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Oral nutrition supplements and between-meal snacks for nutrition therapy in patients with COPD identified as at nutritional risk: a randomised feasibility trial.

ABSTRACT: Introduction:Intervention studies have mainly used oral nutritional supplements (ONS) for the management of patients with chronic obstructive pulmonary disease (COPD) identified as at nutritional risk. In this 12-month randomised feasibility trial, we assessed the (1) feasibility of the recruitment, retention and provision of two interventions: ONS and between-meal snacks (snacks) and (2) the potential impact of the provision of snacks and ONS on body weight and quality of life in patients with COPD. Methods:Hospitalised patients with COPD, at nutritional risk, were randomised to ONS (n=19) or snacks (n=15) providing 600 kcal and 22 g protein a day in addition to regular daily diet. The intervention started in hospital and was continued for 12 months after discharge from the hospital. Results:Study recruitment rate was n=34 (45%) and retention rate at 12 months was similar for both groups: n=13 (68%) in the ONS group and n=10 (67%) in the Snacks group. Both groups gained weight from baseline to 12 months (2.3±4.6 kg (p=0.060) in the ONS group and 4.4±6.4 kg (p=0.030) in the Snacks group). The St George's Respiratory Questionnaire total score improved from baseline to 12 months in both groups (score 3.9±11.0 (p=0.176) in the ONS group and score 8.9±14.1 (p=0.041) in the Snacks group). Discussion:In patients with COPD who are at nutritional risk snacks are at least as feasible and effective as ONS, however, adequately powered trials that take account of the difficulties in recruiting this patient group are required to confirm this effect.

SUBMITTER: Ingadottir AR

PROVIDER: S-EPMC6326325 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Oral nutrition supplements and between-meal snacks for nutrition therapy in patients with COPD identified as at nutritional risk: a randomised feasibility trial.

Ingadottir Arora Ros AR Beck Anne Marie AM Baldwin Christine C Weekes Christine Elizabeth CE Geirsdottir Olof Gudny OG Ramel Alfons A Gislason Thorarinn T Gunnarsdottir Ingibjorg I

BMJ open respiratory research 20190103 1

<h4>Introduction</h4>Intervention studies have mainly used oral nutritional supplements (ONS) for the management of patients with chronic obstructive pulmonary disease (COPD) identified as at nutritional risk. In this 12-month randomised feasibility trial, we assessed the (1) feasibility of the recruitment, retention and provision of two interventions: ONS and between-meal snacks (snacks) and (2) the potential impact of the provision of snacks and ONS on body weight and quality of life in patien ...[more]

PMID: 30687503

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Project description:Background: Ovarian cancer is the third most common gynecological malignancy in the world and it is under a higher incidence of malnutrition. Chemotherapy is currently a common treatment for ovarian cancer, but the resulting side effects can exacerbate malnutrition. Our aim was to investigate the beneficial effects of oral nutrition supplements (ONS) on ovarian cancer patients undergoing chemotherapy. Methods: Single-blinded randomized controlled trial. Patients with ovarian cancer receiving chemotherapy were randomly assigned either to the ONS or non-ONS groups via a simple randomization. The ONS group was given 250 mL ONS each time (1.06 kcal, 0.0356 g of protein per mL), three times a day, and nutrition education. Control group received nutrition education alone. The primary outcome was the nutritional risk of the patients as assessed by the Patient-Generated Subjective Global Assessment (PG-SGA). The secondary outcome was the results of the participants' biochemical tests at each measurement time point. Data were collected (T0) at baseline, (T1) post intervention at 3 weeks, (T2) 9-week follow-up, (T3) 15-week follow-up. Generalized estimating equation models were used to compare the changes in outcomes over time between groups. Results: 60 participants (30 ONS, 30 controls) completed the trial, and data was analyzed. For baseline comparisons, no significant differences were found between the two groups. A progressive trend toward amelioration in PG-SGA scores over time was found within the ONS group, with scores decreasing from 9.27 ± 1.68 at baseline (T0) to 5.87 ± 2.06 after the intervention (T3). Furthermore, ONS group achieved a significantly greater reduction in PG-SGA score at the T1 (p = 0.03, confidence interval -2.23 to -0.11), T2 (p = 0.001, confidence interval -2.86 to -0.74) and T3 (p < 0.001, confidence interval -3.81 to -1.53), than the control group. In terms of biochemical test results, patients in the ONS group had better leukocytes, lymphocytes, Hemoglobin, Albumin and Total Protein than the control group at different time points, with statistical differences between the two groups (p < 0.05). Conclusions: The present study demonstrated that ONS can significantly reduce the nutritional risk of patients undergoing chemotherapy for ovarian cancer. In addition, we also found that nutritional education seems to have a positive effect on reducing the nutritional risk of patients especially at the beginning of chemotherapy.

