minimum set of outcomes or Core Outcome Set (COS) for future nutritional intervention trials in older adults with malnutrition or at risk of malnutrition, this work reports on the Delphi surveys and final consensus. Outcomes from a scoping review were incorporated into a two-round Delphi survey. Researchers and healthcare professionals experienced in malnutrition in older adults were invited to take part in an online survey to rate 38 selected outcomes on a nine-point Likert scale ranging from 'not important' to 'critical' for their setting (community, hospital, or long-term care). Consensus for inclusion was reached when ≥75% (or ≥60% if a patient-reported outcome) of the participants scored the outcome as 'critical' and <15% as 'not important'. Resulting outcomes were voted for inclusion or exclusion in the COS in a final online consensus meeting. Ninety-three and 72 participants from diverse professional backgrounds and countries participated in the 1st and 2nd Delphi round, respectively. After both rounds eleven outcomes met the inclusion criteria, largely irrespective of setting. Fifteen participants, representing academia, health care, health policy, industry, and PPI, voted in a final online consensus meeting resulting in ten outcomes: malnutrition status, dietary intake, appetite, body weight or BMI, muscle strength, muscle mass, functional performance, functional limitations, quality of life, and acceptability of the intervention. Ten outcomes will form the COS which is intended to be used by the scientific community in all future nutritional intervention studies for older adults with malnutrition or at risk of malnutrition. The subsequent phase will establish the appropriate methods to measure these outcomes.

#2320 The impact of interventions for people with chronic kidney disease on health-related quality of life: a systematic review

Abstract Background and Aims Health-related quality of life (HRQoL) is poorer for those with chronic kidney disease (CKD) than the general population and worsens as CKD progresses. Evidence is mixed as to which interventions improve HRQoL for those with CKD, and HRQoL is often under-reported in randomised controlled trials where it is most commonly a secondary outcome. Reviews including HRQoL as an outcome have thus far focused on the impact per intervention, therefore we aimed to ascertain which interventions, of any type, have an impact on HRQoL outcomes for those with non-dialysis dependent CKD (NDD-CKD). Method The protocol was prospectively registered on PROSPERO (CRD42022364474) and PRISMA guidelines were followed. Inclusion criteria were randomised controlled trials in an NDD-CKD population (excluding transplant recipients), any intervention type, usual care/placebo comparators, using validated and reported HRQoL outcomes measures. Databases searched were Embase, Medline, PsychINFO, CINAHL plus, Web of Science, PubMed, and Google Scholar, with reference searching of included studies. Reports were independently screened by two researchers who also performed data extraction and quality assessment (using the Cochrane Risk of Bias 2.0 tool). Synthesis was undertaken using Synthesis without Meta-analysis (SWiM) methods. Conversion to one-sided p-values, synthesising outcomes in albatross plots and combining p-values via Fisher's method was performed using the metap package in R. HRQoL measures were broken down into physical, mental, kidney disease symptoms, adverse effects of kidney disease, burden of kidney disease, overall kidney disease, and overall HRQoL domains for analysis. Results Searches yielded 8983 records, and 39 studies met inclusion criteria, with a total of 11,940 participants. Nine groups were formed based on type of intervention, with data synthesis possible in the eight groups with more than one study (Fig. 1). 26 (66%) studies were rated as having high risk of bias, largely due to frequent lack of blinding and HRQoL being a patient reported outcome. 37 studies had sufficient data for presentation in albatross plots (Fig. 2). Using combined p-values for all HRQoL outcomes in each group of studies, benefit to HRQoL in at least one study was shown for education interventions (p &amp;lt; 0.001, seven studies, none with low risk of bias), exercise interventions (p &amp;lt; 0.001, eight studies, all with high risk of bias), medications to treat CKD-related anaemia (p &amp;lt; 0.001, eight studies, four with low risk of bias), nutritional interventions (p &amp;lt; 0.001, four studies, all with high risk of bias) and weight loss interventions (p &amp;lt; 0.001, two studies, one with low risk of bias). No benefit to HRQoL was shown for medications aimed at slowing CKD progression (p = 0.492, five studies), medications for depression (p = 0.266, two studies) and medications to treat acidosis (p = 0.99, two studies). Conclusion This review identified several interventions with evidence of benefit to HRQoL for people with NDD-CKD, including medications to treat anaemia and weight loss interventions. Studies of education, exercise and nutritional interventions showed potential benefit, but with high risk of bias. Further high-quality randomised controlled trials of interventions for people with NDD-CKD should include and report HRQoL outcomes, in addition to targeting potentially modifiable determinants of HRQoL in these groups.

