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1.
A multimodal nutritional intervention after discharge improves quality of life and physical function in older patients - a randomized controlled trial.
Munk, T, Svendsen, JA, Knudsen, AW, Østergaard, TB, Thomsen, T, Olesen, SS, Rasmussen, HH, Beck, AM
Clinical nutrition (Edinburgh, Scotland). 2021;(11):5500-5510
Abstract
BACKGROUND Many older hospitalized patients are at nutritional risk or malnourished and the nutritional condition is often further impaired during hospitalization. When discharged to own home, a "Nutrition Gap" often occurs, causing inadequate dietary intake, and potentially impeded recovery. Previously, cross-sectorial studies of single component nutritional intervention have shown a limited effect on clinically relevant outcomes. We hypothesized that a multimodal nutritional intervention is necessary to elicit a beneficial effect on clinically relevant outcomes. METHODS A randomized controlled trial was performed for a period of 16 weeks. At discharge, the intervention group (IG) received dietetic counselling including a recommendation of daily training, an individual nutrition plan and a package containing foods and drinks covering dietary requirements for the next 24 h. Further, a goodie-bag containing samples of protein-rich milk-based drinks were provided. Information regarding recommendations of nutritional therapy after discharge was systematically and electronically communicated to the municipality. The dietician performed telephone follow-ups on day 4 and 30 and a home visit at 16 weeks. The control group (CG) received standard treatment. The primary outcome was readmissions within 6 month, secondary outcomes were Length of Stay (LOS), Health Related Quality of Life (EQ-5D-3L), nutritional status, physical function (30s-CST) and mortality. This trial was registered under ClinicalTrials.gov Identifier no. NCT03488329. RESULTS We included 191 patients (IG: n = 93). No significant difference was seen in readmissions within 6 month (IG: 45% vs. CG: 45%, Risk Ratio (RR): 0.96 0.71-1.31, p = 0.885). At the 16-weeks follow-up more patients in the IG reached at least 75% of energy and protein requirements (82% vs. CG: 61%, p = 0,007). The energy (kcal) and protein intake (g) per kg was significantly higher in the IG (26.4 kcal/kg (±7.4) vs. 22.6 (±7.4), p = 0.0248) (1.1 g/kg (±0.3) vs. 0.9 g/kg (±0.3). Furthermore, significant lower weight loss was seen in IG (0.7 (±4.3) vs. -1.4 (±3.6), p = 0.002). A significant and clinically relevant difference was found in the EQ-5D-3L VAS-score (IG: mean 61.6 ± 16.2 vs. CG: 53.3 ± 19.3, p = 0.011) (Δ14.3 (±15.5) vs. Δ5.6 (±17.2), p = 0.002). A significant difference in mean 30s-CST in IG was also found (7.2 (±4.3) vs. 5.3 (±4.1), p = 0.010). The improvements in physical function were of clinical relevance in both groups, but significantly higher in the IG (Δ4.2 (±4.4) vs. Δ2.2 (±2.5), p = 0.008). In fact, 86% in IG experienced improvements in the 30s-CST compared with 68% in the CG (p = 0.022). LOS was found to be lower at all time points, however not significant (30 days: -3 (-8.5 to 2.5), p = 0.276, 16 weeks: -4 (-10.2 to 2.2, p = 0.204), 6 months: -3 (-9.3 to 3.3, p = 0346)). All-cause mortality was not different between groups, however RR showed a non-significantly 47% reduction at day 30 (0.53 (0.14-2.05, p = 0.499)) and a 17% reduction at 16 weeks (0.83 (0.40-1.73, p = 1.000)) in IG. Per protocol (PP) analysis revealed a non-significant decrease of 32% in readmission at 6 months (RR: 0.68 (0.42-1.08), p = 0.105). CONCLUSION The present study, using a multimodal nutritional approach, revealed no significant effect on readmissions however a significant positive effect on nutritional status, quality of life and physical function was found. The improvements in quality of life and physical function were of clinical relevance. No significant effect was found on LOS and mortality.
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2.
