Fat-rich versus carbohydrate-rich nutrition in ALS: a randomised controlled study

ObjectiveThere is growing evidence that the course of amyotrophic lateral sclerosis (ALS) may be influenced beneficially by applying high-caloric food supplements (HCSs). However, it is unknown which composition of nutrients offers optimal tolerability and weight gain.MethodsWe conducted a randomised controlled study (Safety and Tolerability of Ultra-high-caloric Food Supplements in Amyotrophic Lateral Sclerosis (ALS); TOLCAL-ALS study) in 64 patients with possible, probable or definite ALS according to El Escorial criteria. Patients were randomised into four groups: a high-caloric fatty supplement (HCFS; 405 kcal/day, 100% fat), an ultra-high-caloric fatty supplement (UHCFS; 810 kcal/day, 100% fat), an ultra-high-caloric, carbohydrate-rich supplement (UHCCS; 900 kcal/day, 49% carbohydrates) and an open control (OC) group without any supplement. The primary endpoint was tolerability. Patients were followed up over 4 weeks.ResultsGastrointestinal side effects were most frequent in the UHCFS group (75.0%), while loss of appetite was most frequent in the UHCCS group (35.3%). During intervention, patients gained +0.9 kg/month of body weight (IQR −0.9 to 1.5; p=0.03) in the HCFS group and +0.9 kg/month (IQR −0.8 to 2.0; p=0.05) in the UHCFS group. A non-significant trend for weight gain (+0.6 kg/month (IQR −0.3 to 1.9; p=0.08)) was observed in the UHCCS group. Patients in OC group continued to lose body weight (−0.5 kg/month, IQR −1.4 to 1.3; p=0.42).InterpretationThe findings suggest that HCSs frequently cause mild to moderate tolerability issues in patients with ALS, most notably gastrointestinal symptoms in high-fat supplements, and loss of appetite in high-carbohydrate supplements. All three HCSs tested are suited to increase body weight.

Discrimination of Adulterated Ginkgo Biloba Products Based on 2T2D Correlation Spectroscopy in UV-Vis Range

Ginkgo biloba is a popular medicinal plant widely used in numerous herbal products, including food supplements. Due to its popularity and growing economic value, G. biloba leaf extract has become the target of economically motivated adulterations. There are many reports about the poor quality of ginkgo products and their adulteration, mainly by adding flavonols, flavonol glycosides, or extracts from other plants. In this work, we developed an approach using two-trace two-dimensional correlation spectroscopy (2T2D COS) in UV-Vis range combined with multilinear principal component analysis (MPCA) to detect potential adulteration of twenty G. biloba food supplements. UV-Vis spectral data are obtained for 80% methanol and aqueous extracts in the range of 245–410 nm. Three series of two-dimensional correlation spectra were interpreted by visual inspection and using MPCA. The proposed relatively quick and straightforward approach successfully differentiated supplements adulterated with rutin or those lacking ginkgo leaf extract. Supporting information about adulteration was obtained from the difference between the DPPH radical scavenging capacity of both extracts and from chromatographic (HPLC-DAD) fingerprints of methanolic samples.

The Usefulness of X-ray Diffraction and Thermal Analysis to Study Dietary Supplements Containing Iron

X-ray powder diffraction (XRPD) and thermal analysis (differential scanning calorimetry/derivative of thermogravimetry (DSC/DTG)) are solid-state techniques that can be successfully used to identify and quantify various chemical compounds in polycrystalline mixtures, such as dietary supplements or drugs. In this work, 31 dietary supplements available on the Polish market that contain iron compounds, namely iron gluconate, fumarate, bisglycinate, citrate and pyrophosphate, were evaluated. The aim of the work was to identify iron compounds declared by the manufacturer as food supplements and to try to verify compliance with the manufacturer’s claims. Studies performed by X-ray and thermal analysis confirmed that crystalline iron compounds (iron (II) gluconate, iron (II) fumarate), declared by the manufacturers, were present in the investigated dietary supplements. Iron (II) bisglycinate proved to be semi-crystalline. However, depending on the composition of the formulation, it was possible to identify this compound in the tested supplements. For amorphous iron compounds (iron (III) citrate and iron (III) pyrophosphate), the diffraction pattern does not have characteristic diffraction lines. Food supplements containing crystalline iron compounds have a melting point close to the melting point of pure iron compounds. The presence of excipients was found to affect the shapes and positions of the endothermic peaks significantly. Widening of endothermic peaks and changes in their position were observed, as well as exothermic peaks indicating crystallization of amorphous compounds. Weight loss was determined for all dietary supplements tested. Analysis of the DTG curves showed that the thermal decomposition of most food supplements takes place in several steps. The results obtained by a combination of both simple, relatively fast and reliable XRPD and DSC/DTG methods are helpful in determining phase composition, pharmaceutical abnormalities or by detecting the presence of the correct polymorphic form.

Vitamin D in Food Supplements: Labeling Survey

An adequate vitamin D (vitD) intake (Recommended Daily Allowance,RDA= 5µg) is crucial for health maintenance and its deficiency isassociated with several health problems. The increase in hypovitaminosisD cases and the proliferation of food supplements (FS) that are easilyaccessible by the population, have led to an unrestrained chronicconsumption of FS. VitD may accumulate in the body and originatetoxicity (Tolerable Upper Limit, UL=100 µg). The aim of this study was toevaluate if daily vitD doses mentioned in FS labels are in conformity withRDA. 210 solid and liquid FS (for pediatrics and adults) sold in Portuguesepharmacies, supermarkets, health shops and on the internet were examinedfor indicated daily intake of vitD and compared to RDA and UL values.51.43% of FS have values higher than RDA, 8.57% higher than UL. Theaverage vitD daily dose in FS is 24.48 µg, with a high variability betweensamples (0.25 - 250 µg). Majority of FS labels recommend vitD daily dosesabove RDA and some even above UL, regardless of being for adults orchildren. Therefore, it is crucial that vitD dose in FS is reviewed to ensurethe safety of these products.