Impact of increased protein intake in older adults: a 12-week double-blind randomised controlled trial.

Emerging evidence suggests health-promoting properties of increased protein intake. There is increased interest in plant protein but a dearth of information in relation to its impact on muscle function. The objective of the present work was to examine the impact of intake of different types of proteins on muscle functional parameters including handgrip strength, biomarkers of metabolic health, sleep quality and quality of life in a group of older adults. Healthy men and women aged 50years and older entered a double-blinded, randomised, controlled nutritional intervention study with three parallel arms: high plant protein, high dairy protein and low protein. Participants consumed once daily a ready-to-mix shake (containing 20g of protein in high protein groups) for 12weeks. Changes in handgrip and leg strength, body composition, metabolic health, quality of life and sleep quality were analysed by linear mixed models in an intention-to-treat approach. Eligible participants (n= 171) were randomly assigned to the groups (plant: n= 60, dairy: n= 56, low protein: n= 55) and 141 completed the study. Handgrip strength increased after the intervention (Ptime= 0.038), with no significant difference between the groups. There was no significant difference between groups for any other health outcomes. In a population of older adults, increasing protein intake by 20g daily for 12weeks (whether plant-based or dairy-based) did not result in significant differences in muscle function, body composition, metabolic health, sleep quality or quality of life, compared with the low protein group.

Effect of nutritional interventions on the psychological symptoms of premenstrual syndrome in women of reproductive age: a systematic review of randomized controlled trials.

Premenstrual syndrome (PMS) affects approximately 48% of women of reproductive age worldwide. It can lead to functional impairment, lower quality of life, and decreased work productivity. Despite the availability of medical treatment options, women are seeking alternative interventions because of concerns of harmful side effects and limited evidence of efficacy associated with pharmacological treatments. To date, high-quality research investigating the effects of dietary and nutrient intervention on PMS is limited. This systematic review investigated the effect of nutritional interventions on the psychological symptoms of PMS. Five electronic databases were searched for randomized controlled trials (RCTs) published in English from inception to October 2022. Trials eligible for inclusion were nutritional intervention studies involving women of reproductive age that measured PMS-associated psychological outcomes. Articles were selected using prespecified inclusion criteria. Data screening and extraction and risk-of-bias assessments were conducted by 3 independent reviewers using article screening software and the Cochrane Risk of Bias 2 tool. Thirty-two articles reporting on 31 RCTs involving 3254 participants, ranging in age from 15 to 50 years were included and narratively reviewed. Only 1 of the included studies had a low risk of bias. Treatment with vitamin B6, calcium, and zinc consistently had significant positive effects on the psychological symptoms of PMS. There was insufficient evidence to support the effects of vitamin B1, vitamin D, whole-grain carbohydrates, soy isoflavones, dietary fatty acids, magnesium, multivitamin supplementation, or PMS-specific diets. There is some evidence to support the use of nutritional interventions for improving psychological symptoms of PMS. However, more research using consistent protocols, procedures to minimize risk of bias, intention-to-treat analysis, and clearer reporting is required to provide conclusive nutritional recommendations for improving PMS-related psychological outcomes. CRD42022369999.

A Conceptual Study on Characterizing the Complexity of Nutritional Interventions for Malnourished Older Adults in Hospital Settings: An Umbrella Review Approach.