Oral Nutritional Supplementation Improves Growth in Children at Malnutrition Risk and with Picky Eating Behaviors.
Khanna, D, Yalawar, M, Saibaba, PV, Bhatnagar, S, Ghosh, A, Jog, P, Khadilkar, AV, Kishore, B, Paruchuri, AK, Pote, PD, et al
Nutrients. 2021;(10)
Abstract
The problem of poor nutrition with impaired growth persists in young children worldwide, including in India, where wasting occurs in 20% of urban children (<5 years). Exacerbating this problem, some children are described by their parent as a picky eater with behaviors such as eating limited food and unwillingness to try new foods. Timely intervention can help prevent nutritional decline and promote growth recovery; oral nutritional supplements (ONS) and dietary counseling (DC) are commonly used. The present study aimed to determine the effects of ONS along with DC on growth in comparison with the effects of DC only. Enrolled children (N = 321) were >24 to ≤48 months old, at malnutrition risk (weight-for-height percentile 3rd to 15th), and described as a picky eater by their parent. Enrollees were randomized to one of the three groups (N = 107 per group): ONS1 + DC; ONS2 + DC; and DC only. From day 1 to day 90, study findings showed significant increases in weight-for-height percentile for ONS1 + DC and for ONS2 + DC interventions, as compared to DC only (p = 0.0086 for both). There was no significant difference between the two ONS groups. Anthropometric measurements (weight and body mass index) also increased significantly over time for the two ONS groups (versus DC only, p < 0.05), while ONS1 + DC significantly improved mid-upper-arm circumference (p < 0.05 versus DC only), as well. ONS groups showed a trend toward greater height gain when compared to DC only group, but the differences were not significant within the study interval. For young Indian children with nutritional risk and picky eating behaviors, our findings showed that a 90-day nutritional intervention with either ONS1 or ONS2, along with DC, promoted catch-up growth more effectively than did DC alone.
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3.
A novel intervention combining supplementary food and infection control measures to improve birth outcomes in undernourished pregnant women in Sierra Leone: A randomized, controlled clinical effectiveness trial.
Hendrixson, DT, Smith, K, Lasowski, P, Callaghan-Gillespie, M, Weber, J, Papathakis, P, Iversen, PO, Koroma, AS, Manary, MJ
PLoS medicine. 2021;(9):e1003618
Abstract
BACKGROUND Innovations for undernourished pregnant women that improve newborn survival and anthropometry are needed to achieve the Sustainable Development Goals 1 and 3. This study tested the hypothesis that a combination of a nutritious supplementary food and several proven chemotherapeutic interventions to control common infections would increase newborn weight and length in undernourished pregnant women. METHODS AND FINDINGS This was a prospective, randomized, controlled clinical effectiveness trial of a ready-to-use supplementary food (RUSF) plus anti-infective therapies compared to standard therapy in undernourished pregnant women in rural Sierra Leone. Women with a mid-upper arm circumference (MUAC) ≤23.0 cm presenting for antenatal care at one of 43 government health clinics in Western Rural Area and Pujehun districts were eligible for participation. Standard of care included a blended corn/soy flour and intermittent preventive treatment for malaria in pregnancy (IPTp). The intervention replaced the blended flour with RUSF and added azithromycin and testing and treatment for vaginal dysbiosis. Since the study involved different foods and testing procedures for the intervention and control groups, no one except the authors conducting the data analyses were blinded. The primary outcome was birth length. Secondary outcomes included maternal weight gain, birth weight, and neonatal survival. Follow-up continued until 6 months postpartum. Modified intention to treat analyses was undertaken. Participants were enrolled and followed up from February 2017 until February 2020. Of the 1,489 women enrolled, 752 were allocated to the intervention and 737 to the standard of care. The median age of these women was 19.5 years, of which 42% were primigravid. Twenty-nine women receiving the intervention and 42 women receiving the standard of care were lost to follow-up before pregnancy outcomes were obtained. There were 687 singleton live births in the intervention group and 657 in the standard of care group. Newborns receiving the intervention were 0.3 cm longer (95% confidence interval (CI) 0.09 to 0.6; p = 0.007) and weighed 70 g more (95% CI 20 to 120; p = 0.005) than those receiving the standard of care. Those women receiving the intervention had greater weekly weight gain (mean difference 40 g; 95% CI 9.70 to 71.0, p = 0.010) than those receiving the standard of care. There were fewer neonatal deaths in the intervention (n = 13; 1.9%) than in the standard of care (n = 28; 4.3%) group (difference 2.4%; 95% CI 0.3 to 4.4), (HR 0.62 95% CI 0.41 to 0.94, p = 0.026). No differences in adverse events or symptoms between the groups was found, and no serious adverse events occurred. Key limitations of the study are lack of gestational age estimates and unblinded administration of the intervention. CONCLUSIONS In this study, we observed that the addition of RUSF, azithromycin, more frequent IPTp, and testing/treatment for vaginal dysbiosis in undernourished pregnant women resulted in modest improvements in anthropometric status of mother and child at birth, and a reduction in neonatal death. Implementation of this combined intervention in rural, equatorial Africa may well be an important, practical measure to reduce infant mortality in this context. TRIAL REGISTRATION ClinicalTrials.gov NCT03079388.
