Effect of the omega-3 fatty acid plus vitamin E supplementation on subjective global assessment score, glucose metabolism, and lipid concentrations in chronic hemodialysis patients.

SCOPE: This study was conducted to determine the effects of omega-3 fatty acid plus vitamin E supplementation on subjective global assessment (SGA) score and metabolic profiles in chronic hemodialysis (HD) patients. METHODS AND RESULTS: This randomized double-blind placebo-controlled clinical trial was conducted among 120 chronic HD patients. Participants were randomly divided into four groups to receive: (i) 1250 mg/day omega-3 fatty acid containing 600 mg eicosapentaenoic acid and 300 mg docosahexaenoic acid + vitamin E placebo (n = 30), (ii) 400 IU/day vitamin E + omega-3 fatty acids placebo (n = 30), (iii) 1250 mg omega-3 fatty acids/day + 400 IU/day vitamin E (n = 30), and (iv) omega-3 fatty acids placebo + vitamin E placebo (n = 30) for 12 wk. Fasting blood samples were taken at baseline and after 12-wk intervention to measure metabolic profiles. Patients who received combined omega-3 fatty acids and vitamin E supplements compared with vitamin E, omega-3 fatty acids, and placebo had significantly decreased SGA score (p < 0.001), fasting plasma glucose (p = 0.01), serum insulin levels (p = 0.001), homeostasis model of assessment insulin resistance (p = 0.002), and improved quantitative insulin sensitivity check index (p = 0.006). CONCLUSION: Omega-3 fatty acids plus vitamin E supplementation for 12 wk among HD patients had beneficial effects on SGA score and metabolic profiles.

Biochemical markers for assessment of calcium economy and bone metabolism: application in clinical trials from pharmaceutical agents to nutritional products.

Nutrition plays an important role in osteoporosis prevention and treatment. Substantial progress in both laboratory analyses and clinical use of biochemical markers has modified the strategy of anti-osteoporotic drug development. The present review examines the use of biochemical markers in clinical research aimed at characterising the influence of foods or nutrients on bone metabolism. The two types of markers are: (i) specific hormonal factors related to bone; and (ii) bone turnover markers (BTM) that reflect bone cell metabolism. Of the former, vitamin D metabolites, parathyroid hormone, and insulin-like growth factor-I indicate responses to variations in the supply of bone-related nutrients, such as vitamin D, Ca, inorganic phosphate and protein. Thus modification in bone remodelling, the key process upon which both pharmaceutical agents and nutrients exert their anti-catabolic or anabolic actions, is revealed. Circulating BTM reflect either osteoclastic resorption or osteoblastic formation. Intervention with pharmacological agents showed that early changes in BTM predicted bone loss and subsequent osteoporotic fracture risk. New trials have documented the influence of nutrition on bone-tropic hormonal factors and BTM in adults, including situations of body-weight change, such as anorexia nervosa, and weight loss by obese subjects. In osteoporosis-prevention studies involving dietary manipulation, randomised cross-over trials are best suited to evaluate influences on bone metabolism, and insight into effects on bone metabolism may be gained within a relatively short time when biochemical markers are monitored.

Deworming drugs for soil-transmitted intestinal worms in children: effects on nutritional indicators, haemoglobin and school performance.

