Search Results (16)

Accurate assessment of protein content in Foods for Special Medical Purposes (FSMPs) is critical for patients with chronic kidney disease, who require tightly regulated protein intake. This study aimed to develop and apply a rapid, low-volume, and reproducible microchip-based gel electrophoresis method for analyzing total nitrogen (TN) content and electrophoretic profiles in FSMPs. Products of different consistencies (powder, liquid, yoghurt-like) were tested to evaluate the influence of common additives (e.g., milk proteins, stabilizers, sweeteners) on TN levels and protein patterns. The results revealed considerable variation in fractions among brands, largely attributable to additive composition. Notably, TN levels often exceeded the declared protein content, potentially leading to unintended nitrogen overconsumption in clinical settings. Statistical analysis identified significant TN differences between infant and adult FSMPs in liquid formulations, while powdered forms showed no such distinction. These findings highlight the clinical importance of precise analytical monitoring, as discrepancies between measured TN and labeled protein content could compromise dietary management in vulnerable populations. The proposed method provides a reliable tool for FSMP quality control and supports safer nutritional planning in therapeutic diets. Full article

A dysphagia diet is a special dietary programme. The development and design of foods for dysphagia should consider both swallowing safety and food nutritional quality. In this study, we investigated the rheological properties (viscosity, thixotropy, and viscoelasticity), textural properties, and swallowing behaviour of commercially available natural, pregelatinised, acetylated, and phosphorylated maize starch and tapioca starch. The results showed that all the samples belonged to food grade 3 in the framework of the International Dysphagia Dietary Standardization Initiative (IDDSI) and exhibited shear-thinning behaviour in favour of dysphagia patients, except for the sample containing pregelatinised starch, which was grade 2. Rheological tests showed that the samples had good structural recovery properties. At the same starch concentration, the elastic modulus of phosphorylated cassava starch FSMP was significantly greater than that of the starch solution, whereas that of acetylated starch was significantly less than that of the starch solution, and the combination of acetylated starch and protein led to a significant viscosity reduction phenomenon, resulting in FSMPs with good stability and fluidity; this may provide an opportunity for the incorporation of more high-energy substructures. The textural results showed that all the samples possessed textural properties of low hardness, low adhesion, and high cohesion, all of which could be used as food for dysphagia patients. This study may provide a theoretical basis for the creation and design of novel nutritional foods for dysphagia. Full article

Background/Objectives: Melanoma malignum is considered the most dangerous form of skin cancer, characterized by the exceptional resistance to many conventional chemotherapies. The aim of this study was to evaluate the effect of Nutramil^TM Complex (NC)—Food for Special Medical Purpose (FSMP), on two types of melanoma cell lines, primary WM115 and malignant WM266-4. Methods: At 24 h after seeding, growth medium was replaced with a medium containing encoded treatments of NC or NC-CC (Nutramil^TM Complex without calcium caseinate) at various concentrations. Cells were treated for 24, 48, and 72 h. Results: Our results showed that Nutramil^TM Complex reduces proliferation of malignant melanoma WM266-4 cells but did not affect the proliferation of WM115 primary melanoma. This was followed by measured down-regulation of selected pro-survival proteins expression in WM266-4 cells, specifically ERK1/2, AKT-1, HSP27, Survivin, and TAK1. Interestingly, our results showed elevated levels of some pro-apoptotic proteins in both cell lines, including Bad, Smad2, p38MAPK, cleaved forms of Caspase-3/7, as well as cleaved PARP. Conclusions: Taken together, our results indicate that various melanoma cancer cell lines may respond in a different way to the same compound. They also suggest induction of apoptotic pathway by Nutramil^TM Complex as the most likely mechanism of its anticarcinogenic activity. Full article