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4.
Impact of specialized oral nutritional supplement on clinical, nutritional, and functional outcomes: A randomized, placebo-controlled trial in community-dwelling older adults at risk of malnutrition.
Chew, STH, Tan, NC, Cheong, M, Oliver, J, Baggs, G, Choe, Y, How, CH, Chow, WL, Tan, CYL, Kwan, SC, et al
Clinical nutrition (Edinburgh, Scotland). 2021;(4):1879-1892
Abstract
BACKGROUND & AIMS The world's over-65 population is expanding rapidly, and the risk of malnutrition is prevalent in this population. Meeting nutritional needs is a recognized strategy to reduce and address multiple debilitating adverse health outcomes associated with malnutrition. The objective of this randomized, controlled trial was to determine the effects of oral nutritional supplement (ONS) containing beta-hydroxy-beta-methylbutyrate (HMB), along with dietary counseling, on health outcomes in community-dwelling older adults at risk of malnutrition. METHODS Strengthening Health In ELDerly through nutrition (SHIELD) studied adults aged ≥ 65 years in Singapore who were recruited between August 2017 and March 2019. Participants were community ambulant and classified as medium or high risk for malnutrition using Malnutrition Universal Screening Tool (MUST). Participants (n = 811) were randomly assigned to one of two study treatments for 180 days: (i) two servings/day of ONS containing HMB with dietary counseling (n = 405) or (ii) two servings/day of placebo supplement with dietary counseling (n = 406). The primary composite outcome was 'survival without hospital (re)admission and with at least 5% weight gain to day 180'. Dietary intakes, nutritional and functional outcomes were measured at baseline, 30, 90, and 180 days. RESULTS A higher proportion in intervention group met the 180-day primary composite outcome compared to placebo (33.4% vs. 8.7%, P < 0.001), largely driven by body weight component (36.2% vs. 9.4%, P < 0.001). Survival and hospital (re)admission rate were not significantly different between the groups. Weight, BMI, and mid upper arm circumference were significantly greater in the intervention group compared to placebo during the study (all P < 0.001), and at days 30, 90, and 180 (all P < 0.05). The odds of having better nutritional status during the study were also significantly higher in the intervention group compared to placebo, as measured using MUST risk (OR = 2.68, P < 0.001) and vitamin D status (OR = 4.23, P < 0.001). Intervention group had significantly higher energy, protein, fat, and carbohydrate intakes than the placebo group (all P ≤ 0.017). Leg strength at day 90 was significantly greater for the intervention group than for the placebo group (LSM ± SE: 12.85 ± 0.22 vs. 12.17 ± 0.22; P = 0.030). Handgrip strength for females was significantly higher at day 180 for the intervention group compared to placebo (LSM ± SE: 14.18 ± 0.17 vs. 13.70 ± 0.17; P = 0.048). Within the low appendicular skeletal muscle mass index (ASMI) subgroup, the intervention group had significantly greater calf circumference at days 90 and 180 compared to placebo (both P ≤ 0.0289). CONCLUSIONS For community-dwelling older adults at risk of malnutrition, daily consumption of specialized ONS containing HMB and vitamin D for six months, along with dietary counseling, significantly improved nutritional and functional outcomes compared to placebo supplement with dietary counseling. CLINICAL TRIAL REGISTRATION www.ClinicalTrials.govNCT03245047.
