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.
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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
212
2 sachets per day
Guidelines for dietary counseling include energy and nutrient requirements.
Guidelines for dietary counseling include energy and nutrient requirements.
King George Hospital / Andhra Medical College
Andhra Pradesh, India
St. Theresa's Hospital
Andhra Pradesh, India
Care Hospital- Hyderabad
Hyderabad, India
Changes from baseline in Body weight
Time frame: baseline and weeks 4, 8, 12
Nutrition Assessment
Time frame: baseline and week 12
BMI
Time frame: baseline and week 12
Blood Chemistries (pre-albumin g/L, alpha-1 acid glycoprotein g/L)
values and changes from baseline
Time frame: baseline and weeks 4,8,12
Blood Chemistries (albumin gm/dL, hemoglobin gm/dL, total protein gm/dL)
values and changes from baseline
Time frame: baseline and weeks 4, 8, 12
Blood Chemistries (glucose mg/dL, creatinine mg/dL)
values and changes from baseline
Time frame: Baseline and weeks 4,8,12
Blood Chemistries (c-reactive protein mg/L)
Values and changes from baseline
Time frame: Baseline and weeks 4,8,12
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Advanced Medicare and Research Institute
Kolkata, India
Sengupta Hospital & Research Institute
Maharashtra, India
Lokmanya Tilak Muncipal Medical College & Lokmanya Thilak Municipal General Hospital
Mumbai, India
Seth GS Medical College and KEM Hospital
Mumbai, India
TN Medical College & BYL Nair Hospital
Mumbai, India
Abhinav Hospital
Nagpur, India
Sir Ganga Ram Hospital
New Delhi, India
...and 3 more locations