Background: Disease-related malnutrition, with or without inflammation, in older adults is currently emerging as a public health priority. The use of Foods for Special Medical Purposes, including Oral Nutritional Supplements, and supplements is crucial to support patients in achieving their nutritional needs. Therefore, this article aims to comprehensively provide an analysis of the adequacy of FSMPs in meeting the nutritional requirements of different age-related diseases and takes into account the emerging role of inflammation. Moreover, it provides an identikit of the ideal products, following the pathology-specific guidelines. Methods: Data on 132 products were gathered through face-to-face meetings with companies’ consultants. Specifically, information on energy, macronutrient, and micronutrient contents were collected, as well as on texture and flavors, osmolarity, cost, and packaging. Results: Most FSMPs met the daily recommendations for energy and protein intake. Nonetheless, few products contained β-hydroxy-β-methylbutyrate, optimal Branched-Chain Amino Acids ratios, arginine, glutamine, and omega-3 fatty acids. Furthermore, a marked predominance of FSMPs with a high osmolarity (85.7%), sweet taste (72%), and only animal protein content (79.5%) was observed. Cost analysis of FSMPs revealed a mean cost of EUR 5.35/portion. Products were mostly adequate for cancer, neurodegenerative diseases, diabetes, inflammatory bowel disease, end-stage kidney disease, dysphagiam and chronic obstructive pulmonary disease. However, gaps have been found for sarcopenia and abdominal surgery. Conclusion: In light of the current market landscape, there is a need for a comprehensive regulation that indicates the optimal composition of FSMPs and the production of such products to tackle disease-related malnutrition. Full article

Enteral nutrition (EN) and foods for special medical purposes (FSMPs) can be used to meet the specific nutritional needs of patients. There are multiple types of EN products and nutritionally complete FSMPs on the market. The peptides in these products are important nutritional components, while their presence in different products remains unclear. To provide better clinical guidelines, we analyzed and compared the molecular weight (MW) distribution, types, and quantities of peptides and bioactive peptides of two EN products (liquid products) and two FSMPs with nutritionally complete formulas (powder products). Our results showed that each product had a unique peptide profile. The two liquid products and one powder product (Samples 1–3) had a higher content of peptides. Sample 1 contained 75.60% peptides with an MW less than 375 Da and contained 95.21% peptides with an MW less than 1000 Da, being rich in short peptides. Sample 2 and 3 had high levels of peptides with MW values between 180 Da and 2000 Da. Additionally, Sample 4 contained high levels of proteins, containing 69.18% peptides with MW values larger than 10,000 Da. Further, Sample 1 had more bioactive dipeptides and Sample 2 had more long bioactive peptides. Our results suggest that peptides in different EN and FSMP products are very different and should be evaluated in more detail. This will provide valuable information for clinical medical professionals, help them to guide patients with different physiological conditions better, and ultimately benefit patients. Full article

Background: Patients during radiotherapy due to head and neck cancers experience a lot of side effects which may have a considerable impact on the patients’ ability to meet individual daily energy demands by means of oral diet. Methods: The study included 104 head and neck cancer patients who qualified for radical radiotherapy. Radical treatment takes 6 weeks and every week the patients were assessed for dietary intake. The subjects were covered with the constant care of a dietician, received FSMP (food for special medical purposes), and, if necessary, enteral nutrition. Results: In the first week of treatment, the patients, from the kitchen diet alone, met 91.5% of the energy demand, while in the last week of treatment, only 40.9%. After introducing the FSMP or enteral nutrition, the patients met 120% of the demand in the first week of therapy and 95% in the last week, respectively. The patients who followed the dietary recommendations were characterized by significantly lower weight loss (3.07 kg) compared to non-adherent patients (5.56 kg). Conclusions: The used therapy significantly contributed to decreasing nutritional intake in the subsequent weeks of treatment. On the other hand, incorporating FSMP in the diet and enteral nutrition with industrial diets significantly increased the fulfilled energy demand of patients. Full article