Malnutrition is a widespread and intricate issue among hospitalized adults, necessitating a wide variety of nutritional strategies to address its root causes and repercussions. The primary objective of this study is to systematically categorize nutritional interventions into simple or complex, based on their resource allocation, strategies employed, and predictors of intervention complexity in the context of adult malnutrition in hospital settings. A conceptual evaluation of 100 nutritional intervention studies for adult malnutrition was conducted based on data from a recent umbrella review (patient population of mean age > 60 years). The complexity of interventions was categorized using the Medical Research Council 2021 Framework for Complex Interventions. A logistic regression analysis was employed to recognize variables predicting the complexity of interventions. Interventions were divided into three principal categories: education and training (ET), exogenous nutrient provision (EN), and environment and services (ES). Most interventions (66%) addressed two or more of these areas. A majority of interventions were delivered in a hospital (n = 75) or a hospital-to-community setting (n = 25), with 64 studies being classified as complex interventions. The logistic regression analysis revealed three variables associated with intervention complexity: the number of strategies utilized, the targeted areas, and the involvement of healthcare professionals. Complex interventions were more likely to be tailored to individual needs and engage multiple healthcare providers. The study underlines the importance of considering intervention complexity in addressing adult malnutrition. Findings advocate for a comprehensive approach to characterizing and evaluating nutritional interventions in future research. Subsequent investigations should explore optimal balances between intervention complexity and resource allocation, and assess the effectiveness of complex interventions across various settings, while considering novel approaches like telehealth.

Informed Consent in the Workplace Nutrition Intervention Studies: A Narrative Review on Ethical Challenges

Workplace nutrition interventions are efforts to improve workers' health and well-being through education, counselling and environmental changes. Nutrition intervention studies are needed to evaluate the effectiveness of such programs and interventions. The aim of this study was to analyse studies on the importance and best practices of informed consent in workplace nutrition intervention studies and present the results in a narrative review. This study used qualitative research methods. The data collection technique in this research is by studying literature obtained from Google Scholar. The data collected was then analysed in three stages, namely data reduction, data presentation and drawing conclusions. The results showed that employees were fully aware of the nature of the intervention, its potential risks and benefits, and their right to withdraw from the study at any time7. This is important to respect employee autonomy and to ensure that research is conducted ethically. In conclusion, informed consent plays an important role in workplace nutrition intervention research. This not only protects the rights and welfare of employees but also contributes to the validity and ethical conduct of research.

Use of oral health care services among older home care clients in the context of an intervention study.

An increasing number of care-dependent older people living at home need external support to receive regular dental care. To investigate the use of oral health care services among old home care clients who participated in an intervention study focusing on oral self-care and nutrition. This study employed data from the multidisciplinary Nutrition, Oral Health and Medication (NutOrMed) intervention study with a population-based sample of 245 home care clients (74% female) aged 75 or more divided in intervention (n = 140) and two control groups (n = 105). The data were collected through interviews at baseline and 6-month follow-up. At baseline, 43% of participants reported visits to oral health care within the previous year. At 6-month follow-up, this proportion was 51%. In the intervention group, the corresponding figures were 46% and 53%, and in the controls 39% and 48%. Adjusted regression analyses showed that this change was statistically significant (p = 0.008). In addition, higher education and toothache or other discomfort related to teeth or dentures at baseline were associated with increased use after the 6-month follow-up (OR = 1.1, 95% CI = 1.0-1.2; OR = 3.4, 95% CI = 1.5-7.9) but being edentulous indicated the opposite (OR = 0.2, 95% CI = 0.1-0.4). Belonging to the intervention group was not associated with increased use. In older adults, any efforts to raise awareness of oral health are of great potential to increase use of services.

Efficacy of parsley seed-supplemented bread in improving serum osteopontin level and renal health in obese women: A nutritional intervention study

Obesity is a global epidemic and a major contributor to chronic kidney disease worldwide. This interventional study aimed to evaluate the effects of a unique parsley seed bread and a healthy balanced diet on serum osteopontin level and renal function in obese women. A total of 85 obese women (BMI, 35.68±0.47kg/m2) participated in an 8-week nutritional intervention comprising two phases. In the first phase, participants consumed 100g of ground parsley seed bread along with a healthy balanced low caloric regimen for four weeks. In the second phase, Baladi bread was substituted for the supplement, providing an equal caloric intake, for another four weeks. Relevant Anthropometric measurements, blood pressure, dietary recall, and biochemical parameters (osteopontin, IL-1β, IL-10, kidney functions, and lipid parameters) were assessed before and after each intervention phase. Following the initial intervention phase, there were significant improvements in all recorded mean anthropometric parameters (p≤0.001). Lipid parameters and risk factors also significantly decreased (p<0.05), while osteopontin, creatinine, and IL-1β levels decreased significantly. eGFR, creatinine clearance, IL-10 increased. However, these improved values returned to elevated levels after the omission of the supplement in the second phase. There was a significant negative correlation between osteopontin and creatinine, creatinine clearance, and IL-10. The combined effect of the novel parsley seed-based intervention and a healthy balanced low-calorie regimen demonstrated improvements in osteopontin level associated with renal disorders, and inflammation, in addition to dyslipidemia in obese women. This suggests a promising approach for improving and protecting kidney disorders.

