Oral protein energy supplements for children with cystic fibrosis: CALICO multicentre randomised controlled trial. Failure of conventional strategies to improve nutritional status in malnourished adolescents and adults with cystic fibrosis. Protein-energy oral supplementation in malnourished nursing-home residents. A controlled trial. Relationships among nutritional status and skeletal and respiratory muscle function in cystic fibrosis: does early dietary supplementation make a difference? Three month intervention with protein and energy rich supplements improve muscle function and quality of life in malnourished patients with non-neoplastic gastrointestinal disease--a randomized controlled trial. Effect of calorie-protein supplementation on the cognitive recovery of patients with subacute stroke. Effects of oral nutritional supplements in normally nourished or mildly undernourished geriatric patients after surgery for hip fracture: a randomized clinical trial. Behavioral intervention to improve calorie intake of children with cystic fibrosis: treatment versus wait list control. Protein energy supplements in unwell elderly patients--a randomized controlled trial.
To determine whether oral protein energy supplements, used long term in children with cystic fibrosis who are moderately malnourished, improve nutritional and other outcomes.
                Multicentre randomised controlled trial.
                Seven specialist paediatric cystic fibrosis centres and their associated shared care clinics and seven smaller paediatric cystic fibrosis clinics.
                102 children with cystic fibrosis, aged between 2 and 15 years, who were moderately malnourished.
                Oral protein energy supplements in addition to usual dietary advice compared with dietary advice alone, for 12 months.
                Change in body mass index centile over one year.
                Use of supplements was not associated with a change in body mass index centile (mean difference 2.99 centile points, 95% confidence interval -2.70 to 8.68) or other nutritional and spirometric outcomes in this group of children.
                Long term use of oral protein energy supplements did not result in an improvement in nutritional status or other clinical outcomes in children with cystic fibrosis who were moderately malnourished. Oral protein energy supplements should not be regarded as an essential part of the management of this group of children.
                ISRCTN: 95744468. The use of oral dietary supplements was compared with dietary counseling in 13 malnourished patients (3 males, mean age 18.1 years) with cystic fibrosis. Energy intake and nutritional status were evaluated over 3 months. There was no significant change in energy intake or percent ideal body weight in either group. To validate a nutritional intervention programme for elderly people living in nursing homes.
                In a prospective, randomized, controlled study of 88 residents, we determined nutritional status at day 0 and day 60 using a record of dietary intake, anthropometry, hand-grip strength and mini-nutritional assessment. Dietary intake, grip strength and body weight were also recorded at day 30. We divided subjects into four groups according to their mini-nutritional assessment score. Those with a score 24 received no oral supplementation. Those at risk of malnutrition (with a score of 17-23.5) were randomized to oral supplementation. Those with a score <17 received oral supplementation. We recorded the amount of oral supplements consumed daily.
                Compliance with oral supplementation was good, and daily intake averaged about 400 kcal. The total energy intake on day 60 was significantly higher in both of the groups that received supplements. Following supplementation, most subjects at risk of malnutrition improved their mini-nutritional assessment score and increased their weight (by 1.4 +/- 0.5 kg). Neither the mini-nutritional assessment score nor weight improved in subjects at risk of malnutrition who did not receive supplements. Supplementation in the malnourished group resulted in a mean mini-nutritional assessment score increase (from 13.9 +/- 2.6 to 17.1 +/- 3.9) and a mean weight gain of 1.5 +/- 0.4 kg.
