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 oral nutritional supplementation on growth and recurrent upper respiratory tract infections in picky eating children at nutritional risk: a randomized, controlled trial.

Objectives To evaluate the effect of oral nutritional supplementation (ONS) plus dietary counselling (DC) (intervention) versus DC alone (control) on growth and upper respiratory tract infection (URTI) in nutritionally at-risk, picky eating children in India. Methods We performed a 90-day, prospective, randomized, controlled trial. A total of 255 children aged 24-72 months with a weight-for-age z-score ≥-2 and <-1, picky eating behaviour, and acute URTI were randomized to the control (n = 128) or intervention group (n = 127). The outcomes included the change in weight-for-age z-score from days 1 to 90 and the URTI incidence. Results The mean age was 44.0 ± 14.3 months. The intervention group showed a significantly greater increase in mean weight-for-age and body mass index-for-age z-scores compared with the control group from day 10 onwards. Higher energy intake in the intervention group was observed at all follow-up visits, except for day 10. The incidence of URTI in the control group was 2.01 times higher than that in the intervention group, controlling for confounding factors. Conclusions ONS plus DC is effective for improving weight and reducing the incidence of URTI in nutritionally at-risk, picky eating children with an acute URTI episode.

Continuation of oral nutritional supplementation supports continued growth in nutritionally at-risk children with picky eating behaviour: A post-intervention, observational follow-up study.

Objectives To evaluate the 120-day post-intervention growth trajectory of picky-eating children aged 2 to 6 years who previously completed a 90-day, randomized, controlled trial of oral nutritional supplementation (ONS) plus dietary counselling (DC) (SDC, n = 98) compared with DC alone (n = 105). Methods A total of 203 children were included. Children were free to consume ONS during follow-up. Information on ONS consumption was collected. Weight-for-age percentile (WAP) and height-for-age percentile (HAP) were measured at Day 90 (beginning) and Day 210 (end point). Results Despite continued weight gain, there was a significant decline in WAP in both groups during the post-intervention period. However, children who took ONS voluntarily had a smaller loss in WAP compared with those who did not. Children in the SDC group showed no difference in a decline in HAP between those who took ONS during follow-up and those who did not. However, children in the DC group showed a marginally larger decline in HAP in those who did not take ONS during the follow-up compared with those who did. Conclusions Continued parental self-administration of ONS to their children slows down the loss of growth percentiles, supporting continued weight gain in picky-eating children at nutritional risk.

A pilot study to assess the utility and perceived effectiveness of a tool for diagnosing feeding difficulties in children.

BACKGROUND: Food dislikes in children may result in avoiding particular food/s with major sources of essential nutrients leading to increased risk of impaired growth or cognitive development and compromised immune function. It is necessary to identify conditions contributing to feeding difficulty and associated complications. An instrument was designed to assist diagnosis and management of children with feeding difficulties. The study was conducted to test utility of the "Identification and Management of Feeding Difficulties (IMFeD)" tool in Indian children. METHODS: A prospective, cross-sectional study was conducted in Indian children between 2 and 10 years identified to have picky eating behaviour. After completion of both pro forma sections (parent and physician) of the IMFeD tool, the child's specific feeding difficulty was diagnosed and appropriate nutritional and/or behavioural counselling was provided. The subjects were followed at 30 and 60 days post-intervention. RESULTS: According to 66% of paediatricians the IMFeD tool was very easy to use. Approximately 85% of paediatricians required ≤20 min to administer the tool, diagnose the feeding difficulty(ies) and provide specific counselling or behavioural management. More than 70% of parents were satisfied and willing to accept the use of the IMFeD tool. After 60 days, 65% of the parents were either less worried or not worried at all about the feeding behaviour of the child using recommendations made on the basis of the IMFeD tool. The toolkit helped parents to know what to do if their child had a feeding problem. A total of 90% of the parents expressed that the tool is useful for assessing feeding difficulties in children. CONCLUSION: The IMFeD tool can be effectively used to identify feeding difficulties in Indian children. This toolkit also helps to offer nutritional and behavioural guidance as a part of the management.