Impact of Oral Nutritional Supplementation in Chronic Kidney Disease Patients on Maintenance Hemodialysis: An Open-label, Single-arm Study among Indian Patients.

BACKGROUND: Protein-energy wasting (PEW) affects about 50-75% of patients with chronic kidney disease (CKD), particularly those who are on maintenance hemodialysis (MHD). This study evaluated the efficacy and tolerability of an oral nutritional supplement in Indian patients receiving MHD. MATERIALS AND METHODS: This was a 3-month, prospective, open-label, and single-centered study. Eligible participants supplemented their regular diet with one sachet (40 gm) of oral nutritional supplement powder twice daily for 90 days. The study efficacy endpoints were mean change in acute phase proteins (albumin and prealbumin), anthropometric measurements [weight, body mass index (BMI), and triceps skin fold thickness], handgrip strength, hemoglobin, total iron binding capacity (TIBC), potassium, and phosphorus levels, malnutrition score (MS)-modified subjective global assessment (modified SGA), malnutrition inflammation score (MIS), and nutritional status. RESULTS: The study population comprised 36 (42.9%) men and 48 (57.1%) women with a mean age of 54.85 ± 15.50 years. A paired sample t-test was used to compare the baseline with end-of-study values for continuous variables. Serum albumin, prealbumin, hemoglobin, and phosphorus levels remained stable throughout the study period. The mean change in weight, BMI, triceps skin fold thickness, handgrip strength, and TIBC for the overall study population was 1.11 kg (1.82%, p < 0.0001), 0.46 kg/m2 (1.98%, p < 0.0001), 3.47 mm (30.78%, p < 0.0001), 6.05 kg (44.98%, p < 0.0001) and 11.80 µg/dL (6.06%, p < 0.0001), respectively. At the end of the study period, there was a significant (p < 0.0001) improvement in the SGA and MIS scores. Further, there was a significant improvement in nutritional status as demonstrated by the overall intake of calories (p < 0.001), proteins (p < 0.0001), carbohydrates (p = 0.003, and fats (p < 0.0001). CONCLUSION: Protein-energy malnutrition is a strong predictor of morbidity, mortality, and poor outcomes in CKD patients. A scientifically designed formula in accordance with KDOQI standards was able to improve the nutritional status, overall body composition, sarcopenia, and quality of life in CKD patients on MHD.

Efficacy of optimal nutraceutical combination in treating PCOS characteristics: an in-silico assessment.

BACKGROUND: Polycystic ovary syndrome (PCOS) is a serious health condition affecting women of reproductive age. High prevalence of PCOS and associated metabolic complications needs effective treatment and management. This study evaluated the efficacy of optimal nutraceutical combinations in improving PCOS characteristics using system biology-based mathematical modelling and simulation. METHODS: A shortlisting of eight potent nutraceuticals was carried out with literature search. Menstrual cycle model was used to perform simulations on an in-silico population of 2000 individuals to test individual and combined effects of shortlisted nutraceuticals on five PCOS characteristics [oligomenorrhea, anovulation, hirsutism, infertility, and polycystic ovarian morphology (PCOM)] for a duration of 6 months. Efficacy was tested across lean and obese phenotypes and age groups. RESULTS: Individual assessment of nutraceuticals revealed seven most potent compounds. Myo-inositol among them was observed to be the most effective in alleviating the PCOS characteristics. The in-silico population analysis showed that the combination of melatonin and ALA along with myo-inositol was efficacious in restoring the hormonal balance across age-groups and Body Mass Index (BMI) categories. CONCLUSION: Supplementation with the combination of myo-inositol, melatonin, and ALA demonstrated potential in managing PCOS symptoms in our in-silico analysis of a heterogeneous population, including lean and obese phenotypes across various severities and age groups, over a 6-month period. Future clinical studies are recommended to validate these findings.

Investigating Bioavailability of Curcumin and Piperine Combination in Comparison to Turmeric Rhizomes: An in vitro Study.

Purpose: To assess the permeability of the test item (a combination of curcumin and piperine) and a reference item (dried and crushed turmeric rhizomes) using a combination of Caco-2 cell monolayer permeability assay and liquid chromatography-tandem mass spectrometry. Methodology: In the Caco-2 cell assay, a transport buffer was prepared, and stock solutions of test and reference items were made. Caco-2 cells were cultured on transwell plates. Permeability assays were conducted for 2 and 6 hours, followed by post-experiment testing for assessing the monolayer integrity. LC-MS/MS (Liquid Chromatography with tandem mass spectrometry) analysis was performed to calculate apparent permeability of each item. Results: The test item was undetectable at the end of 2 hours of permeability assay. Further, after 6 hours of permeability assay, the permeability of both test and reference item was found to be low. Conclusion: The results showed that the curcumin and piperine combination had low permeability of curcumin in vitro as compared to the dried and crushed turmeric rhizomes. This could predict the low bioavailability of curcumin in vivo when co-administered with piperine.

Effect of a High-Protein High-Fibre Nutritional Supplement on Lipid Profile in Overweight/Obese Adults with Type 2 Diabetes Mellitus: A 24-Week Randomized Controlled Trial.

BACKGROUND: Foods rich in protein and dietary fibre could potentially improve lipid profile in overweight or obese diabetic patients with dyslipidemia and, thereby, mitigate their risk of cardiovascular disease (CVD). In this study, the effect of providing high-protein high-fibre (HPHF) nutritional supplement in addition to standard care of type 2 diabetes mellitus (T2DM) on lipid profile was evaluated. METHODS: In this open-label, parallel-arm, prospective, randomized study, a total of 100 overweight/obese participants with T2DM were randomized to either an intervention group (25 g HPHF nutritional supplement given twice daily along with a standard care of T2DM) or a control group (standard care of T2DM) for 24 weeks. Change from baseline in lipid parameters such as total cholesterol (TChol), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and triglycerides (TG) was assessed between the intervention and control group at week 12 and week 24. Participant compliance was assessed using the dietary 24-hour recall. Statistical analysis was performed to assess the main effects on within- and between-group changes from baseline to end of 24 weeks. RESULTS: Participants in the HPHF nutritional supplement group showed a statistically significant improvement in HDL-C levels by the end of 24 weeks (p=0.04) and a significant increase in protein and total dietary fibre intake (p=0.002 and p=0.00, respectively) compared to the control group. The TChol/HDL-C ratio was significantly lower (p=0.03) in the HPHF group from baseline to 24 weeks. CONCLUSION: Twice-daily consumption of a HPHF nutritional supplement significantly improved HDL-C levels. Inclusion of the HPHF supplement would be a useful effective aid for managing dyslipidemia in overweight/obese individuals with T2DM.

Effect of deworming vs Iron-Folic acid supplementation plus deworming on growth, hemoglobin level, and physical work capacity of schoolchildren.

The effect of deworming vs deworming and weekly Iron-Folic acid (IFA) on growth, hemoglobin level, and physical work capacity of children was studied. Children from three rural schools studying from 4th to 7th standard were selected. One set of school children were given deworming tablet (400 mg albendezole) once in six months while the second school children received deworming tablet along with weekly dose of Iron Folic acid Tablet (60 mg of elemental iron and 0.5 mg folic acid). Anthropometric measurements, hemoglobin, and physical work capacity was estimated. No significant change was noticed in the prevalence of malnutrition or physical work capacity of the children. As compared to only deworming, IFA + Deworming showed 17.3% increase in the hemoglobin levels (P<0.001). Thus weekly IFA along with deworming has shown beneficial effect on the hemoglobin levels of the children.