BACKGROUND: The World Health Organization (WHO) recommends treating all school children at regular intervals with deworming drugs in areas where helminth infection is common. The WHO state this will improve nutritional status, haemoglobin, and cognition and thus will improve health, intellect, and school attendance. Consequently, it is claimed that school performance will improve, child mortality will decline, and economic productivity will increase. Given the important health and societal benefits attributed to this intervention, we sought to determine whether they are based on reliable evidence. OBJECTIVES: To summarize the effects of giving deworming drugs to children to treat soil-transmitted intestinal worms (nematode geohelminths) on weight, haemoglobin, and cognition; and the evidence of impact on physical well being, school attendance, school performance, and mortality. SEARCH METHODS: In February 2012, we searched the Cochrane Infectious Diseases Group Specialized Register, MEDLINE, EMBASE, LILACS, mRCT, and reference lists, and registers of ongoing and completed trials. SELECTION CRITERIA: We selected randomized controlled trials (RCTs) and quasi-RCTs comparing deworming drugs for geohelminth worms with placebo or no treatment in children aged 16 years or less, reporting on weight, haemoglobin, and formal test of intellectual development. In cluster-RCTs treating communities or schools, we also sought data on school attendance, school performance, and mortality. We included trials that included health education with deworming. DATA COLLECTION AND ANALYSIS: At least two authors independently assessed the trials, evaluated risk of bias, and extracted data. Continuous data were analysed using the mean difference (MD) with 95% confidence intervals (CI). Where data were missing, we contacted trial authors. We used GRADE to assess evidence quality, and this is reflected in the wording we used: high quality ("deworming improves...."); moderate quality ("deworming probably improves..."); low quality ("deworming may improve...."); and very low quality ("we don't know if deworming improves...."). MAIN RESULTS: We identified 42 trials, including eight cluster trials, that met the inclusion criteria. Excluding one trial where data are awaited, the 41 trials include 65,168 participants.Screening then treatingFor children known to be infected with worms (by screening), a single dose of deworming drugs may increase weight (0.58 kg, 95% CI 0.40 to 0.76, three trials, 139 participants; low quality evidence) and may increase haemoglobin (0.37 g/dL, 95% CI 0.1 to 0.64, two trials, 108 participants; low quality evidence), but we do not know if there is an effect on cognitive functioning (two trials, very low quality evidence).Single dose deworming for all childrenIn trials treating all children, a single dose of deworming drugs gave mixed effects on weight, with no effects evident in seven trials, but large effects in two (nine trials, 3058 participants, very low quality evidence). The two trials with a positive effect were from the same very high prevalence setting and may not be easily generalised elsewhere. Single dose deworming probably made little or no effect on haemoglobin (mean difference (MD) 0.06 g/dL, 95% CI -0.06 to 0.17, three trials, 1005 participants; moderate evidence), and may have little or no effect on cognition (two trials, low quality evidence).Mulitple dose deworming for all childrenOver the first year of follow up, multiple doses of deworming drugs given to all children may have little or no effect on weight (MD 0.06 kg, 95% CI -0.17 to 0.30; seven trials, 2460 participants; low quality evidence); haemoglobin, (mean 0.01 g/dL lower; 95% CI 0.14 lower to 0.13 higher; four trials, 807 participants; low quality evidence); cognition (three trials, 30,571 participants, low quality evidence); or school attendance (4% higher attendance; 95% CI -6 to 14; two trials, 30,243 participants; low quality evidence);For time periods beyond a year, there were five trials with weight measures. One cluster-RCT of 3712 children in a low prevalence area showed a large effect (average gain of 0.98 kg), whilst the other four trials did not show an effect, including a cluster-RCT of 27,995 children in a moderate prevalence area (five trials, 37,306 participants; low quality evidence). For height, we are uncertain whether there is an effect of deworming (-0.26 cm; 95% CI -0.84 to 0.31, three trials, 6652 participants; very low quality evidence). Deworming may have little or no effect on haemoglobin (0.00 g/dL, 95%CI -0.08 to 0.08, two trials, 1365 participants, low quality evidence); cognition (two trials, 3720 participants; moderate quality evidence). For school attendance, we are uncertain if there is an effect (mean attendance 5% higher, 95% CI -0.5 to 10.5, approximately 20,000 participants, very low quality evidence).Stratified analysis to seek subgroup effects into low, medium and high helminth endemicity areas did not demonstrate any pattern of effect. In a sensitivity analysis that only included trials with adequate allocation concealment, we detected no significant effects for any primary outcomes.One million children were randomized in a deworming trial from India with mortality as the primary outcome. This was completed in 2005 but the authors have not published the results. AUTHORS' CONCLUSIONS: Screening children for intestinal helminths and then treating infected children appears promising, but the evidence base is small. Routine deworming drugs given to school children has been more extensively investigated, and has not shown benefit on weight in most studies, except for substantial weight changes in three trials conducted 15 years ago or more. Two of these trials were carried out in the same high prevalence setting. For haemoglobin and cognition, community deworming seems to have little or no effect, and the evidence in relation to school attendance, and school performance is generally poor, with no obvious or consistent effect. Our interpretation of this data is that it is probably misleading to justify contemporary deworming programmes based on evidence of consistent benefit on nutrition, haemoglobin, school attendance or school performance as there is simply insufficient reliable information to know whether this is so.

