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. A randomized controlled trial of a new behavioral home-based nutrition education program, "Eat Well with CF," in adults with cystic fibrosis. 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. Improvement of weight and fat-free mass with oral nutritional supplementation in patients with Alzheimer's disease at risk of malnutrition: a prospective randomized study. Physiologic effects of oral supplemental feeding in malnourished patients with chronic obstructive pulmonary disease. A randomized control study. Protein energy supplements in unwell elderly patients--a randomized controlled trial. Effects of oral nutritional supplements in normally nourished or mildly undernourished geriatric patients after surgery for hip fracture: a randomized clinical 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. Cystic fibrosis (CF) remains the most common genetically inherited disease in the white population and its prognosis is affected by nutritional status. Adults with the disease are now surviving longer and new strategies are required to ensure that they maintain optimal nutrition. This article reports preliminary data from a randomized controlled trial of a 10-week home-based behavioral nutrition intervention, "Eat Well with CF." Outcome measures of weight change over 6 and 12 months and changes in CF-specific nutrition knowledge score, self-efficacy score, reported dietary fat intake and health-related quality-of-life score were compared between the intervention group (n=34) and a standard care control group (n=34). The hypotheses to be tested were that adults with CF completing "Eat Well with CF" would have an improved nutritional status, improvement in specific nutrition knowledge, and an improvement in self-efficacy regarding their ability to cope with a special diet, compared to those receiving standard care. There were substantial improvements in the intervention group's specific CF nutrition knowledge score, self-efficacy score, and reported fat intake compared to control, but no substantial change in body mass index or health-related quality of life over time. Home-based nutrition education incorporating behavioral strategies can be an effective way to support adults with CF, enabling improvement in self-management skills in relation to diet and pancreatic enzyme replacement therapy. This study revealed gaps in basic nutrition knowledge and skills, inadequate knowledge of diet-disease links and pancreatic enzyme replacement therapy. These need to be identified when subjects progress from pediatric to adult care, and programs such as "Eat Well with CF" are a useful adjunct for registered dietitians trying to manage this diverse but growing population. 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. To study the effects of oral nutritional supplements (OS) on body weight, body composition, nutritional status, and cognition in elderly patients with Alzheimer's disease (AD).
                Prospective, randomized, controlled study.
                Geriatric wards and day care centers in the Toulouse area, France.
                Ninety-one subjects with AD aged 65 and older at risk of undernutrition as evaluated using the Mini Nutritional Assessment.
                After randomization, 46 patients (intervention group) received 3-month OS. The other 45 patients (control group) received usual care.
                Weight, body composition (evaluated using dual-energy x-ray absorptiometry), cognitive function, activities of daily living, eating behavior, and dietary intakes were evaluated at the beginning of the study and at 3 months and 6 months. Supplement compliance was recorded each day.
                Between baseline and 3 months, energy and protein intakes significantly improved in the intervention group, resulting in a significant increase in weight and fat-free mass, but no significant changes were found for dependence, cognitive function, or biological markers. The nutritional benefit was maintained in the intervention group after discontinuation of OS at 3 months.
                Three-month daily OS significantly improves body weight. It is practicable and effective, and the patients accepted it well. The improvement that was observed even in the control group showed that caregiver education is an important factor in maintaining the nutritional status of patients with AD. Moreover, regular courses of OS may help to maintain the increase in fat-free mass and improve the nutritional status of these patients. The association between severe nutritional depletion and chronic obstructive pulmonary disease (COPD) has long been recognized. A potential therapeutic benefit to nutritional support was previously suggested by us in a pilot investigation. Subsequent studies have reported conflicting results regarding the role of nutritional therapy in this clinical population. We report a randomized controlled study of nutritional therapy in underweight patients with COPD that combines an initial inpatient investigation (controlled nutritional support) with a prolonged outpatient follow-up interval. Provision of adequate calorie and protein support, adjusted to metabolic requirements, resulted in weight gain (intervention = +2.4 kg versus control -0.5 kg), improved handgrip strength (intervention = +5.5 kg-force versus control -6.0 kg-force), expiratory muscle strength (intervention = +14.9 cm H2O versus control -9.2 cm H2O), and walking distance (intervention = +429 feet versus control -1.0 foot). Inspiratory muscle strength was also improved (intervention = +11.4 cm H2O versus control +4.8 cm H2O) although this did not quite reach statistical significance. We conclude that provision of adequate nutrient supply under controlled conditions results in significant clinical improvements in the COPD patient population. However, the intervention is costly, time-intensive, and of limited therapeutic magnitude. More detailed work of alternative outpatient strategies combined with additional rehabilitative measures is indicated to delineate the full therapeutic potential of nutritional support for this clinical population. 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 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.
Oral calorie supplements do not confer any additional benefit in the nutritional management of moderately malnourished children with CF over and above the use of dietary advice and monitoring alone. While nutritional supplements may be used, they should not be regarded as essential. Further randomised controlled trials are needed to establish the role of short-term oral protein energy supplements in people with CF and acute weight loss and also for the long-term nutritional management of adults with CF or advanced lung disease, or both.