Ramadan-specific nutrition education improves cardio-metabolic health and inflammation-a prospective nutrition intervention study from Pakistan.

There are recent reports that Ramadan fasting (RF) results in weight gain instead of weight loss. In addition, the data on the efficacy of brief nutrition education on healthy eating practices in Ramadan for better health are scarce. Therefore, a study was conducted to investigate the effects of brief nutrition education before the start of RF on healthy eating practices during RF. For this purpose, a prospective observational study focused on "Dietary Education and Awareness for Ramadan (DEAR)" as an intervention was carried out. The participants (n = 74) were recruited and divided into two groups, i.e., intervention and control groups (n = 37 each). As an intervention, nutrition education lessons were given before and during RF month. The control group did not attend these nutrition education lessons. Data on anthropometrics, dietary intake, and other parameters were collected at three time points: before, in the end, and 4 weeks after RF. Weight was measured in kg; height, waist circumference (WC), and hip circumference (HC) were measured in cm; and body mass index (BMI) was calculated. Waist-to-hip ratio (WHR) was calculated by dividing the waist value by the hip value. Body composition analysis was performed by the body composition analyzer (BF-907). Blood pressure (BP) was measured using a validated automated blood pressure. A 3-5 ml of venous blood was collected, and plasma and serum were separated. Serum and plasma samples were processed for general blood chemistry (blood lipid profile, glucose, and CRP) within 2 h. CRP was determined by the immunoturbidimetry method using an auto-analyzer. An enzyme-linked immunosorbent assay (ELISA) was used to determine cytokine/chemokines. Adherence to nutrition education (intervention) was assessed. The results show that nutrition education has positive effects on overall nutrition. Significant improvement in dietary adherence to dietary advice in the intervention group was noted. Significant BW loss (mean loss: 1.21 kg) in the intervention group was observed. The majority (63.3%) had lost BW ≥ 1.0 kg. Other changes observed as a result of the intervention included improvements in blood glucose, cholesterol, CRP levels, and systolic and diastolic BP. There was a notable shift in pro- and anti-inflammatory cytokine concentrations: IL-7, IL-4, and TGF-α decreased, while IL-2, TNF-α and resistin, IL-1 RA, IL-17 A, and sCD40 increased. In conclusion, RF resulted in a loss in mean BW and an improvement in related blood chemistry and cytokine profiles. Furthermore, nutrition education before RF resulted in better nutrition practices during RF and a desirable healthy BW, blood lipid, and cytokine profiles.

Quality of life measurement in nutrition intervention studies: A systematic review

Quality of life measurement in nutrition intervention studies: A systematic review

Regular protein supplement consumption proves feasible in advanced tumor patients participating in a multimodal nutrition and exercise intervention study

Regular protein supplement consumption proves feasible in advanced tumor patients participating in a multimodal nutrition and exercise intervention study

Determining critical outcomes for the core outcome set for nutrition intervention studies in older adults with malnutrition and at risk: A Delphi study

Determining critical outcomes for the core outcome set for nutrition intervention studies in older adults with malnutrition and at risk: A Delphi study

Size-controllable food-grade nanoparticles based on sea cucumber polypeptide with good anti-oxidative capacity to prolong lifespan in tumor-bearing mice