Deworming drugs for soil-transmitted intestinal worms in children: effects on nutritional indicators, haemoglobin and school performance.

BACKGROUND: The World Health Organization (WHO) recommends treating all school children at regular intervals with deworming drugs in areas where helminth infection is common. The WHO state this will improve nutritional status, haemoglobin, and cognition and thus will improve health, intellect, and school attendance. Consequently, it is claimed that school performance will improve, child mortality will decline, and economic productivity will increase. Given the important health and societal benefits attributed to this intervention, we sought to determine whether they are based on reliable evidence. OBJECTIVES: To summarize the effects of giving deworming drugs to children to treat soil-transmitted intestinal worms (nematode geohelminths) on weight, haemoglobin, and cognition; and the evidence of impact on physical well being, school attendance, school performance, and mortality. SEARCH METHODS: In February 2012, we searched the Cochrane Infectious Diseases Group Specialized Register, MEDLINE, EMBASE, LILACS, mRCT, and reference lists, and registers of ongoing and completed trials. SELECTION CRITERIA: We selected randomized controlled trials (RCTs) and quasi-RCTs comparing deworming drugs for geohelminth worms with placebo or no treatment in children aged 16 years or less, reporting on weight, haemoglobin, and formal test of intellectual development. In cluster-RCTs treating communities or schools, we also sought data on school attendance, school performance, and mortality. We included trials that included health education with deworming. DATA COLLECTION AND ANALYSIS: At least two authors independently assessed the trials, evaluated risk of bias, and extracted data. Continuous data were analysed using the mean difference (MD) with 95% confidence intervals (CI). Where data were missing, we contacted trial authors. We used GRADE to assess evidence quality, and this is reflected in the wording we used: high quality ("deworming improves...."); moderate quality ("deworming probably improves..."); low quality ("deworming may improve...."); and very low quality ("we don't know if deworming improves...."). MAIN RESULTS: We identified 42 trials, including eight cluster trials, that met the inclusion criteria. Excluding one trial where data are awaited, the 41 trials include 65,168 participants.For programmes that treat only children detected as infected (by screening), a single dose of deworming drugs probably increased weight (0.58 kg, 95% CI 0.40 to 0.76, three trials, 139 participants; moderate quality evidence) and may have increased haemoglobin (0.37 g/dL, 95% CI 0.1 to 0.64, two trials, 108 participants; low quality evidence), but we do not know if there is an effect on cognitive functioning (two trials, very low quality evidence).For a single dose of deworming drugs given to all children in endemic areas, there were mixed effects on weight, with no effects evident in seven trials, but large effects in two. Overall our analysis indicated that we are uncertain whether there was an effect on weight (nine trials, 3058 participants; very low quality evidence). For haemoglobin, deworming made little or no difference (0.02 g/dL, 95% CI -0.05 to 0.09, four trials, 1992 participants; low quality evidence), and we don't know if it improves cognition (one trial, very low quality evidence).For multiple doses of deworming drugs with follow up for up to one year given to all children in endemic areas, we are uncertain if there is an effect on weight (0.06 kg, 95% CI -0.17 to 0.30; seven trials, 2460 participants; very low quality evidence); cognition (three trials, very low quality evidence); or school attendance (4% higher attendance; 95% CI -6 to 14; two trials, 75 clusters and 143 individually randomized participants, very low quality evidence). For haemoglobin, the intervention may have little or no effect (mean 0.01 g/dL lower; 95% CI 0.14 lower to 0.13 higher; four trials, 807 participants; low quality evidence).For multiple doses of deworming drugs with follow up beyond one year given to all children in endemic areas there were five trials with weight measures. One cluster-RCT of 3712 children in a low prevalence area showed a large effect (average gain of 0.98kg), whilst the other four trials did not show an effect, including a cluster-RCT of 27,995 children in a moderate prevalence area. Overall, we are uncertain if there is an effect for weight (five trials, 302 clusters and 1045 individually randomized participants; very low quality evidence). For other outcomes, we are uncertain whether deworming affects height (-0.26 cm; 95%CI -0.84 to 0.31, three trials, 1219 participants); haemoglobin (0.02 g/dL, 95%CI 0.3 to 0.27, two trials, 1365 participants); cognition (two trials), or school attendance (mean attendance 5% higher, 95% CI -0.5 to 10.5, one trial, 50 clusters).Stratified analysis to seek subgroup effects into low, medium and high helminth endemicity areas did not demonstrate any pattern of effect. We did not detect any significant effects for any primary outcomes in a sensitivity analysis only including trials with adequate allocation concealment.One million children were randomized in a deworming trial from India with mortality as the primary outcome. This was completed in 2005 but the authors have not published the results. AUTHORS' CONCLUSIONS: Screening children for intestinal helminths and then treating infected children appears promising, but the evidence base is small. Routine deworming drugs given to school children has been more extensively investigated, and has not shown benefit on weight in most studies, except for substantial weight changes in three trials conducted 15 years ago or more. Two of these trials were carried out in the same high prevalence setting. For haemoglobin, community deworming seems to have little or no effect, and the evidence in relation to cognition, school attendance, and school performance is generally poor, with no obvious or consistent effect. Our interpretation of this data is that it is probably misleading to justify contemporary deworming programmes based on evidence of consistent benefit on nutrition, haemoglobin, school attendance or school performance as there is simply insufficient reliable information to know whether this is so.

