Health Condition 1: null- To evaluate the benefits of ONS plus Dietary Counseling (DC) in newly admitted hospital subjects with moderate or severe malnutrition.
Conditions
Interventions
Intervention1: Oral Nutritional Supplementation (ONS) + Dietary Counseling (DC): 12 weeks
Control Intervention1: Dietary Counseling (DC): 12 weeks
Sponsors
Abbott Nutrition
Abbott Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Subject 1.Is greater than or equal 18 years of age 2.Is recently admitted into hospital less than or equal to 36 hrs. 3.Identified as having moderate malnutrition or severe malnutrition. 4.Has anticipated length of hospital stay of at least 3 days. 5.Has a life expectancy of grater than or equal to 12 weeks 6.Is able to consume foods and beverages orally. 7.Is willing to abstain from additional non-study provided protein supplements or nutritional supplements throughout the study period
Exclusion criteria
Exclusion criteria: Subject 1.has alcohol or substance abuse, severe dementia, brain metastases, eating disorders or any psychological condition that may interfere with dietary intake, severe nausea, dysphagia, vomiting, diarrhea, active gastritis, gastrointestinal bleeding or other gastrointestinal disturbances, in the opinion of the Study Physician, at study entry. 2.has a diagnosis of diabetes, burn injury covering greater than or equal to 15% of the body, advanced renal or hepatic disease (including cirrhosis), active malignancy, including melanoma and excluding cutaneous malignancies (e.g., basal cell carcinoma, squamous cell carcinoma and carcinoma of the cervix). 3.has clinically significant ascites, pleural effusion, severe edema or dehydration as determined by a physician. 4.Severe edema is defined as Stage 4. 5.is currently taking medications/ supplements/substances that could profoundly modulate metabolism or weight (e.g. diuretics, appetite stimulants, progestational agents, steroids, growth hormone, dronabinol, marijuana, or other anabolic agents). 6.Exceptions: Inhaled steroids for asthma or chronic obstructive pulmonary disease will be allowed. Topical or optical steroids will also be allowed. In addition, stable doses of steroids or diuretics taken for greater than or equal to 6 weeks prior to hospitalization and maintains the stable dosage for the duration of the study will be allowed. 7.has active tuberculosis, acute Hepatitis B or C, or HIV (per documentation in the medical record).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body WeightTimepoint: at base line, weeks 4, 8 and12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Nutrition Assessment,BMI and Blood ChemistriesTimepoint: Nutrition Assessment and BMI at baseline and week 12 and Blood Chemistries at baseline and weeks 4,8,12 | — |
Countries
India
Contacts
Public ContactDilip Nair Manager CRO
Head MedicalANI
Outcome results
None listed