Adequate diet, physical activity, and dietary supplementation with muscle-targeted food for special medical purposes (FSMP) or dietary supplement (DS) are currently considered fundamental pillars in sarcopenia treatment. The aim of this study is to evaluate the effectiveness of a DS (containing hydroxy-methyl-butyrate, carnosine, and magnesium, for its action on muscle function and protein synthesis and butyrate and lactoferrin for their contribution to the regulation of gut permeability and antioxidant/anti-inflammation activity) on muscle mass (assessed by dual X-ray absorptiometry (DXA)), muscle function (by handgrip test, chair test, short physical performance battery (SPPB) test, and walking speed test), inflammation (tumor necrosis factor-alpha (TNF-a), C-reactive protein (CRP), and visceral adipose tissue (VAT)) and gut axis (by zonulin). A total of 59 participants (age 79.7 ± 4.8 years, body mass index 20.99 ± 2.12 kg/m²) were enrolled and randomly assigned to intervention (n = 30) or placebo (n = 28). The skeletal muscle index (SMI) significantly improved in the supplemented group compared to the placebo one, +1.02 (CI 95%: −0.77; 1.26), p = 0.001; a significant reduction in VAT was observed in the intervention group, −70.91 g (−13.13; −4.70), p = 0.036. Regarding muscle function, all the tests significantly improved (p = 0.001) in the supplemented group compared to the placebo one. CRP, zonulin, and TNF-alpha significantly decreased (p = 0.001) in intervention, compared to placebo, −0.74 mg/dL (CI 95%: −1.30; −0.18), −0.30 ng/mL (CI 95%: −0.37; −0.23), −6.45 pg/mL (CI 95%: −8.71; −4.18), respectively. This DS improves muscle mass and function, and the gut muscle has emerged as a new intervention target for sarcopenia. Full article

This study aimed to investigate Romanian physicians’ awareness, recommendation practices, and opinions regarding the use of Foods for Special Medical Purposes (FSMPs) products. A total of ten physicians were interviewed using a structured questionnaire, and their responses were analysed using thematic content analysis. The study found that physicians were aware of FSMPs and recommended them to their patients based on nutritional deficits, weight loss, or deglutition impairments. In addition, disease stage, treatment scheme, taste, affordability, and availability were identified as factors influencing the recommendation and use of FSMPs. While physicians generally did not consult clinical trials, clinical experience was deemed essential for recommending FSMPs to patients. Patients’ feedback regarding the usage and sourcing of FSMPs was generally positive, with some expressing concerns about the availability of different flavours and the costs of purchasing the products. This study concluded that physicians play a vital role in recommending FSMPs to patients and ensuring they have the necessary nutritional support during treatment. However, it may be imperative to consider the provision of additional patient education materials and fostering collaborative efforts with nutritionists in order to optimise the prospects of positive outcomes in oncology treatment, while simultaneously alleviating the financial burdens faced by patients. Full article

The scoping review aimed to characterise the role of selected essential elements (Zn, Cu, Se, Fe, Mn) in food for special medical purposes (FSMPs) aimed at oncology patients. The scope review was conducted using Scopus, Google Scholar, and Web of Science to find published references on this subject. Data from the reviewed literature were related to the physiological functions of the element in the body, and the effects of deficiencies and excesses, referring to the latest ESPEN and EFSA guidelines, among others. Important dietary indices/parameters based on the literature review are provided for each element. On the basis of the literature, data on the level of elements in patients with cancer were collected. The content of these elements in 100 mL of FSMPs was read from the manufacturers’ declarations. The literature has been provided on the importance of each element in cancer. Our findings show that the essential elements (Zn, Cu, Se, Fe, and Mn) of FSMPs for cancer patients are not adequately treated. We suggest solutions to ensure the safe use of FSMPs in oncology patients. Full article