Assessment of zinc deficiency and effect of dietary carrot, amchur and onion on zinc status during repletion in zinc-deficient rats.

BACKGROUND: Food acidulants, ß-carotene-rich vegetables and sulfur compound-rich Allium spices are known to improve zinc bioaccessibility from food grains. This animal study evaluated the positive influence of these promoters of zinc bioaccessibility on zinc status during zinc repletion in Wistar rats previously rendered zinc-deficient by feeding a zinc-deficient semi-synthetic diet for 4 weeks. Groups of these zinc-deficient animals were subsequently maintained on a zinc-containing grain-based diet for 2 weeks. Various experimental diets consisted of the grain-based diet supplemented with (1) carrot, (2) onion, (3) amchur, (4) carrot + amchur and (5) onion + amchur. RESULTS: Zinc deficiency was confirmed by lower zinc concentration in tissues and bones and lower activity of zinc-containing enzymes. Zinc concentration was 10-15% lower in serum, liver and kidney of zinc-deficient rats. Bone weight in zinc-deficient rats was 20% lower than that in normal rats. Activities of zinc-containing enzymes (hepatic superoxide dismutase and alcohol dehydrogenase and serum alkaline phosphatase) were lower in the zinc-deficient group. Animals fed diets supplemented with these promoters of zinc bioaccessibility showed better zinc status in tissues and bones compared with those repleted with the control stock diet. CONCLUSION: This animal study supports the claim of promoters of zinc bioaccessibility for improving zinc status, which may find practical application.

Methods of assessment of copper status in humans: a systematic review.

BACKGROUND: The assessment of dietary adequacy of copper is constrained by the absence of recognized copper status biomarkers. OBJECTIVES: The objectives were to systematically review the usefulness of copper status biomarkers and identify those that reflected changes in status over > or =4 wk. DESIGN: The methods included a structured search on Ovid MEDLINE, EMBASE (Ovid), and Cochrane databases to October 2007, followed by the use of formal inclusion/exclusion criteria, data extraction, validity assessment, and meta-analysis. RESULTS: A total of 16 studies (288 participants) were included in the review, with data on 16 possible copper biomarkers. All of the included studies were small and at high risk of bias. Data for serum copper suggested its value as a biomarker, reflecting changes in status in both depleted and replete individuals, although these changes were smaller in the latter. Total ceruloplasmin protein is related to copper status but reflects changes in highly depleted individuals only. Erythrocyte superoxide dismutase and urinary deoxypyridinoline are not useful biomarkers, but there were insufficient data to draw firm conclusions about plasma, erythrocyte, and platelet copper; leukocyte superoxide dismutase; erythrocyte, platelet, and plasma glutathione peroxidase; platelet and leukocyte cytochrome-c oxidase; total glutathione; diamine oxidase; and urinary pyridinoline. The paucity of data prevented detailed subgroup analysis. CONCLUSIONS: Despite limited data, serum copper appears to be a useful biomarker of copper status at the population level. Further large studies with low risk of bias are needed to explore the effectiveness of other biomarkers of copper status and the relation between biomarker responsiveness, dose, and period of supplementation.

