Determination of In-vivo Plasma AA Appearance From Plant Protein Fibre Products
AgingUndernutrition2 moreThis study aims to assess the digestibility and efficacy of the study groups previously developed innovative plant-based protein and fibre products.
Home Fortification of Complementary Foods in Bihar India
AnemiaMalnutritionThis study evaluates the program effectiveness of home fortification along with infant and young child feeding (IYCF) counseling as a strategy to address anemia and complementary feedings gaps in a program setting of the Integrated Family Health Initiative being implemented by CARE India (a non-profit organization) in partnership with the Government of Bihar. The study also seeks to assess the field level worker experience with counseling and dissemination of home fortification products.
Pharmacokinetics of Single and Multiple Escalating Doses of Aramchol Administered Under Fed Conditions...
Healthy VolunteersThis is a single-site, randomized, double-blind, double dummy, placebo-controlled single and multiple doses study of Aramchol in healthy Chinese volunteers. The subject population that was enrolled for Aramchol 004 was not specifically designed to understand the PK profile of Aramchol in subjects of Chinese descent. Therefore, this study (Aramchol 015) has been undertaken to ascertain the PK profile of Aramchol following single and multiple doses in a Chinese population under fed conditions utilizing the light breakfast from Aramchol 004. This study will consist of two parts and the subjects will be assigned to two parts. In each part of the study, subjects will be enrolled in the study within 28 days of screening.
Supplementation With Nutrients Modulating IGF-1 and Cytokines in Elderly People at Risk of Undernutrition...
UndernutritionThe purpose of this study was to determine the improvement in nutritional status, especially in the level of insulin-like growth factor-1 (IGF-1) and its relationship with changes in the circulating cytokine levels, after providing extra protein and energy contents to community-dwelling older adults at risk of undernutrition.
Effect of a New High-protein Oral Supplement on Functional Parameters in Patients in Nursing Homes...
MalnutritionThe objective of this study is to determine whether a supplementation with a new high-protein oral supplement can improve the evolution of functional parameters in elderly patients in nursing homes.
Meals on Wheels, the Effect of a Home Food-delivery Service for Cancer Patients
Lung CancerAmbulant1 moreThe overall objective of the study is to investigate the effect of energy- and protein enriched home delivered meals vs. habitual diet in malnourished patients suffering from cancer on various endpoints.
A Relative Bioavailability Study of Acetaminophen Extended Release Gel Tabs 650 mg Under Fed Condition...
HealthyThe purpose of this study is to compare single-dose oral bioavailability of acetaminophen 650 mg extended release geltabs (containing acetaminophen 650 mg) of OHM Laboratories, USA (subsidiary of Ranbaxy) with Tylenol extended release geltabs (containing acetaminophen 650 mg) of Mc Neil, Consumer & Specialty Pharmaceuticals, U.S.A in healthy, adult, male human subjects under fed condition.
Ready to Use Therapeutic Food (RUTF) in Severe Malnourished Children
Severe Acute MalnutritionRUTF would be more effective (quicker catch-up growth by promoting more tissue accrue resulting decrease stay in rehabilitation ward) in treating children with SAM during the rehabilitation phase than khichuri /halwa; RUTF would be acceptable to the children and their mothers/caregivers; Malnutrition is not caused solely by lack of food, but also by impaired utilization of the food that is ingested. The ability of the gut to absorb nutrients from the diet is associated with the host's 'human' genotype, the host's gut microbiota and its gene content (the microbiome).
