Benefits of Standard ONS in Indian Adults
- Conditions
- Poor Nutrition
- Interventions
- Other: Oral Nutritional Supplement (ONS)
- Registration Number
- NCT03713463
- Lead Sponsor
- Abbott Nutrition
- Brief Summary
This is a prospective, single arm, baseline-controlled multicenter study to observe benefits on Oral Nutritional Supplement (ONS) intake in adults with medical conditions associated with poor nutritional status.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 59
- Ambulatory adult patients >or equal to 45 years of age
- Patients at the risk of malnutrition (MST > or equal to 2)
- Patients who understand nature of the study, willing to participate in all scheduled visits and trial procedures & provide a written informed consent.
- Subject using commercially available macronutrient food supplements or another ONS
- History or evidence of hypersensitivity to any component of study product
- History of any Gastrointestinal disorder/surgery that affects digestion and/or absorption of food
- Evidence of active TB, Hepatitis B, Hepatitis C or HIV infection, type 1 or type 2 diabetes mellitus, malignancy and any other disease affecting appetite and weight loss
- History or evidence of any medical condition that in the opinion of Investigator can interfere with the study assessment of outcome or Patients with scheduled surgery during the duration of the study
- Subjects who are unlikely to comply with the study protocol or follow up regularly for study assessments
- Pregnant or lactating women
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Oral Nutritional Supplement (ONS) Oral Nutritional Supplement (ONS) 2 servings per day ONS
- Primary Outcome Measures
Name Time Method Weight Baseline to 12 weeks Measured weight kg
- Secondary Outcome Measures
Name Time Method Hand Grip Baseline to 12 weeks Dynamometer
Quality of Life (QoL) Baseline to 12 weeks World Health Organization QOL-BREF Questionnaire; 4 Domain scores scaled in a positive direction (very dissatisfied - very satisfied)
Trial Locations
- Locations (45)
Dr.Vinay J. Clinic
🇮🇳Bangalore, India
Sri Sai Health Care Center
🇮🇳Bangalore, India
Sree Narayana Nursing Home
🇮🇳Chennai, India
Dr. Sriram V. Clinic
🇮🇳Chennai, India
Goel Clinic
🇮🇳Delhi, India
Jain Clinic
🇮🇳Delhi, India
Subramanyam's Day Care Center
🇮🇳Bangalore, India
Chandra Chest and Diabetes Care Center
🇮🇳Chennai, India
Dr. Srinivasan Clinic
🇮🇳Chennai, India
Dr. Parinata Roy Clinic
🇮🇳Kolkata, India
Dr. S. Vikas Clinic
🇮🇳Mumbai, India
Dr. U. V. Mohan Clinic
🇮🇳Chennai, India
Vcure Clinic
🇮🇳Chennai, India
Dr. A. K. Chatterjee Clinic
🇮🇳Kolkata, India
Dr. Jagdish singh Clinic
🇮🇳Hyderabad, India
Adhiparasakthi Clinic
🇮🇳Chennai, India
Dr. Asoktaru Sengupta Clinic
🇮🇳Howrah, India
Dr. Arabinda Halder Clinic
🇮🇳Kolkata, India
Dr. O. P. Sharma Clinic
🇮🇳Kolkata, India
Qureshi Clinic
🇮🇳Mumbai, India
Contractor Clinic
🇮🇳Mumbai, India
Ajitkumar Clinic
🇮🇳Mumbai, India
Devrukhar Clinic
🇮🇳Thane, India
Pawar Clinic
🇮🇳Thane, India
Vasavi Clinic
🇮🇳Chennai, India
Sow-Krish Clinic
🇮🇳Chennai, India
Sunidhi Health Centre
🇮🇳Bangalore, India
Javantika Clinic
🇮🇳Chennai, India
Prime Family Medical Centre
🇮🇳Chennai, India
Dr. S. Nagrajan Clinic
🇮🇳Chennai, India
Sanjeevan Clinic
🇮🇳Delhi, India
Joshi Clinic
🇮🇳Delhi, India
Sharma Clinic
🇮🇳Delhi, India
Dr. Mridul Bera Clinic
🇮🇳Howrah, India
Geetha Hospital
🇮🇳Hyderabad, India
Maxcure Hospitals
🇮🇳Hyderabad, India
City Clinic
🇮🇳Hyderabad, India
Healthy Lifestyle Clinic, Kolkata
🇮🇳Kolkata, India
Dass Medical Hall
🇮🇳Kolkata, India
Bhulchandani Hospital
🇮🇳Mumbai, India
Gayatri Clinic
🇮🇳Secunderabad, India
Thakkar Clinic
🇮🇳Thane, India
Dhabolkar Clinic
🇮🇳Mumbai, India
Dr. A. Mahadev Clinic
🇮🇳Secunderabad, India
Boricha Clinic
🇮🇳Thane, India