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5.
Effects of Home-Delivered Meals on Older People's Protein Intake, Physical Performance, and Health-Related Quality of Life: The Power Meals Randomized Controlled Trial.
Kunvik, S, Rautakallio-Järvinen, P, Laaksonen, M, Valve, R, Salonoja, M, Fogelholm, L, Suominen, MH
Journal of nutrition in gerontology and geriatrics. 2021;(2-3):125-149
Abstract
This trial examined the effectiveness of an 8-week home meal service on protein and other nutrient intake, physical performance (PP) and health related quality of life (HRQoL) among older people living at home (≥65 years; home care clients, caregivers and care recipients). Participants were randomized into three groups; (1) protein-rich meal, snack, and bread (INT1), (2) regular meal (INT2) and (3) control group. Nutrient intake was assessed with 3-day food diaries, PP with Short Physical Performance Battery (SBBP) and HRQoL with 15 dimensional Health-related quality of life instrument. Total of 67 (59.7% women, mean age 78.2 years) participants (n = 22 INT1, n = 24 INT2, n = 21 CG) completed the trial. At baseline, mean protein intake was 0.92 (SD 0.32) g/kg adjusted body weight (aBW)/d. At 8 weeks, protein-rich home meal service in INT1 increased protein intake (+ 0.11 (95%CI -0.01 to 0.21) g/kg aBW/d, 9.4 (95%CI 1.0 to 17.8) g/d) compared to other groups. It also increased calcium intake (+169.9 (95%CI 26 to 314) mg/d) and improved results in Sit-to-Stand Test (-4.8 (95%CI -6.8 to -2.7) sec) in INT1 compared to CG. Both home meal services increased saturated fat intake (INT1; 4.6 (95%CI 1.0-8.2) g/d, INT2;7.8 (95%CI 1.9 to 13.7)g/d) and decreased salt intake (INT1;-2330.9 (95%CI -2998 to -1664) mg/d, INT2; -2371.9 (95%CI -3399 to -1345) mg/d) compared to CG. There was no effect on overall HRQoL.
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Effectiveness of renal-specific oral nutritional supplements compared with diet counseling in malnourished hemodialysis patients.
Limwannata, P, Satirapoj, B, Chotsriluecha, S, Thimachai, P, Supasyndh, O
International urology and nephrology. 2021;(8):1675-1687
Abstract
BACKGROUND Malnutrition is highly prevalent and a consequence of inflammation and related comorbidities among patients on maintenance hemodialysis. Oral nutritional supplementation (ONS) is recommended for malnourished patients with kidney failure. The study aimed to evaluate renal-specific oral nutrition (ONCE dialyze) supplement on nutritional status in patients on hemodialysis. METHODS Patients were randomized into 3 groups; treatment groups received 370 kcal/day of ONCE Dialyze (N = 26) or 370 kcal/day of NEPRO (N = 30) for 30 days. The control group (N = 24) received no intervention. All patients were counseled by the same registered dietitian during the study. The nutritional status was evaluated using malnutrition inflammation score (MIS) assessment, body compositions, serum albumin and pre-albumin levels at baseline and 30 days. RESULTS Eighty patients were analyzed with mean age of 57.2 ± 15.9 years. The intervention group exhibited significant improvements in energy, protein, fat, fiber and magnesium intake by dietary interview compared with the control group. Percentage of changes in MIS was - 29.0% (95% CI - 40.5 to - 17.4), - 23.9% (95% CI - 37.2 to - 10.6) and 12.1% (95% CI - 19.2 to 43.4) for the ONCE dialyze, NEPRO and control groups, respectively (overall P = 0.006). Percentage of changes in serum albumin was 5.3% (95% CI 1.9-8.7), 3.3% (95% CI - 0.1 to 6.7) and - 0.8% (95% CI - 4.3 to 2.7) for the ONCE dialyze, NEPRO, and control groups, respectively (overall P = 0.039; P = 0.043 for ONCE dialyze vs. control). No serious adverse effects were reported in any group. CONCLUSION Dietary advice combined with ONS especially ONCE dialyze was associated with improved MIS, serum albumin, dietary energy and macronutrient intake among patients with kidney failure on maintenance hemodialysis. CLINICAL TRIAL REGISTRATION TCTR20200801001.
