Oral Nutritional Supplementation in Hospital Patients

Study Overview
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Brief Summary
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The study objective is to evaluate the benefits of Oral Nutritional Supplementation (ONS) plus Dietary Counseling (DC) in newly admitted hospital subjects with moderate or severe malnutrition.

Detailed Description
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Approximately 212 subjects (men and women) from multiple Institutions in India will participate in this study. Eligible subjects will be randomized into 2 treatment groups. Dietary Counseling only (n=106) Dietary Counseling + ONS (n=106)

Official Title
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Oral Nutritional Supplementation in Hospital Patients

Conditions
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Malnutrition

Intervention / Treatment
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* Other: Nutritional beverage 10003RF
* Other: Dietary Counseling
* Other: Dietary Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years of age Recently admitted into hospital ≤36 hrs. Identified as having moderate malnutrition or severe malnutrition. Anticipated length of hospital stay of at least 3 days. Life expectancy of ≥ 12 weeks Able to consume foods and beverages orally. Willing to abstain from nutritional supplements throughout the study period unless provided be study. Exclusion Criteria: 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. Diabetes, burn injury covering greater than or equal to 15% of the body, advanced renal or hepatic disease, active malignancy. Ascites, pleural effusion, severe edema or dehydration. Severe edema. Medications/ supplements/substances that could profoundly modulate metabolism or weight Active tuberculosis, acute Hepatitis B or C, or HIV.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary Counseling + ONS<br> | Other: Nutritional beverage 10003RF<br>* 2 sachets per day<br>Other: Dietary Counseling<br>* Guidelines for dietary counseling include energy and nutrient requirements.<br>|
| Active Comparator: Dietary Counseling<br> | Other: Dietary Counseling<br>* Guidelines for dietary counseling include energy and nutrient requirements.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in Body weight |  | baseline and weeks 4, 8, 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutrition Assessment |  | baseline and week 12 | 
| BMI |  | baseline and week 12 | 
| Blood Chemistries (pre-albumin g/L, alpha-1 acid glycoprotein g/L) | values and changes from baseline | baseline and weeks 4,8,12 | 
| Blood Chemistries (albumin gm/dL, hemoglobin gm/dL, total protein gm/dL) | values and changes from baseline | baseline and weeks 4, 8, 12 | 
| Blood Chemistries (glucose mg/dL, creatinine mg/dL) | values and changes from baseline | Baseline and weeks 4,8,12 | 
| Blood Chemistries (c-reactive protein mg/L) | Values and changes from baseline | Baseline and weeks 4,8,12 |