The hypoglycemic and lipid-lowering effects of glucomannan are widely known, and it is a potential effective treatment for type II diabetes. In this study, we evaluated the effects of glucomannan supplementation on blood-lipid-related indicators, blood-glucose-related indicators, blood pressure (BP), and body weight (BW) in patients suffering from type II diabetes. We searched databases including PubMed, Cochrane, the comprehensive biomedical research database (Embase), Web of Science, and China National Knowledge Infrastructure (CNKI) for literature on glucomannan and type II diabetes. Six randomized controlled trials (RCTs) were eligible (n = 440 participants) to be included in our analysis. Glucomannan not only reduced the total cholesterol (TC) (MD −0.38 [95% CI: −0.61, −0.15], p = 0.001) and low-density lipoprotein (LDL) levels (MD −0.35 [95% CI: −0.52, −0.17], p < 0.0001) compared with the control group, but also reduced the fasting blood glucose (FBG) (MD −1.08 [95% CI: −1.65, −0.50], p = 0.0002), 2 h postprandial blood glucose (P2hBG) (MD −1.92 [95% CI: −3.19, −0.65], p = 0.003), fasting insulin (FINS) (MD −1.59 [95% CI: −2.69, −0.50], p = 0.004), and serum fructosamine (SFRA) levels (SMD −1.19 [95% CI: −1.74, −0.64], p < 0.0001). Our analysis indicates that glucomannan is an effective nutritional intervention for type II diabetes. Full article

There are many factors causing T2DM; thus, it is difficult to prevent and cure it with conventional treatment. In order to realize the continuous intervention of T2DM, the treatment strategy of combining diet therapy and traditional medication came into being. As a natural product with the concept of being healthy, konjac flour and its derivatives are popular with the public. Its main component, Konjac glucomannan (KGM), can not only be applied as a food additive, which greatly improves the taste and flavor of food and extends the shelf life of food but also occupies an important role in T2DM. KGM can extend gastric emptying time, increase satiety, and promote liver glycogen synthesis, and also has the potential to improve intestinal flora and the metabolic system through a variety of molecular pathways in order to positively regulate oxidative stress and immune inflammation, and protect the liver and kidneys. In order to establish the theoretical justification for the adjunctive treatment of T2DM, we have outlined the physicochemical features of KGM in this article, emphasizing the advantages of KGM as a meal for special medical purposes of T2DM. Full article

Hospital Acquired Pneumonia (HAP) is one of the most common complications and late causes of death in TBI patients. Targeted prevention and treatment of HAP are of great significance for improving the prognosis of TBI patients. In the previous clinical observation, we found that folic acid treatment for TBI patients has a good effect on preventing and treating HAP. We conducted this retrospective cohort study to demonstrate what we observed by selecting 293 TBI patients from two medical centers and analyzing their hospitalization data. The result showed that the incidence of HAP was significantly lower in TBI patients who received folic acid treatment (44.1% vs. 63.0%, p = 0.012). Multivariate logistic regression analysis showed that folic acid treatment was an independent protective factor for the occurrence of HAP in TBI patients (OR = 0.418, p = 0.031), especially in high-risk groups of HAP, such as the old (OR: 1.356 vs. 2.889), ICU (OR: 1.775 vs. 5.996) and severe TBI (OR: 0.975 vs. 5.424) patients. At the same time, cohort studies of HAP patients showed that folic acid also had a good effect on delaying the progression of HAP, such as reducing the chance of tracheotomy (26.1% vs. 50.8%, p = 0.041), and reduced the length of hospital stay (15 d vs. 19 d, p = 0.029) and ICU stay (5 d vs. 8 d, p = 0.046). Therefore, we believe that folic acid treatment in TBI patients has the potential for preventing and treating HAP, and it is worthy of further clinical research. Full article