                Oral nutritional supplements are well accepted and result in increased daily protein and energy intake, body weight and nutritional status in most malnourished patients and in those at risk of malnutrition. Relationships among nutritional status and skeletal and respiratory muscle function were examined in 16 children with cystic fibrosis (CF) and mild lung disease (FEV1 95 +/- 16% predicted). Subjects were randomly assigned to receive (or not) noninvasive nutritional supplementation at 25% of normal energy recommendations for 6 mo. Skeletal muscle strength and power were similar to those of healthy children as were respiratory muscle strength and endurance. Stepwise-regression analysis indicated that changes in skeletal muscle strength and energy intake correlated significantly with growth [weight (kg) = 1.90 - 0.60 (Tanner Stage) + 0.49 (maximum voluntary strength (Nm) + 0.03 (energy intake, % RNI), r = 0.76, P < 0.05], though body composition, protein biochemistry, muscle power, respiratory muscle strength, and use of dietary supplements did not. Thus, changes in skeletal muscle strength may be a functional index of changes in nutritional status in CF. Dietary supplementation per se was not associated with functional improvement. Malnutrition is a common problem in patients with digestive disease and is associated with impaired outcome.
                We investigated the effect of a three-month post-hospital nutritional intervention with high protein and energy supplements on body composition, muscle function and quality of life (QoL) in malnourished GI patients.
                Eighty malnourished patients with benign digestive disease were randomized to receive either oral nutritional supplements (ONS) for three months in addition to dietary counselling (DC) (ONS patients) or only dietary counselling (DC patients).
                Nutritional status was determined with the subjective global assessment, body composition by bioelectrical impedance and anthropometry, muscle function with hand-grip strength and peak flow. QoL was assessed by the 36-item short-form questionnaire.
                Age, body cell mass (BCM), muscle function, gender distribution and QoL did not differ between ONS patients (n=38) and DC patients (n=42) at baseline. Body weight and BCM improved significantly in both groups after three months. However, hand-grip strength (26.1+/-11.3-31.5+/-10.1 kg, p<0.0001) and peak flow (329.2+/-124.0-388.9+/-108.4 l /min, p=0.004) improved only in the ONS patients and remained unchanged in the DC patients. Similarly, all eight scales of the QoL improved in the ONS patients compared with merely three in the DC patients. DC patients experienced significantly more readmissions (n=20) than ONS patients (n=10) during the study period (p=0.041).
                A three month intervention with high protein oral supplements improves outcome in malnourished patients with digestive disease in terms of functional status, QoL and rehospitalization. The objective of this study was to investigate whether protein-calorie supplementation may enhance the cognitive retrieval of patients with stroke.
                A randomized, double-blind, controlled pilot clinical trial was performed comparing diet and diet plus protein-calorie supplementation regimens. The subjects were 48 patients with subacute stroke (>or14 days from index event). Anthropometric and nutritional (3-day diary) variables, cognitive function (Mini-Mental State Examination; MMSE) were determined before and 21 days after randomization in control and daily supplemented group (formula providing 250 kcal + 20 g protein).
                At day 21 after starting the protocol, only the supplemented group significantly improved their performance to MMSE (log(10)MMSE +0.6+/-0.4 score; P=0.01 from baseline).
                Protein-calorie supplementation may enhance the recovery of cognitive function in subacute stroke patients. Oral nutritional supplements have been recommended after orthopedic surgery in geriatric patients to reduce postoperative complications. However, tolerability of supplements could be a limitation, and their universal use is not supported by the heterogeneity of previous studies, especially in patients without malnutrition.
                This study is a randomized, controlled, open, parallel, 3-arm clinical trial comparing supplementation with protein powder dissolved in liquids to aim at 36 g of protein per day, energy and protein supplements to aim at 37.6 g of protein and 500 kcal per day, or no intervention in normally nourished or mildly undernourished patients. Outcomes were serum albumin, prealbumin, retinol-binding globulin, and body mass index, among others. Postoperative complications were also recorded.
                Ninety patients aged 83.8 +/- 6.6 years were included. The mean ingested amount of supplements was 41.1% +/- 20.6% in the protein powder supplement group and 51.4% +/- 13.2% in the energy protein supplement group (t = 2.278, P = .027). Postoperative supplements had no effect on the nutrition status during in-hospital follow-up, as assessed by serum albumin (P = .251), prealbumin (P = .530), retinol-binding globulin (P = .552), or body mass index (P = .582). Multivariate analysis showed that length of hospital stay with an established complication until its resolution (beta = .230, P = .031), total hospital stay (beta = .450, P < .001), baseline body mass index (beta = .204, P = .045), and total daily ingested proteins per body weight (beta = .252, P = .018) were predictive variables on the change in serum albumin (R2 = 0.409, F = 11.246, P < .001).
