Malnutrition
Conditions
Brief summary
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
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)
Interventions
OTHERNutritional beverage 10003RF
2 sachets per day
OTHERDietary Counseling
Guidelines for dietary counseling include energy and nutrient requirements.
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline in Body weight | baseline and weeks 4, 8, 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BMI | baseline and week 12 | — |
| Blood Chemistries (pre-albumin g/L, alpha-1 acid glycoprotein g/L) | baseline and weeks 4,8,12 | values and changes from baseline |
| Nutrition Assessment | baseline and week 12 | — |
| Blood Chemistries (glucose mg/dL, creatinine mg/dL) | Baseline and weeks 4,8,12 | values and changes from baseline |
| Blood Chemistries (c-reactive protein mg/L) | Baseline and weeks 4,8,12 | Values and changes from baseline |
| Blood Chemistries (albumin gm/dL, hemoglobin gm/dL, total protein gm/dL) | baseline and weeks 4, 8, 12 | values and changes from baseline |
Countries
India
Outcome results
None listed