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The Impact of Human Papillomavirus (HPV) Associated Oropharyngeal Squamous Cell Carcinoma (OPSCC) on Nutritional Outcomes.
Harrowfield, J, Isenring, E, Kiss, N, Laing, E, Lipson-Smith, R, Britton, B
Nutrients. 2021;(2)
Abstract
Patients undergoing (chemo) radiotherapy for oropharyngeal squamous cell carcinoma (OPSCC) are at high risk of malnutrition during and after treatment. Malnutrition can lead to poor tolerance to treatment, treatment interruptions, poor quality of life (QOL) and potentially reduced survival rate. Human papillomavirus (HPV) is now known as the major cause of OPSCC. However, research regarding its effect on nutritional outcomes is limited. The aim of this study was to examine the relationship between HPV status and nutritional outcomes, including malnutrition and weight loss during and after patients' (chemo) radiotherapy treatment for OPSCC. Methods: This was a longitudinal cohort study comparing the nutritional outcomes of HPV-positive and negative OPSCC patients undergoing (chemo) radiotherapy. The primary outcome was nutritional status as measured using the Patient Generated-Subjective Global Assessment (PG-SGA). Secondary outcomes included loss of weight, depression, QOL and adverse events. Results: Although HPV-positive were less likely to be malnourished according to PG-SGA at the beginning of treatment, we found that the difference between malnutrition rates in response to treatment was not significantly different over the course of radiotherapy and 3 months post treatment. HPV-positive participants had significantly higher odds of experiencing >10% weight loss at three months post-treatment than HPV-negative participants (OR = 49.68, 95% CI (2.7, 912.86) p ≤ 0.01). Conclusions: The nutritional status of HPV positive and negative patients were both negatively affected by treatment and require similarly intense nutritional intervention. In acute recovery, HPV positive patients may require more intense intervention. At 3- months post treatment, both groups still showed nutritional symptoms that require nutritional intervention so ongoing nutritional support is essential.
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8.
Effect of a newly developed ready-to-use supplementary food on growth indicators in children with mild to moderate malnutrition.
Azimi, F, Esmaillzadeh, A, Alipoor, E, Moslemi, M, Yaseri, M, Hosseinzadeh-Attar, MJ
Public health. 2020;:290-297
Abstract
OBJECTIVES Malnutrition is one of the leading causes of death among children younger than five years. In this study, we aimed to formulate a ready-to-use supplementary food (RUSF), based on local food products, and investigate its efficacy on growth indicators in children with mild to moderate malnutrition. STUDY DESIGN This is a randomized controlled clinical trial. METHODS This study was performed in six health centers in Shahr-e-Rey, Tehran, Iran, between April and October 2017. One hundred children, aged 24-59 months, with mild to moderate malnutrition (weight-for-height Z-score [WHZ] between -3 and -1) were randomly assigned to two groups to receive either 1-3 sachets of RUSF or normal diet for 8 weeks. All mothers and caregivers received nutrition education. Growth indicators including weight and height, WHZ, and body mass index (BMI), along with clinical outcomes, were assessed. RESULTS Children who received RUSF had a significant increase in weight (1.44 ± 0.38 vs 0.7 ± 0.32 kg, respectively, P < 0.001), and BMI (1.2 ± 0.47 vs 0.35 ± 0.33 kg/m2, respectively, P < 0.001) compared with the control group. There was a greater daily weight gain during the first 4 weeks (P < 0.001) and throughout the study (P = 0.013) in the RUSF group. Daily height gain was considerably higher in the RUSF group during the first 4 weeks (P = 0.027). Children in the RUSF group had more improvement in WHZ (1.18 ± 0.41 vs 0.41 ± 0.31, P < 0.001) after supplementation. Besides, 92% of the RUSF and 12% of the control group reached to WHZ > -1 at the end of the study (P < 0.001). There was lower prevalence of diarrhea (12% vs 28.6%, respectively, P = 0.01) and marginally lower fever (16% vs 36.7%, respectively, P = 0.05) in the intervention than in the control group. CONCLUSIONS A newly developed RUSF improved growth indicators and clinical outcomes in children with mild to moderate malnutrition. CLINICAL TRIAL REGISTRY NUMBER IRCT2017021315536N6 (registered at www.irct.ir).