                Oral nutritional supplements in normally nourished or only mildly undernourished geriatric patients with hip fracture submitted to surgery may be of interest for patients with postoperative complications and long hospital stays. Changes in calorie intake and weight gain were evaluated in five children with cystic fibrosis (CF) who received behavioral intervention and four children with CF who served as wait list controls. The behavioral intervention was a 6-week group treatment that provided nutritional education plus management strategies aimed at mealtime behaviors that parents find most problematic. The control group was identified prospectively and was evaluated on all dependent measures at the same points in time pre- and posttreatment as the intervention group. Difference scores on calorie intake and weight gain from pre- to posttreatment were compared between groups using t tests for independent samples. The behavioral intervention group increased their calorie intake by 1,032 calories per day, while the control group's intake increased only 244 calories per day from pre- to posttreatment [t(6) = 2.826, p = 0.03]. The intervention group also gained significantly more weight (1.7 kg) than the control group (0 kg) over the 6 weeks of treatment [t(7) = 2.588, p = 0.03] and demonstrated catchup growth for weight, as indicated by improved weight Z scores (-1.18 to -0.738). The control group showed a decline in weight Z scores over this same time period (-1.715 to -1.76). One month posttreatment, the intervention was replicated with two of the four children from the control group. Improved calorie intake and weight gain pre- to posttreatment were again found in these children. At 3- and 6-month follow-up study of children receiving intervention, maintenance of calorie intake and weight gain was confirmed. No changes were found on pulmonary functioning, resting energy expenditure, or activity level pre- to posttreatment. This form of early intervention appears to be promising in improving nutritional status and needs to be investigated over a longer period of time to evaluate the effects of treatment gains on the disease process. To determine whether oral protein energy supplements, prescribed during hospitalization to elderly medical admissions, affect nutritional status and if baseline nutritional state influences this status. We also considered the effects on mortality, length of hospital stay, functional recovery, and institutionalization.
                A prospective randomized controlled trial with no placebo. Consenting patients were stratified in 3 nutritional categories, and patients from each stratum were randomized into treatment or control. Observers were blinded to randomization. The participants were emergency admissions from home to a Medicine for the Elderly Unit in a Scottish hospital. The inclusion criteria were as follows: no known malignancy, the ability to swallow, and nonobesity (BMI < 75th percentile). The intervention was a prescription of 120 mL sip feed, 3 times daily (540 kcal, 22.5 g protein per day) throughout hospitalization, using the medicine prescription chart. The trial was powered to detect change in mean percentage weight. The following outcomes were also considered: anthropometry; mortality, length of hospital stay, functional recovery, and rates of institutionalization.
                Included in the trial were 381 patients. Nutritional supplementation was associated with significantly better energy intake (p = .001) and weight gain (p = .003) pooled across all nutritional categories. In the most poorly nourished patients, the intervention was associated with reduced mortality (5/34 versus 14/40, p < .05) and more patients improved functionally (17/25 versus 11/28, p < .04). Overall mortality results were 21/186 versus 33/195, odds ratio (OR) 0.62, 95% confidence interval (CI) 0.35, 1.13.
                Prescribing sip feed supplements in the medicine prescription chart during hospital stay reduces weight loss. Our data also support other evidence for a reduction in mortality noted in elderly patients on nutritional supplementation. There were suggestions of other clinical benefits.
Oral protein calorie supplements are widely used to improve the nutritional status of children with a number of chronic diseases. We identified a small number of studies assessing these products in children with cystic fibrosis, but were unable to draw any conclusions based on the limited data extracted. We recommend a series of large, randomised controlled trials be undertaken investigating the use of these products in children with different chronic diseases. Until further data are available, we suggest these products are used with caution.