Validation of the STAMP Screening Tool For Pediatric Nutritional Risk
MalnutritionBackground: Insufficient nutritional intake, with or without concomitant morbidity, leads to weight loss or insufficient weight gain, is related to an increase in morbidity and mortality and exposes the child to medical complications. In addition, obesity is also related to complications during hospitalization and complications in general, and therefore early identification of these children is extremely important. Studies show that malnutrition is frequent among children upon hospitalization, where the risk of pediatric nutritional deterioration increases, even in the presence of mild stress factors. This risk is frequent mainly among children that arrive at the hospital with an initial poor nutritional status. Improving the nutritional status as part of the standard of care already at the ambulatory setting might improve the prognosis of children when ill. In Israel, nutritional screening in not conducted among children since there is no proper validated screening tool. Study objectives: To test the accuracy of the STAMP Screening Tool for pediatric nutritional risk which is designed to be used by nurses, and to compare it to a complete nutritional assessment conducted by a dietician in Clalit Health Care Services clinics. In addition, the investigators wish to examine the effects of using a screening tool for nutritional risk on the medical staff's attention to the nutritional status; this is measured by the collection of nutritional status-related data and their recording in the patient file. Methods: 100 boys and girls aged 1 to 6, attending Clalit Health Care Services Pediatric Centers, will undergo an assessment using the STAMP Tool; a questionnaire including 3 questions with a summary score, according to which the nutritional risk level shall be determined. These children shall also undergo a complete dietician assessment in order to examine the validity of the STAMP Tool. In addition, 150 files shall be reviewed in the beginning of the research and after 6 months in order to estimate the change in medical staff's attention to nutritional status, by way of noting relevant diagnoses, reference to nutritional status- related tests and recording of anthropometric measurements. A statistical analysis to examine the validity of the STAMP Tool shall be carried out using the kappa test (K) (30). The effect of the STAMP Tool use shall be calculated using the chi square test.
Soy-Ready to Use Therapeutic Food (RUTF) in Severely Malnourished Children
Severe Acute MalnutritionSevere Wasting1 moreSAM defined by having weight-for-height (WH) less than - 3 Z score or bi-pedal nutritional edema is an important cause of death in children globally including Bangladesh. The death rate among children hospitalized for SAM is still high. Severe malnutrition in children can be successfully treated by using WHO guidelines with or without minor modification. Since the Community Based Therapeutic Care (CTC)/CMAM approach was developed, the use of RUTF for the treatment of children with SAM has gained ground, and huge amounts of RUTF are used particularly in African countries. RUTFs are an energy-dense lipid paste enriched with vitamins and minerals. The typical composition (ingredient % of weight) of RUTF is whole milk powder 30%; sugar 28%; vegetable oil 15.4%; peanut paste 25%; and mineral vitamin mix 1.6%. Although the CTC model promises treatment of SAM at a considerably lower cost than the previous inpatient model, the cost of RUTF is still considered a significant barrier to universal roll-out of SAM treatment and has made CTC implementation too expensive in many high-need countries. The single most expensive raw ingredient in RUTF is milk powder, contributing around 50% of raw ingredient cost or between 30-35% of the total cost of the final product. Isolated soy protein has a cost per kg protein that normally is below that of skim or whole milk powder, and can thus reduce the total cost of RUTF. In addition, isolated soy protein (ISP) is a high quality, complete protein that meets the daily protein requirements of growing children and adults. ISP is a highly digestible protein [FAO/WHO, 1991] with an amino acid profile that has been shown to achieve a Protein Digestibility-Corrected Amino Acid Score (PDCAAS) of 1.00, comparable to milk and eggs, and has been shown to maintain nitrogen balance when fed as the sole protein source at minimum recommended intake levels. To compare the efficacy (weight gain, rate of weight gain and change of lean body mass) of the standard RUTF and an RUTF made from ISP (Soy-RUTF) through a randomized double masked intervention trial 300 SAM children aged 6 to 59 months after completion of their stabilization phase from the Dhaka Hospital of icddr,b Bangladesh will be studied. They will randomly receive standard- or Soy-RUTF as take home and followed up (weekly until achieving -2 WHZ, and thereafter fortnightly until achieving -1 WHZ) at the nutrition follow up unit at the outpatient department of this Dhaka Hospital of icddr,b.