Liver cancer, a malignancy with a rising global incidence, poses a significant challenge in achieving effective treatment outcomes. As food-derived nutrient, sea cucumber peptide (SCP) has shown promising anticancer effects. Therefore, we explored the nanodelivery systems to encapsulate SCP to enhance its stability in the gastrointestinal tract and improve absorption within the tumor microenvironment. This study aimed to develop size-controllable multifunctional nanoparticles using SCP, procyanidins (PCs), and vanillin through molecular assembly via a one-pot Mannich condensation approach. These food-grade nanoparticles demonstrated water solubility and exhibited a spherical structure with sizes ranging from 441 to 1360 nm, depending on the concentration of the reactants. In vitro cell experiments demonstrated that SCP nanoparticles modified with PCs effectively reduced the generation of reactive oxygen species from H2O2 and acrylamide while maintaining normal levels of mitochondrial membrane potential. Furthermore, in vivo nutrition intervention studies conducted on tumor-bearing mice revealed that mice treated with SCP nanoparticles exhibited a survival rate of 40 %, which was significantly higher than the 0 % and 20 % survival rates observed in the control and SCP-treated groups, respectively. These findings suggest that SCP nanoparticles, possessing antioxidative properties and controllable sizes, hold potential for precision nutrition in the field of cancer treatment.

Defining a Continuous Glucose Baseline to assess the impact of nutritional interventions.

Accurate and robust estimation of individuals' basal glucose level is a crucial measure in nutrition research but is typically estimated from one or more morning fasting samples. The use of Continuous Glucose Monitoring (CGM) devices presents an opportunity to define more robust basal glucose levels, which estimates can be generalized to any time of the day. However, to date, no standardized method has been delineated. The current paper seeks to define a reliable algorithm to characterize the individual's basal glucose level over 24 h from CGM measurements. Data drawn from four nutritional intervention studies performed on adults free from chronic diseases were used to define that basal glucose levels were optimally estimated using the 40th percentile of the previous 24 h CGM data. This simple algorithm provides a Continuous Glucose Baseline over 24 h (24 h-CGB) that is an unbiased and highly correlated estimator (r = 0.86, p-value < 0.01) of standard fasting glucose. We conclude that 24-CGB can provide reliable basal glucose estimates across the day while being more robust to interference than standard fasting glucose, adaptable to evolving daily routines and providing useful reference values for free-living nutritional intervention research in non-diabetic individuals.

Analysis of high-dimensional metabolomics data with complex temporal dynamics using RM-ASCA.

The intricate dependency structure of biological "omics" data, particularly those originating from longitudinal intervention studies with frequently sampled repeated measurements renders the analysis of such data challenging. The high-dimensionality, inter-relatedness of multiple outcomes, and heterogeneity in the studied systems all add to the difficulty in deriving meaningful information. In addition, the subtle differences in dynamics often deemed meaningful in nutritional intervention studies can be particularly challenging to quantify. In this work we demonstrate the use of quantitative longitudinal models within the repeated-measures ANOVA simultaneous component analysis+ (RM-ASCA+) framework to capture the dynamics in frequently sampled longitudinal data with multivariate outcomes. We illustrate the use of linear mixed models with polynomial and spline basis expansion of the time variable within RM-ASCA+ in order to quantify non-linear dynamics in a simulation study as well as in a metabolomics data set. We show that the proposed approach presents a convenient and interpretable way to systematically quantify and summarize multivariate outcomes in longitudinal studies while accounting for proper within subject dependency structures.

The Pathways to Prevention program: nutrition as prevention for improved cancer outcomes.

Adequate nutrition is central to well-being and health and can enhance recovery during illness. Although it is well known that malnutrition, both undernutrition and overnutrition, poses an added challenge for patients with cancer diagnoses, it remains unclear when and how to intervene and if such nutritional interventions improve clinical outcomes. In July 2022, the National Institutes of Health convened a workshop to examine key questions, identify related knowledge gaps, and provide recommendations to advance understanding about the effects of nutritional interventions. Evidence presented at the workshop found substantial heterogeneity among published randomized clinical trials, with a majority rated as low quality and yielding mostly inconsistent results. Other research cited trials in limited populations that showed potential for nutritional interventions to reduce the adverse effects associated with malnutrition in people with cancer. After review of the relevant literature and expert presentations, an independent expert panel recommends baseline screening for malnutrition risk using a validated instrument following cancer diagnosis and repeated screening during and after treatment to monitor nutritional well-being. Those at risk of malnutrition should be referred to registered dietitians for more in-depth nutritional assessment and intervention. The panel emphasizes the need for further rigorous, well-defined nutritional intervention studies to evaluate the effects on symptoms and cancer-specific outcomes as well as effects of intentional weight loss before or during treatment in people with overweight or obesity. Finally, although data on intervention effectiveness are needed first, robust data collection during trials is recommended to assess cost-effectiveness and inform coverage and implementation decisions.

