ESPEN guideline on hospital nutrition.

In hospitals through Europe and worldwide, the practices regarding hospital diets are very heterogeneous. Hospital diets are rarely prescribed by physicians, and sometimes the choices of diets are based on arbitrary reasons. Often prescriptions are made independently from the evaluation of nutritional status, and without taking into account the nutritional status. Therapeutic diets (low salt, gluten-free, texture and consistency modified, …) are associated with decreased energy delivery (i.e. underfeeding) and increased risk of malnutrition. The European Society for Clinical Nutrition and Metabolism (ESPEN) proposes here evidence-based recommendations regarding the organization of food catering, the prescriptions and indications of diets, as well as monitoring of food intake at hospital, rehabilitation center, and nursing home, all of these by taking into account the patient perspectives. We propose a systematic approach to adapt the hospital food to the nutritional status and potential food allergy or intolerances. Particular conditions such as patients with dysphagia, older patients, gastrointestinal diseases, abdominal surgery, diabetes, and obesity, are discussed to guide the practitioner toward the best evidence based therapy. The terminology of the different useful diets is defined. The general objectives are to increase the awareness of physicians, dietitians, nurses, kitchen managers, and stakeholders towards the pivotal role of hospital food in hospital care, to contribute to patient safety within nutritional care, to improve coverage of nutritional needs by hospital food, and reduce the risk of malnutrition and its related complications.

Antitumor Effect of 5-Fluorouracil-Loaded Liposomes Containing n-3 Polyunsaturated Fatty Acids in Two Different Colorectal Cancer Cell Lines.

It has been shown that long-chain n-3 polyunsaturated fatty acids (n-3 PUFAs) could act synergistically with 5-fluorouracil (5-FU) to kill cancer cells. To facilitate their simultaneous transport in the bloodstream, we synthesized, for the first time, liposomes (LIPUFU) containing 5-FU in the aqueous core and docosahexaenoic acid (DHA)/eicosapentaenoic acid (EPA) at a ratio of 1:2 in the lipid bilayer. LIPUFU werestable with uniform size of 154 ± 4 nm, PDI of 0.19 ± 0.03 and zeta potential of -41 ± 2 mV. They contained 557 ± 210 µmol/l DHA, 1467 ± 362 µmol/l EPA, and 9.8 ± 1.1 µmol/l 5-FU. Control liposomes without (LIP) or with only 5-FU (LIFU) or n-3 PUFAs (LIPU) were produced in a similar way. The effects of these different liposomal formulations on the cell cycle, growth, and apoptosis were evaluated in two human colorectal cancer (CRC) cell lines differing in sensitivity to 5-FU, using fluorescence-activated cell sorting analyses. LIPUFU were more cytotoxic than LIP, LIFU, and LIPU in both LS174T (p53+/+, bax-/-) and HT-29 (p53-/0, bax+/+) cell lines. Similar to LIFU, LIPUFU increased the percentage of cells in S phase, apoptosis, and/or necrosis. The cytotoxic potential of LIPUFU was confirmed in vivo by tumor growth inhibition in the chicken chorioallantoic membrane model. These results suggest that LIPUFU could be considered to facilitate the simultaneous transport of 5-FU and n-3 PUFAs to the tumor site, in particular in case of CRC liver metastases.

Ursolic acid has no additional effect on muscle strength and mass in active men undergoing a high-protein diet and resistance training: A double-blind and placebo-controlled trial.