[Effectiveness of weekly iron supplementation on hemoglobin concentration, nutritional status and development of infants of public daycare centers in Recife, Pernambuco State, Brazil]. / Efetividade da suplementação semanal com ferro sobre a concentração de hemoglobina, estado nutricional e o desenvolvimento de lactentes em creches do Recife, Pernambuco, Brasil.

This study analyzed the effectiveness of weekly iron supplementation on hemoglobin concentration, nutritional status, and mental and motor development of infants at four public daycare centers in Recife, Pernambuco State, Brazil. This was a before-after intervention study conducted with weekly iron supplementation for six months in a sample of 76 infants in the 4 to 24 month age group, from February to December 2005. Mental and motor development was assessed through the Bayley Scale of Infant Development II. After supplementation, a significant increase was observed in hemoglobin concentration in the group of infants with initial hemoglobin level < or = 9.5g/dL (p = 0.001). There was also a significant increase in the mean weight-for-length z-score, but the opposite was found for length-for-age. No difference was observed in the developmental indices. We conclude that weekly iron supplementation was effective for increasing hemoglobin concentration in infants with lower initial levels, but no impact on infant development was observed.

Efetividade da suplementação semanal com ferro sobre a concentração de hemoglobina, estado nutricional e o desenvolvimento de lactentes em creches do Recife, Pernambuco, Brasil / Effectiveness of weekly iron supplementation on hemoglobin concentration, nutritional status and development of infants of public daycare centers in Recife, Pernambuco State, Brazil

Esse estudo teve como objetivo investigar a efetividade da suplementação semanal de ferro na concentração de hemoglobina, no estado nutricional e no desenvolvimento mental e motor de lactentes em quatro creches municipais do Recife, Pernambuco, Brasil. O estudo consistiu de uma intervenção do tipo antes-depois realizada com suplementação semanal com ferro por seis meses, em uma amostra de 76 crianças com idade entre 4 e 24 meses, no período de fevereiro a dezembro de 2005. Os desenvolvimentos mental e motor foram avaliados pela Escala de Desenvolvimento Infantil de Bayley II. Após a suplementação observou-se um aumento significante na concentração de hemoglobina, apenas no grupo de lactentes com hemoglobina inicial < 9,5g/dL (p = 0,001). Para o índice peso/comprimento também se verificou um incremento significante da média de escore z, no entanto, ocorreu o oposto para o índice comprimento/idade. Não se observou diferença nos índices de desenvolvimento. Conclui-se que a suplementação semanal de ferro foi efetiva elevando a hemoglobina nos lactentes com níveis iniciais mais baixos, não se observando impacto no desenvolvimento infantil.

This study analyzed the effectiveness of weekly iron supplementation on hemoglobin concentration, nutritional status, and mental and motor development of infants at four public daycare centers in Recife, Pernambuco State, Brazil. This was a before-after intervention study conducted with weekly iron supplementation for six months in a sample of 76 infants in the 4 to 24 month age group, from February to December 2005. Mental and motor development was assessed through the Bayley Scale of Infant Development II. After supplementation, a significant increase was observed in hemoglobin concentration in the group of infants with initial hemoglobin level < 9.5g/dL (p = 0.001). There was also a significant increase in the mean weight-for-length z-score, but the opposite was found for length-for-age. No difference was observed in the developmental indices. We conclude that weekly iron supplementation was effective for increasing hemoglobin concentration in infants with lower initial levels, but no impact on infant development was observed.

Improved effect of school meals with micronutrient supplementation and deworming.