Background: The effect of serum L-carnitine (LC) concentrations on cancer risk remains unclear. This study aims to explore the association between serum LC and the risk of incident cancer. Methods: This is a case-control study, including 574 patients with incident cancer and 574 controls matched in a 1:1 ratio by age, sex, and residence, nested within the China H-Type Hypertension Registry Study (CHHRS). Conditional logistic regression analysis was used to assess the association of serum LC and incident cancer risk. Results: When LC was assessed as quartiles, compared with patients with low LC (Q1), patients in the highest quartile (Q4) had a 33% (OR = 0.67, 95% CI: 0.46 to 0.99), 52% (OR = 0.48, 95% CI: 0.23 to 0.99), and 39% (OR = 0.61, 95% CI: 0.38 to 0.99) decreased risk of overall, digestive system, and non-digestive system cancer in the adjusted models, respectively. In subgroup analyses, an inverse association of LC with cancer risk was observed in individuals who were overweight (obese), who never drink, who never smoke, and who were female. In the mediation analysis, serum trimethylamine-N-oxide (TMAO) concentrations did not mediate the reversed association of LC with cancer risk. Conclusions: This study showed that serum LC concentrations had a protective impact on overall, digestive system, and non-digestive system cancer risk. Full article

The consumption of dietary amino acids has been evaluated for therapeutic and safety intervention in obesity. In particular, three molecules have been shown to be effective: arginine, glutamine and leucine (and its metabolite beta-hydroxy-beta-methylbutyrate, HMB). This randomized, double-blinded pilot study in obese postmenopausal patients aimed to evaluate the efficacy of the administration of a specific food for special medical purposes (FSMP) consisting of arginine, glutamine and HMB on body composition, in particular, visceral adipose tissue (VAT), assessed by dual-energy X-ray absorptiometry (DXA), as the primary endpoint. The secondary endpoint was to evaluate the effects on skin health through a validated self-reported questionnaire. A significant improvement on VAT of Δ = −153.600, p = 0.01 was recorded in the intervention group. Skin health showed a significant improvement in the treatment group for the following: bright Δ = 1.400 (0.758; 2.042), elasticity Δ = 0.900 (0.239; 1.561), wrinkles Δ = 0.800 (0.276; 1.324), and on total score, Δ = 3.000 (1.871; 4.129). In the intervention group, the improvement in VAT was associated with an improvement in the bright score (r = −0.58; p = 0.01). In conclusion, this study demonstrated that the intake for 4-weeks of arginine, glutamine and HMB effects a significant reduction in VAT and improves skin condition, while fat free mass (FFM) is maintained, thus achieving “high-quality” weight loss. Full article

The nutritional composition of special low protein foods (SLPFs) is controlled under EU legislation for ‘Foods for Special Medical Purposes (FSMP)’. They are designed to meet the energy needs of patients unable to eat a normal protein containing diet. In phenylketonuria (PKU), the macronutrient contribution of SLPFs has been inadequately examined. Aim: A 3-year longitudinal prospective study investigating the contribution of SLPFs to the macronutrient intake of children with early treated PKU. Methods: 48 children (27 boys) with a mean recruitment age of 9.3 y were studied. Semi-quantitative dietary assessments and food frequency questionnaires (FFQ) were collected three to four times/year for 3 years. Results: The mean energy intake provided by SLPFs was 33% (SD ± 8), and this figure was 42% (SD ± 13) for normal food and 21% (SD ± 5) for protein substitutes (PS). SLPFs supplied a mean intake of 40% carbohydrate (SD ± 10), 51% starch (SD ± 18), 21% sugar (SD ± 8), and 38% fat (SD ± 13). Fibre intake met 83% of the Scientific Advisory Committee on Nutrition (SACN) reference value, with 50% coming from SLPFs with added gums and hydrocolloids. Low protein bread, pasta and milk provided the highest energy contribution, and the intake of sweet SLPFs (e.g., biscuits, cakes, and chocolate) was minimal. Children averaged three portions fruit/vegetable daily, and children aged ≥ 12 y had irregular meal patterns. Conclusion: SLPFs provide essential energy in phenylalanine restricted diets. Optimising the nutritional quality of SLPFs deserves more attention. Full article