BACKGROUND: Ursolic acid (UA) is thought to have an anabolic effect on muscle mass in humans. This study sought to compare the effects of UA and a placebo on muscle strength and mass in young men undergoing resistance training (RT) and consuming a high-protein diet. METHODS: A clinical, double-blind, placebo-controlled trial was conducted for 8 weeks. The Control + RT group (CON n = 12) received 400 mg/d of placebo, and the UA + RT group (UA n = 10) received 400 mg/d of UA. Both groups ingested ~1.6 g/kg of protein and performed the same RT program. Pre- and post-intervention, both groups were evaluated for anthropometric measures, body composition, food intake and muscle strength. RESULTS: Food intake remained unchanged throughout the study. Both groups showed significant increases in body weight (CON Δ: 2.12 ± 0.47 kg, p = 0.001 vs. UA Δ: 2.24 ± 0.67 kg, p = 0.009), body mass index (BMI) (CON Δ: 0.69 ± 0.15 kg/m2, p = 0.001 vs. UA Δ: 0.75 ± 0.23, p = 0.011) and thigh circumference (CON Δ: 1.50 ± 0.36, p = 0.002 vs. UA Δ: 2.46 ± 0.50 cm, p = 0.003 vs. UA 1.84 ± 0.82 cm, p = 0.001), with differences between them. There was no difference in the arm, waist and hip circumferences. Both groups showed increases in muscle mass (CON Δ: 1.12 ± 0.26, p = 0.001 vs. UA Δ: 1.08 ± 0.28 kg, p = 0.004), but there was no significant difference between them. Additionally, there were significant increases in the one repetition maximum test in the bench press and in the 10-repetition maximum test in the knee extension (CON Δ: 5.00 ± 2.09, p = 0.036 vs. UA Δ: 7.8 ± 1.87, p = 0.340 and CON Δ: 3.58 ± 1.15, p = 0.010 vs. UA Δ: 1.20 ± 0.72, p = 0.133), respectively, with no difference between them. CONCLUSIONS: Ursolic acid had no synergic effect on muscle strength and mass in response to RT in physically active men consuming a high-protein diet. BRAZILIAN CLINICAL TRIALS REGISTRY (REBEC): RBR-76tbqs.

Indirect calorimetry: The 6 main issues.

BACKGROUND AND AIMS: Optimal nutritional therapy, including the individually adapted provision of energy, is associated with better clinical outcomes. Indirect calorimetry is the best tool to measure and monitor energy expenditure and hence optimize the energy prescription. Similarly to other medical techniques, indications and contra-indications must be acknowledged to optimise the use of indirect calorimetry in clinical routine. Measurements should be repeated to enable adaptation to the clinical evolution, as energy expenditure may change substantially. This review aims at providing clinicians with the knowledge to routinely use indirect calorimetry and interpret the results. METHOD: We performed a bibliographic research of publications referenced in PubMed using the following terms: "indirect calorimetry", "energy expenditure", "resting energy expenditure", "VCO2", "VO2", "nutritional therapy". We included mainly studies published in the last ten years, related to indirect calorimetry principles, innovations, patient's benefits, clinical use in practice and medico-economic aspects. RESULTS: We have gathered the knowledge required for routine use of indirect calorimetry in clinical practice and interpretation of the results. A few clinical cases illustrate the decision-making process around its application for prescription, and individual optimisation of nutritional therapy. We also describe the latest technical innovations and the results of tailoring nutrition therapy according to the measured energy expenditure in medico-economic benefits. CONCLUSION: The routine use of indirect calorimetry should be encouraged as a strategy to optimize nutrition care.

Nutrition of the COVID-19 patient in the intensive care unit (ICU): a practical guidance.

Five to 10% of the coronavirus SARS-CoV-2-infected patients, i.e., with new coronavirus disease 2019 (COVID-19), are presenting with an acute respiratory distress syndrome (ARDS) requiring urgent respiratory and hemodynamic support in the intensive care unit (ICU). However, nutrition is an important element of care. The nutritional assessment and the early nutritional care management of COVID-19 patients must be integrated into the overall therapeutic strategy. The international recommendations on nutrition in the ICU should be followed. Some specific issues about the nutrition of the COVID-19 patients in the ICU should be emphasized. We propose a flow chart and ten key issues for optimizing the nutrition management of COVID-19 patients in the ICU.

Short-Term Creatine Supplementation May Alleviate the Malnutrition-Inflammation Score and Lean Body Mass Loss in Hemodialysis Patients: A Pilot Randomized Placebo-Controlled Trial.