A mid-day meal or school lunch program commenced in Gujarat, India from the sixties. In 1994, it was serving approximately 3 million schoolchildren. In 1994, the program was improved with the addition of a "package" of health inputs, including anthelmintics and micronutrient supplementation of iron and vitamin A, and iodine fortified salt. Tara Consultancy Services (TCS), India, a member of the Partnership of Child Development, Oxford University, evaluated Gujarat's improved midday meal program from 1993 to 1996. The program was implemented by the Commissionerate of the mid-day meal program, part of the government of Gujarat. The cost of the 'health package' in 1994, per child per year was 35 U.S. cents (1 U.S. dollars = Rs.30). The study to evaluate the improved program included the following components: FOCUS GROUP DISCUSSIONS: Government officials, teachers, students, parents, and community members participated in focus groups to elicit opinions on the proposed program which were predominantly positive. PROCESS EVALUATION: Logistical delivery defined as the adequacy, timeliness and cost of procurement of the anthelmintic drugs and micronutrients and the cost of this 'health package' per schooler per school year by the pharmaceutical companies was 100%. Efficiency of logistics to the schools, defined as the efficiency and cost of logistical delivery of the 'Health Package' from the State Head Quarters to the District to the Taluka to the School was 100%. Coverage defined as consumption of the 'Health Package' by schooler at least once in the 6-9 months of the school year, as stated by the implementing agency was 94%-100% (urban) and 42%-94% (rural); coverage as stated by the schoolchildren was 71%-79% (urban) and 50%-67% (rural). IMPACT EVALUATION: On average, students who received supplements were 1.1 kg heavier and 1.1 cm taller than those who did not; hemoglobin (Hb) levels were >12 g/dL intestinal parasite prevalence rates dropped from 71% to 39%; prevalence of night blindness and vitamin A deficiency were reduced from 67% to 34%. LESSON LEARNED: Since 2003, 4 states in India, namely, Gujarat, Andhra Pradesh, Karnataka, and Tamil Nadu covering approximately 30 million schoolers have adopted the "Gujarat Model."

Oral glutamine supplementation decreases resting energy expenditure in children and adolescents with sickle cell anemia.

OBJECTIVES: To determine the effects of orally administered glutamine on the resting energy expenditure (REE) and nutritional status of children and adolescents with sickle cell anemia. METHODS: Twenty-seven children and adolescents (13 boys, 14 girls), 5.2 to 17.9 years old (median 11.0 years), received orally administered glutamine (600 mg/kg per day) for 24 weeks. Measures of REE and other nutritional parameters were compared at baseline and 24 weeks. RESULTS: After 24 weeks, the patients' median REE (kcal/d) decreased by 6% (P = 0.053) as indicated by the Harris Benedict equations and by 5% (P = 0.049) as indicated by the modified equations. Patients with less than 90% ideal body weight had even greater declines in REE after 24 weeks (P < 0.03 and 0.02, respectively). Improvements in nutrition parameters and in two amino acids in the plasma were observed. CONCLUSIONS: After 24 weeks of orally administered glutamine, children and adolescents with sickle cell anemia had a decrease in REE and improvement in nutritional parameters. Those who were underweight had a greater decrease in REE than those of normal body weight. Lowering REE may be an effective way to improve the growth of these children and adolescents.

The effect of unselected post-operative nutritional supplementation on nutritional status and clinical outcome of orthopaedic patients.

BACKGROUND AND AIMS: Nutritional supplements are widely administered in hospitals and can benefit clinical outcome. The aim here was to determine the effect of routine post-operative nutritional supplementation on the nutritional status and clinical outcome of adult orthopaedic patients. METHODS: A prospective controlled study was conducted on two adult orthopaedic wards. Patients in the study group were prescribed two nutritional supplements/day post-operatively. Nutritional and biochemical indices and incidence of clinical complications were observed. RESULTS: Of 181 patients studied, 14 in the supplemented group and 34 in the control (P=0.005) developed major complications. There were 22 occurrences of major complications in the supplemented group and 55 in the control (P=0.0002). There was no significant difference in the number of minor complications between the two groups (P=0.2). There was no statistical difference in changes in nutritional parameters or in albumin or CRP between the two groups. There were significantly greater reductions in transferrin (P=0.002) and in haemoglobin (P=0.002) in the control group at week 1. The median costs of hospital stay were 2068 UK pounds in the supplemented group and 2199 UK pounds in the control. The median cost of additional treatments was 30.16 UK pounds in the supplemented group and 46.23 UK pounds in the control. CONCLUSION: A significant reduction in major complications and in number and costs of additional treatments was seen in the supplemented group.