A ketogenic diet substantially reshapes the human metabolome

Western dietary habits (WD) have been shown to promote chronic inflammation, which favors the development of many of today's non-communicable diseases. Recently, ketogenic diets (KD) have emerged as an immune-regulating countermeasure for WD-induced metaflammation. To date, beneficial effects of KD have been solely attributed to the production and metabolism of ketone bodies. Given the drastic change in nutrient composition during KD, it is reasonable to assume that there are widespread changes in the human metabolome also contributing to the impact of KD on human immunity. The current study was conducted to gain insight into the changes of the human metabolic fingerprint associated with KD. This could allow to identify metabolites that may contribute to the overall positive effects on human immunity, but also help to recognize potential health risks of KD. We conducted a prospective nutritional intervention study enrolling 40 healthy volunteers to perform a three-week ad-libitum KD. Prior to the start and at the end of the nutritional intervention serum metabolites were quantified, untargeted mass spectrometric metabolome analyses and urine analyses of the tryptophan pathway were performed. KD led to a marked reduction of insulin (-21.45%±6.44%, p=0.0038) and c-peptide levels (-19.29%±5.45%, p=0.0002) without compromising fasting blood glucose. Serum triglyceride concentration decreased accordingly (-13.67%±5.77%, p=0.0247), whereas cholesterol parameters remained unchanged. LC-MS/MS-based untargeted metabolomic analyses revealed a profound shift of the human metabolism towards mitochondrial fatty acid oxidation, comprising highly elevated levels of free fatty acids and acylcarnitines. The serum amino acid (AA) composition was rearranged with lower abundance of glucogenic AA and an increase of BCAA. Furthermore, an increase of anti-inflammatory fatty acids eicosatetraenoic acid (p<0.0001) and docosahexaenoic acid (p=0.0002) was detected. Urine analyses confirmed higher utilization of carnitines, indicated by lower carnitine excretion (-62.61%±18.11%, p=0.0047) and revealed changes to the tryptophan pathway depicting reduced quinolinic acid (-13.46%±6.12%, p=0.0478) and elevated kynurenic acid concentrations (+10.70%±4.25%, p=0.0269). A KD fundamentally changes the human metabolome even after a short period of only three weeks. Besides a rapid metabolic switch to ketone body production and utilization, improved insulin and triglyceride levels and an increase in metabolites that mediate anti-inflammation and mitochondrial protection occurred. Importantly, no metabolic risk factors were identified. Thus, a ketogenic diet could be considered as a safe preventive and therapeutic immunometabolic tool in modern medicine. German Clinical Trials Register; DRKS-ID: DRKS00027992 (www.drks.de).

Editorial introductions.

Editorial introductions.

Effects of Nutritional Interventions in Older Adults with Malnutrition or at Risk of Malnutrition on Muscle Strength and Mortality: Results of Pooled Analyses of Individual Participant Data from Nine RCTs.

Nutritional intervention studies in older adults with malnutrition aim to improve nutritional status. Although these studies show a significant gain in body weight, there is inconsistent evidence of clinical effectiveness on muscle strength and mortality. This study aimed to examine the effects of nutritional interventions on muscle strength and risk of mortality in older adults (malnourished or at risk) and explore whether these effects are influenced by participant characteristics. Individual participant data were used from nine RCTs (community setting, hospital and long-term care; duration 12-24 weeks and included oral nutritional supplements, dietary counseling, or both). Handgrip strength (HGS) was measured in seven RCTs and six RCTs obtained mortality data. A ≥3 kg increase in HGS was considered clinically relevant. Logistic generalized estimating equations analyses (GEE) were used to test intervention effectiveness. GEE showed no overall treatment effect (OR 1.11, 95% CI 0.78-1.59) on HGS. A greater, but not statistically significant, effect on HGS was observed for older (>80 years) versus younger participants. No significant treatment effect was observed for mortality (OR 0.78, 95% CI 0.42-1.46). The treatment effect on mortality was greater but remained non-significant for women and those with higher baseline energy or protein intake. In conclusion, no effects of nutritional interventions were observed on HGS and mortality in older adults (malnourished or at risk). While the treatment effect was modified by some baseline participant characteristics, the treatment also lacked an effect in most subgroups.