BACKGROUND: Creatine supplementation has been proposed to alleviate muscle loss in various populations, but has not been investigated in hemodialysis (HD) patients. Thus, our objective was to evaluate whether creatine supplementation could attenuate the loss of lean body mass (LBM) and malnutrition-inflammation score (MIS) in HD patients. METHODS: A randomized, placebo-controlled, double blind, parallel-design study included HD patients, of both sexes, aged 18-59 years. The patients were allocated to a Placebo Group (PG; n = 15; received maltodextrin, 1st week: 40 g/day and 2nd-4th weeks: 10 g/day) and a Creatine Group (CG; n = 15; received creatine plus maltodextrin, 1st week: 20 g/day of creatine plus 20 g/day of maltodextrin and 2nd-4th weeks: 5 g/day of creatine plus 5 g/day of maltodextrin). Pre and post the intervention, patients were evaluated for food intake, MIS, body composition and biochemical parameters. RESULTS: CG group attenuated the MIS (Pre: 5.57 ± 0.72 vs. Post: 3.85 ± 0.47 score, P = 0.003) compared with PG (Pre: 5.71 ± 0.97 vs. Post: 5.36 ± 0.95 score, P = 0.317) (supplement × time P = 0.017, effect size: 0.964). The change of LBM was greater in CG than in PG (CG: Δ0.95 vs PG: Δ0.13 kg). At post-intervention, 28.6% of PG patients presented LBM loss and 71.4% remain stable. In contrast, 14.4% of CG patients had LBM loss, 42.8% remain stable and 42.8% gained. Food intake and quality of life did not change. CG increased the BMI and gait speed in post-compared to pre-moment, but no difference among the groups. CONCLUSION: In HD patients, four weeks of creatine supplementation may alleviate the MIS as well as attenuate the LBM loss compared to placebo.

Whey Protein Supplementation Compared to Collagen Increases Blood Nesfatin Concentrations and Decreases Android Fat in Overweight Women: A Randomized Double-Blind Study.

Protein supplements are usually used to control body weight, however, the impact of protein quality on body fat attenuation is unknown. We investigated the effects of isocaloric isoproteic supplementation of either whey protein (WG) or hydrolysed collagen supplementation (CG) on dietary intake, adiposity and biochemical markers in overweight women. METHODS: In this randomized double-blind study, 37 women, [mean ± SE, age 40.6 ± 1.7 year; BMI (kg/m2) 30.9 ± 0.6], consumed sachets containing 40 g/day of concentrated whey protein (25 g total protein, 2.4 leucine, 1.0 valine, 1.5 isoleucine, n = 17) or 38 g/day of hydrolysed collagen (26 g total protein, 1.02 leucine, 0.91 valine, 0.53 isoleucine, n = 20) in the afternoon snack. The compliance was set at >70% of the total theoretical doses. The dietary intake was evaluated by a 6-day food record questionnaire. At the beginning and after eight weeks of follow-up, body composition was evaluated by using dual-energy X-ray absorptiometry and lipid profile, insulin resistance, C-reactive protein, adiponectin, leptin and nesfastin plasma concentrations were analyzed. RESULTS: Supplements were isocaloric and isoproteic. There were no differences in caloric intake (p = 0.103), protein (p = 0.085), carbohydrate (p = 0.797) and lipids (p = 0.109) intakes. The branched chain amino acids (BCAA) (GC: 1.8 ± 0.1 g vs. WG: 5.5 ± 0.3 g, p < 0.001) and leucine intake (CG: 0.1 ± 0.1 g vs. WG: 2.6 ± 0.1 g, p < 0.001) were higher in WG compared to CG. BMI increased in the CG (0.2 ± 1.1 kg/m2, p = 0.044) but did not change in WG. WG decreased the android fat (-0.1 ± 0.3 kg, p = 0.031) and increased nesfatin concentrations (4.9 ± 3.2 ng/mL, p = 0.014) compared to CG. CONCLUSIONS: Whey protein supplementation in overweight women increased nesfatin concentrations and could promote increase of resting metabolic rate as part of body composition improvement programs compared to collagen supplementation for 8 weeks. Additionally, our findings suggest that collagen may not be an effective supplement for overweight women who are attempting to alter body composition.