Project description:Children with or at risk of faltering growth require nutritional support and are often prescribed oral nutritional supplements (ONS). This randomised controlled trial investigated the effects of energy-dense paediatric ONS (2.4 kcal/ml, 125 ml: cONS) versus 1.5 kcal/ml, 200 ml ONS (sONS) in community-based paediatric patients requiring oral nutritional support. Fifty-one patients (mean age 5.8 years (SD 3)) with faltering growth and/or requiring ONS to meet their nutritional requirements were randomised to cONS (n?=?27) or sONS (n?=?24) for 28 days. Nutrient intake, growth, ONS compliance and acceptability, appetite and gastro-intestinal tolerance were assessed. Use of the cONS resulted in significantly greater mean total daily energy (+?531 kcal/day), protein (+?10.1 g/day) and key micronutrient intakes compared with the sONS group at day 28 and over time, due to high ONS compliance (81% of patients ??75%), maintained intake from diet alone and improved appetite in the cONS group, compared with the sONS group. Although growth increased in both intervention groups, results were significant in the cONS group (weight (p?=?0.007), height (p?<?0.001) and height z-score (p?=?0.006)).Conclusions: This study shows that use of energy-dense (2.4 kcal/ml) low-volume paediatric-specific ONS leads to improved nutrient intakes, growth and appetite in paediatric patients requiring oral nutrition support compared with standard energy density ONS.Trial registration: The trial is registered at clinicaltrials.gov , identification number NCT02419599. What is Known: • Faltering growth is the failure of children to achieve adequate growth at a normal rate for their age and requires nutritional support, including the use of oral nutritional supplements (ONS). • Energy-dense, low-volume ONS have benefits over standard ONS in adults. What is New: • This is the first RCT to investigate the effects of energy-dense, low-volume ONS (2.4 kcal/ml, 125 ml) in children with faltering growth, showing significant improvements in total nutrient intake and increased growth. • Energy-dense, low-volume ONS can play a key role in the management of faltering growth.

Project description:ObjectiveThere is limited evidence regarding the economic effects of nutrition support in cancer patients. This study aims at investigating the cost-effectiveness profile of systematic oral nutritional supplementation (ONS) in head and neck cancer (HNC) patients undergoing radiotherapy (RT) and receiving nutritional counseling.MethodsA cost-effectiveness analysis based on a RCT was performed to estimate direct medical costs, life years gained (LYG) and Quality-Adjusted Life Years (QALY) for nutritional counseling with or without ONS at 5-month and 6-year follow up time. Value of information analysis was performed to value the expected gain from reducing uncertainty through further data collection.ResultsONS with nutritional counseling produced higher QALY than nutritional counseling alone (0.291 ± 0.087 vs 0.288 ± 0.087), however the difference was not significant (0.0027, P = 0.84). Mean costs were €987.60 vs €996.09, respectively in the treatment and control group (-€8.96, P = 0.98). The Incremental Cost Effectiveness Ratio (ICER) was -€3,277/QALY, with 55.4% probabilities of being cost-effective at a cost-effectiveness threshold of €30,000/QALY. The Expected Incremental Benefit was €95.16 and the Population Expected Value of Perfect Information was €8.6 million, implying that additional research is likely to be worthwhile. At a median 6-year follow up, the treatment group had a significantly better survival rate when adjusting for late effect (P = 0.039).ConclusionOur findings provide the first evidence to inform decisions about funding and reimbursement of ONS in combination with nutritional counseling in HNC patients undergoing RT. ONS may improve quality of cancer care at no additional costs, however further research on the cost-effectiveness of nutritional supplementation is recommended.Trial registrationClinicalTrials.gov: NCT02055833. Registered 5th February 2014 https://clinicaltrials.gov/ct2/show/NCT02055833.

Dataset Information

Oral nutrition supplements and between-meal snacks for nutrition therapy in patients with COPD identified as at nutritional risk: a randomised feasibility trial.

Publications

Oral nutrition supplements and between-meal snacks for nutrition therapy in patients with COPD identified as at nutritional risk: a randomised feasibility trial.

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