Re-validation and shortening of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire.

PURPOSE: The original Functional Assessment of Anorexia/Cachexia Therapy (FAACT) was designed to measure general aspects of quality of life (QOL) as well as specific anorexia/cachexia-related concerns. Our primary purpose was to reduce the number of anorexia/cachexia subscale items in a manner that either retains or improves reliability, validity and precision. METHODS: The FAACT was administered using an interactive computer program that allowed immediate entry of the data. A total of 213 patients were recruited. RESULTS: A combined empirical and conceptual approach led to the reduction of the anorexia/cachexia subscale (A/CS) from 18 to 12 items. A 26-item trial outcome index (TOI) combining physical well-being (PWB), functional well-being (FWB), and the A/CS-12 was highly reliable and sensitive to change in performance status rating (PSR). We found that PWB, FWB, and A/CS-12 subscales performed differently. Specifically, PWB and FWB scores decreased in patients whose (PSR) worsened. However, although A/CS-12 scores were responsive to change in PSR over time, average A/CS-12 scores of all patients, even those whose PSR worsened, improved over the course of treatment. CONCLUSIONS: Elimination of six items from the anorexia/cachexia subscale of the FAACT was accomplished without loss of internal consistency or sensitivity to change in performance status. The A/CS-12 subscale provides unique, important information not captured by a generic chronic illness questionnaire.

Assessment of the effectiveness of drug therapies on nutritional status in the elderly: "concerning a randomised, double-blind clinical study of the activity of pancreatic extracts and a placebo during the renutrition of elderly subjects suffering from protein caloric undernutrition".

AIMS: to study, versus placebo, the value of administering pancreatic extracts in elderly subjects suffering from denutrition. METHODS: 52 subjects over 70 years of age, living in the Toulouse region of France, were included in this study. Each subject was required to present with an impaired nutritional status of their food intake, anthropometric and laboratory markers. RESULTS: among the 52 patients included in the study, 26 received the placebo and 26 received a pancreatic extract (Créon 12,000). 88% of these patients were women and 12% were men, the mean age of patients was 87+/-6 years. The groups were comparable at entry into the study. Nutritional intake increased in the two groups. There was a non-significant increase in body weight in the treated group when compared with the placebo group. DISCUSSION: we think that in the future, it would be preferable to conduct studies in convalescent subjects, reducing the frequency of nutritional assessments (food intake on D0 and D90, to reduce interference with the patient's habits.

Assessment of the nutritional effects of olestra, a nonabsorbed fat replacement: summary.

Olestra is a zero-calorie fat replacement intended to replace 100% of the fat used in the preparation of savory snacks. Olestra can affect the absorption of other dietary components, especially highly lipophilic ones, when ingested at the same time. The potential effects of olestra on the absorption of essential fat-soluble and water-soluble dietary components have been investigated in pigs and in humans. In these studies, subjects were fed daily amounts of olestra up to 10 times the estimated mean intake from savory snacks and the olestra was eaten each day of the studies. In real life, snacks are eaten on average five times in a 14-d period. Olestra did not affect the availability of water-soluble micronutrients or the absorption and utilization of macronutrients. Olestra reduced the absorption of fat-soluble vitamins A, D, E and K; however, the effects can be offset by adding specified amounts of the vitamins to olestra foods. Olestra also reduced the absorption of carotenoids; analysis of dietary patterns showed that in real life the reduction will likely be <10%. Any effect on vitamin A stores caused by a reduction in carotenoid uptake is offset by the addition of vitamin A to olestra foods. Because of the olestra-to-nutrient ratios fed and the nutritional requirements of the test subjects, the effects of olestra on nutritional status of subgroups of the population are unlikely to be different than those measured in the studies. An analysis of lipophilicity showed that olestra is unlikely to significantly affect the uptake of potentially beneficial phytochemicals from fruits and vegetables. Some people eating large amounts of olestra snacks may experience common GI symptoms such as stomach discomfort or changes in stool consistency, similar to symptoms accompanying other dietary changes. These symptoms present no health risks.