ESPEN guideline on clinical nutrition in the intensive care unit.

Following the new ESPEN Standard Operating Procedures, the previous guidelines to provide best medical nutritional therapy to critically ill patients have been updated. These guidelines define who are the patients at risk, how to assess nutritional status of an ICU patient, how to define the amount of energy to provide, the route to choose and how to adapt according to various clinical conditions. When to start and how to progress in the administration of adequate provision of nutrients is also described. The best determination of amount and nature of carbohydrates, fat and protein are suggested. Special attention is given to glutamine and omega-3 fatty acids. Particular conditions frequently observed in intensive care such as patients with dysphagia, frail patients, multiple trauma patients, abdominal surgery, sepsis, and obesity are discussed to guide the practitioner toward the best evidence based therapy. Monitoring of this nutritional therapy is discussed in a separate document.

Prescription and indication for oral nutritional supplements in a Swiss university hospital: a prospective survey.

AIMS OF THE STUDY: Patients with an acute or chronically negative nutritional balance are at nutritional risk. Oral nutritional supplements (ONS) are simple and effective medical treatments of nutritional risk. In the ambulatory setting, in Switzerland, ONS are reimbursed by public insurance under conditions defined by Swiss Society for Clinical Nutrition. The reimbursement requires a medical prescription for ONS and their delivery at the patient's home by a homecare service. The indication for the ONS, defined as a Nutritional Risk Screening-2002 (NRS-2002) score ≥3, must also be present. This survey aimed to document: (i) the existence of a medical prescription for ONS during hospitalisation and discharge for home, (ii) the adequacy of the indication for ONS during hospitalisation and at discharge for home, and (iii) the continuation or not of ONS treatment 1 month after discharge for home. METHODS: This prospective survey included adult patients hospitalised in the departments of surgery, medicine or rehabilitation and who were about to receive ONS for the first time. Patients already on ONS, with major consciousness disorders, who refused to take ONS or to participate to the survey were excluded. The existence of a medical prescription for ONS and the adequacy of the indication (Nutritional Risk Screening-2002 [NRS-2002] score ≥3) were evaluated at first ONS delivery and at hospital discharge. At home, the continuation of ONS consumption was evaluated by the homecare service 1 month after discharge. Results are presented as mean ± standard deviation or frequencies and percentages, and comparisons between patients with and without ONS at discharge for home. RESULTS: A total of 416 patients (age 71.7 ± 14.1 yr, 52.6% male, body mass index 23.6 ± 5.2 kg/m2) were included. At the first delivery of ONS, 44.5% (n = 185) of patients had no medical prescription for the supplements, and 82.7% (n = 344) had an NRS-2002 score ≥3. Out of 207 patients discharged for home, only 24.2% (n = 50) had an adequate homecare ONS prescription and 68% (n = 141) had a NRS-2002 score ≥3. One month after discharge for home, 76% (n = 29) were still taking ONS. CONCLUSIONS: In our survey, only few patients receiving ONS during the hospital stay had a medical prescription for ONS during the hospitalisation and at discharge for home. For most patients receiving ONS during hospitalisation and at discharge for home, an NRS-2002 score of ≥3 was present. If a medical prescription was provided, ONS were generally continued one month after discharge for home. CLINICAL TRIAL REGISTRATION NUMBER: NCT02476110.

Indirect calorimetry in nutritional therapy. A position paper by the ICALIC study group.

BACKGROUND & AIMS: This review aims to clarify the use of indirect calorimetry (IC) in nutritional therapy for critically ill and other patient populations. It features a comprehensive overview of the technical concepts, the practical application and current developments of IC. METHODS: Pubmed-referenced publications were analyzed to generate an overview about the basic knowledge of IC, to describe advantages and disadvantages of the current technology, to clarify technical issues and provide pragmatic solutions for clinical practice and metabolic research. The International Multicentric Study Group for Indirect Calorimetry (ICALIC) has generated this position paper. RESULTS: IC can be performed in in- and out-patients, including those in the intensive care unit, to measure energy expenditure (EE). Optimal nutritional therapy, defined as energy prescription based on measured EE by IC has been associated with better clinical outcome. Equations based on simple anthropometric measurements to predict EE are inaccurate when applied to individual patients. An ongoing international academic initiative to develop a new indirect calorimeter aims at providing innovative and affordable technical solutions for many of the current limitations of IC. CONCLUSION: Indirect calorimetry is a tool of paramount importance, necessary to optimize the nutrition therapy of patients with various pathologies and conditions. Recent technical developments allow broader use of IC for in- and out-patients.