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Individualized nutritional treatment for acute stroke patients with malnutrition risk improves functional independence measurement: A randomized controlled trial.
Otsuki, I, Himuro, N, Tatsumi, H, Mori, M, Niiya, Y, Kumeta, Y, Yamakage, M
Geriatrics & gerontology international. 2020;(3):176-182
Abstract
AIM: The aim of the present study was to investigate the effects of individualized nutritional treatment on the activities of daily living of acute stroke patients. METHODS This was a randomized controlled study. The eligibility criteria were acute stroke, age >65 years and the presence of malnutrition risk. Between September 2016 and December 2017, 128 patients were assigned to either the standard or intensive group (individualized nutritional treatment). The intensive group received energy that was calculated using the Harris-Benedict equation. The main outcome measures were the total functional independence measurement gain from the time of assignment to the time of discharge from the recovery hospital or at 3 months after the stroke onset, and motor and cognitive functional independence measurement gains. RESULTS Compared with the standard group, the intensive group had significantly higher median energy intake (P < 0.001); significantly greater functional independence measurement gains in the total score (42 vs. 22; P = 0.02) and motor subscore (P = 0.01), but similar cognitive subscore. CONCLUSION Individualized nutritional treatment improved the activities of daily living of older acute stroke patients with malnutrition risk. Geriatr Gerontol Int 2019; ••: ••-••.
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Accelerated rehabilitation combined with enteral nutrition in the management of lung cancer surgery patients.
Ding, Q, Chen, W, Gu, Y, Qi, ZY, Chen, YH, Chen, J, Jiang, L
Asia Pacific journal of clinical nutrition. 2020;(2):274-279
Abstract
BACKGROUND AND OBJECTIVES To investigate the effect of accelerated rehabilitation combined with enteral nutrition on surgically treated lung cancer patients. METHODS AND STUDY DESIGN In total, 150 lung cancer patients treated in our hospital from January 2017 to January 2018 were retrospectively analysed. Sixty-six patients were randomly divided into a control group with conventional nutrition (Con group) and an accelerated rehabilitation combined with enteral nutrition group (EN group). Postoperative drainage; total hospitalization time; total hospitalization expenses; and albumin, haemoglobin and total lymphocyte counts (TLC) before and after treatment were compared. RESULTS The serum albumin, prealbumin and haemoglobin in both groups were decreased after operation and were significantly higher in the EN group (p<0.05) than in the Con group. The TLC decreased in both groups after operation and were significantly higher in the EN group than in the con group. The postoperative drainage volume, total hospitalization time and total hospitalization expenses were significantly lower in the EN group than in the Con group (p<0.05). CONCLUSIONS The effect of accelerated rehabilitation combined with enteral nutrition in lung cancer surgery patients is clear. Surgery leads to stress, which enhances catabolism and reduces the synthesis of carbohydrates, protein, and fat, increasing patients' nutritional risk. Nutritional support combined with fast-track minimally invasive thoracic surgery for at-risk lung cancer patients who undergo preoperative nutritional screening and assessment can reduce postoperative complications and hospitalization time and improve nutritional indicators, immunity, respiratory function recovery and clinical outcomes, leading to socioeconomic benefits.