Risk Assessment of RYR Food Supplements: Perception vs. Reality

Thirty-seven red yeast rice (RYR) food supplements were screened for their mycotoxin and natural statin content. Products included pure RYR capsules and multi-ingredient formulations with standardized amounts of monacolin K (MK), marketed both online and retail in the European Union. In terms of mycotoxins, citrinin (CIT) was found in all the monitored products. As CIT content ranged from 100 to 25100 μg/kg, only four products were compliant with maximum EU levels in force until April 2020, while a single product was compliant with the limit of 100 μg/kg introduced after that date. Four contaminated products were labeled as “citrinin free”. In terms of natural statins, nine products had a lower content vs. label statements (from −30 to −83%), while for 24 a larger MK amount (from 10 to 266%) was noticed. Three products had a negligible MK content and only 19 offered a daily dosage exceeding 10 mg as dictated by the health claim granted by EFSA in the EU. No sample had label values compliant with pharmaceutical Good Manufacturing Practices requirements (95–105% content of active constituent). Variable, but small amounts of simvastatin (0.1–7.5 μg per daily dose) were found in 30 samples. These results suggest that limited efficacy and reported safety issues may stem from an under-regulated and undercontrolled market, weakening both effectiveness and risk assessment evaluations.

Rationale for using nutrient complexes with vitamin and mineral compositions in rehabilitation schemes for patients who have undergone viral infections (literature review)

The results of the previous studies have shown that the use of nutrient complexes with vitamin and mineral compositions in rehabilitation schemes for patients who have undergone viral infections, including COVID-19, is an important link in rehabilitation measures and post COVID-19. The article pathogenetically substantiates the use of biologically active food supplements containing vitamins A, D3, E, C, B1, B2, B3, B5, B6, folic acid, zinc, vanadium, catechins, proanthocyanidins, flavonoids and glycyrrhizic acid.

Utilization of agro-industrial by-products in Monascus fermentation: a review

The Monascus fermentation industry has gained global attention. Its key products, i.e., pigments, functional food ingredients, food supplements, and medicinal use, are growing in the world’s market. Efforts to find the cost-effective substrate for Monascus fermentation have remained the target. This paper aimed to appraise the utilization of agro-industrial by-products (cereal, starchy tuber and root, legume, fruit, and coffee processing) as a cost-effective substrate for Monascus fermentation. The specific objective was to review the by-products pre-treatment, the fermentation process, product yield, and the bioactivity of the fermented products. Among all the by-products that could be used as the fermentation substrate, cereal brans do not need pre-treatment, but others need a suitable pre-treatment step, e.g., cassava peel, okara, and jackfruit seed to list a few, that need to be powdered beforehand. Other substrates, such as corn cob and durian seed, need soaking and size reduction through the pre-treatment step. During fermentation, Monascus produce many pigments, monacolin K, associated with rise in phenolic and flavonoid contents. These products possess antioxidant, antihypercholesterol, antidiabetes, and antiatherosclerosis activities which underpin their health significance. In conclusion, we report in this review the agro-industrial by-products which have potential prospects for pigments, functional food ingredients, food supplements, and therapeutic usages produced from Monascus fermentation.

Effectiveness of community-based treatment programs for treatment of uncomplicated severe acute malnourished children aged 6–59 months using locally produced nutrient dense foods: protocol for a multicentric longitudinal quasi-experimental study

Background Severe acute malnutrition (SAM) is a major underlying cause of mortality among children. Around one third of the world’s acutely malnourished children live in India. The WHO recommends community-based management of acute malnutrition (CMAM) for managing children with SAM. In India, different states are implementing community-based SAM treatment programme, hereinafter called CSAM, using varieties of locally produced nutrient dense food items with different nutrient compositions. The study will assess the effectiveness of these state specific CSAM interventions. Methods The longitudinal quasi-experimental study will be undertaken in two purposively selected blocks of one district each in the four intervention states and one comparison state. From each state, 200 SAM children identified using weight-for-length/height z-score (WHZ) < − 3 criteria will be enrolled in the study. Their anthropometric data and skinfold thickness will be taken on admission, at sixth week and at discharge by trained field investigators. Other child details, incidence of morbidity and socio-economic details will be collected on admission. To assess food consumption pattern including consumption of locally produced nutrient dense food supplements, dietary assessment, using 24-h dietary recall will be conducted on admission, at sixth week and at discharge. In addition, body composition parameters will be assessed for a sub-set of children using bio-electrical impedance analysis on admission and at discharge to analyse changes in total body water, fat-free mass, and fat mass. Post discharge, all study participants will be followed up monthly until 6 months. Atleast 10% of the sample will be checked for quality assessment. The study’s primary outcome is cure rate defined as children attaining WHZ ≥ -2. Secondary outcomes include mean weight gain, mean length of stay, body composition parameters, relapse and mortality rates. Additionally, process evaluation and cost effectiveness analysis will be conducted. Discussion There is a shortage of robust evidence regarding the effectiveness of locally produced nutrient dense food supplements provided as part of the CSAM intervention in India. This study will contribute to evidence on effective strategies to manage children with uncomplicated SAM in India. The study protocol has all necessary ethical approvals. Written informed consent will be obtained from caregivers of the children. Trial registration The study is registered with Clinical Trial Registration of India (Registration No.: CTRI/2020/09/028013) Date of registration 24/09/2020.