Twelve key nutritional issues in bariatric surgery.

In morbidly obese patients, i.e. body mass index ≥35, bariatric surgery is considered the only effective durable weight-loss therapy. Laparoscopic Roux-en-Y gastric bypass (LRYGBP), laparoscopic sleeve gastrectomy (LSG), and biliopancreatic diversion with duodenal switch (BPD-DS) are associated with risks of nutritional deficiencies and malnutrition. Therefore, preoperative nutritional assessment and correction of vitamin and micronutrient deficiencies, as well as long-term postoperative nutritional follow-up, are advised. Dietetic counseling is mandatory during the first year, optional later. Planned and structured physical exercise should be systematically promoted to maintain muscle mass and bone health. In this review, twelve key perioperative nutritional issues are raised with focus on LRYGBP and LSG procedures, the most common current bariatric procedures.

[Oral nutritive supplements : efficiency and clinical use in community-dwelling patients]. / Suppléments nutritifs oraux : efficacité et aspects pratiques en ambulatoire.

Undernutrition represents a wide-spread clinical state in outpatients and inpatients. It is associated with a high morbidity and mortality, an impaired quality of life, and increased healthcare costs. Early diagnosis and treatement help to reduce these medical and economic consequences. Oral nutritive supplements (ONS) are simple, effective and economic medical treatments to fight against undernutrition. However, they are insufficiently used for outpatients because of lack of knowledge. This article reviews the impact of ONS, their indications and contraindications and their modalities of prescription and focuses especially on community-dwelling patients.

La dénutrition est un état clinique répandu chez les personnes hospitalisées et ambulatoires. Elle augmente la morbi-mortalité, les coûts et diminue la qualité de vie. Un diagnostic et une prise en charge précoces permettent de diminuer ses conséquences médico-économiques. Les suppléments nutritifs oraux (SNO) sont un traitement médical simple, efficace et économique pour lutter contre la dénutrition. Ils sont peu utilisés chez les patients ambulatoires, car méconnus. Cet article précise l'impact des SNO, les indications et les contre-indications, et les modalités de prescription, en se focalisant sur les patients ambulatoires.

Interaction of ω-3 polyunsaturated fatty acids with radiation therapy in two different colorectal cancer cell lines.

BACKGROUND & AIMS: This study aims at evaluating if docosahexaenoic acid (DHA) or eicosapentaenoic acid (EPA) increases the efficacy of radiation therapy (RT) on two human colorectal cancer cell lines with different radio-sensitivity. METHODS: LS174T and HT-29 cells were treated with 20 or 50 µmol/L EPA or DHA followed by single X-ray RT of 0, 2 or 4 Gy, to evaluate cell survival, apoptosis, peroxide and malondialdehyde productions. Inflammation- and apoptosis-related proteins were analyzed by Western Blot. ANOVAs were used for statistical analysis. RESULTS: LS174T was more sensitive to RT than HT-29. DHA and to a lesser extent EPA increased cell death, apoptosis and peroxide production after RT in LS174T and to a lesser extent in HT-29 (p < 0.05). This was associated with increased expression of heat shock protein 70, decreased expression of NF-kB p65, COX-2 and Bcl-2 proteins. CONCLUSIONS: The effect of RT combination with DHA and to a lesser extent EPA was synergistic in the radio-sensitive LS174T cells, but additive in the radio-resistant HT-29 cells. This enhanced cytotoxicity was provoked at least partly by lipid peroxidation, which consequently modulated inflammatory response and induced apoptosis.

Green tea polyphenol epigallocatechin-3-gallate (EGCG) as adjuvant in cancer therapy.

BACKGROUND & AIMS: Green tea catechins, especially epigallocatechin-3-gallate (EGCG), have been associated with cancer prevention and treatment. This has resulted in an increased number of studies evaluating the effects derived from the use of this compound in combination with chemo/radiotherapy. This review aims at compiling latest literature on this subject. METHODS: Keywords including EGCG, cancer, chemotherapy, radiotherapy and side effects, were searched using PubMed and ScienceDirect databases to identify, analyze, and summarize the research literature on this topic. Most of the studies on this subject up to date are preclinical. Relevance of the findings, impact factor, and date of publication were critical parameters for the studies to be included in the review. RESULTS: Additive and synergistic effects of EGCG when combined with conventional cancer therapies have been proposed, and its anti-inflammatory and antioxidant activities have been related to amelioration of cancer therapy side effects. However, antagonistic interactions with certain anticancer drugs might limit its clinical use. CONCLUSIONS: The use of EGCG could enhance the effect of conventional cancer therapies through additive or synergistic effects as well as through amelioration of deleterious side effects. Further research, especially at the clinical level, is needed to ascertain the potential role of EGCG as adjuvant in cancer therapy.

Effects of widely used drugs on micronutrients: a story rarely told.

Vitamins and trace elements are essential to the body, however, deficiencies are frequently observed in the general population. Diet is mostly responsible for these deficiencies but drugs also may play a significant role by influencing their metabolism. These effects are rarely assessed in clinical practice, in part because of limited data available in the literature. Drug-induced micronutrient depletions, however, may be the origin of otherwise unexplained symptoms that might sometimes influence medication compliance. We present various examples of widely prescribed drugs that can precipitate micronutrient deficiencies. This review aims at sensitizing physicians on drug-micronutrient interactions. High-risk population groups also are presented and supplementation protocols are suggested.

Colon cancer cell chemosensitisation by fish oil emulsion involves apoptotic mitochondria pathway.

Adjuvant use of safe compounds with anti-tumour properties has been proposed to improve cancer chemotherapy outcome. We aimed to investigate the effects of fish oil emulsion (FOE) rich in n-3 PUFA with the standard chemotherapeutic agents 5-fluorouracil (5-FU), oxaliplatin (OX) or irinotecan (IRI) on two human colorectal adenocarcinoma cells with different genetic backgrounds. The HT-29 (Bax+/+) and LS174T (Bax-/-) cells were co-treated for 24-72 h with 1 µm-5-FU, 1 µm-OX or 10 µm-IRI and/or FOE dilution corresponding to 24 µm-EPA and 20·5 µm-DHA. Soyabean oil emulsion (SOE) was used as isoenergetic and isolipid control. Cell viability, apoptosis and nuclear morphological changes were evaluated by cytotoxic colorimetric assay, flow cytometry analysis with annexin V and 4',6'-diamidino-2-phenylindole staining, respectively. A cationic fluorescent probe was used to evaluate mitochondrial dysfunction, and protein expression involved in mitochondrial apoptosis was determined by Western blot. In contrast to SOE, co-treatment with FOE enhanced significantly the pro-apoptotic and cytotoxic effects of 5-FU, OX or IRI in HT-29 but not in LS174T cells (two-way ANOVA, P <0.01). These results were confirmed by the formation of apoptotic bodies in HT-29 cells. A significant increase in mitochondrial membrane depolarisation was observed after the combination of 5-FU or IRI with FOE in HT-29 but not in LS174T cells (P <0.05). Co-administration of FOE with the standard agents, 5-FU, OX and IRI, could be a good alternative to increase the efficacy of chemotherapeutic protocols through a Bax-dependent mitochondrial pathway.

Parenteral nutrition.

Parenteral nutrition (PN) is a technique of nutritional support, which consists of intravenous administration of macronutrients (glucose, amino acids, and triglycerides), micronutrients (vitamins and trace elements), water, and electrolytes. Early studies indicate that the use of total PN was associated with increased mortality and infectious morbidity. These detrimental effects of PN were related to hyperglycemia and overfeeding at a period when PN was administered according to the principle that the higher calories the patients received, the better their outcome would be. Enteral nutrition (EN) then replaced PN as the gold standard of nutritional care in the intensive care unit (ICU). However, EN alone is frequently associated with insufficient energy coverage, and subsequent protein-energy deficit is correlated with a worse clinical outcome. Infectious and metabolic complications of PN could be prevented if PN is used by a trained team using a validated protocol, only when indicated, not within the first 2 days following ICU admission, and limited through the time. In addition, energy delivery has to be matched to the energy target, and adapted glucose control should be obtained. In patients with significant energy deficit (>40%), the combination of PN and EN, i.e. supplemental PN, from day 4 of the ICU stay, could improve the clinical outcome of ICU patients as compared with EN alone. Therefore, PN should be integrated in the management of ICU patients with the aim of prevent the worsening of energy deficits, allowing the preservation of lean body mass loss, and reducing the risk of undernutrition-related complications.

Vitamin E content in fish oil emulsion does not prevent lipoperoxidative effects on human colorectal tumors.

OBJECTIVE: The anticancer action exerted by polyunsaturated fatty acid peroxidation may not be reproduced by commercially available lipid emulsions rich in vitamin E. Therefore, we evaluated the effects of fish oil (FO) emulsion containing α-tocopherol 0.19 g/L on human colorectal adenocarcinoma cells and tumors. METHODS: HT-29 cell growth, survival, apoptosis, and lipid peroxidation were analyzed after a 24-h incubation with FO 18 to 80 mg/L. Soybean oil (SO) emulsion was used as an isocaloric and isolipidic control. In vivo, nude mice bearing HT-29 tumors were sacrificed 7 d after an 11-d treatment with intravenous injections of FO or SO 0.2 g ∙ kg(-1) ∙ d(-1) FO or SO to evaluate tumor growth, necrosis, and lipid peroxidation. RESULTS: The FO inhibited cell viability and clonogenicity in a dose-dependent manner, whereas SO showed no significant effect compared with untreated controls. Lipid peroxidation and cell apoptosis after treatment with FO 45 mg/L were increased 2.0-fold (P < 0.01) and 1.6-fold (P = 0.04), respectively. In vivo, FO treatment did not significantly affect tumor growth. However, immunohistochemical analyses of tumor tissue sections showed a decrease of 0.6-fold (P < 0.01) in the cell proliferation marker Ki-67 and an increase of 2.3-fold (P = 0.03) in the necrotic area, whereas malondialdehyde and total peroxides were increased by 1.9-fold (P = 0.09) and 7.0-fold (P < 0.01), respectively, in tumors of FO-treated compared with untreated mice. CONCLUSION: These results suggest that FO but not SO has an antitumor effect that can be correlated with lipid peroxidation, despite its vitamin E content.

Outcome models in clinical studies: implications for designing and evaluating trials in clinical nutrition.

BACKGROUND & AIMS: The selection of appropriate outcome variables in clinical nutrition is particularly challenging, since nutrition is an adjunct therapy in most cases. Therefore, its effect may be confounded with the primary therapy, and classic biomedical outcomes may not reflect the effect of the nutritional intervention. This paper scrutinizes different alternatives to the biomedical perspective. RESULTS: Five different outcome models are proposed and analyzed for their suitability in clinical nutrition studies: biomedical, patient-centered/-reported, health economic, decision-making, and integration of classical and patient-reported endpoints. Most published studies in the field of clinical nutrition make use of biomedical endpoints, but the growing importance of patient-centered/-reported and health economic outcomes is recognized. We recommend avoiding to focus solely on biomedical endpoints in clinical nutrition studies. The availability and value of a broader set of outcome-models should be acknowledged. CONCLUSION: Patient-centered/-reported, health economic or combined endpoints are particularly useful to assess the effect of nutritional therapies, especially when applied in conjunction with a primary therapy. The proposed outcome models can also contribute to refine clinical nutrition guidelines in assessing the clinical relevance of the study results.