Benefits of Standard ONS in Indian Adults
- Registration Number
- CTRI/2019/05/018917
- Lead Sponsor
- Abbott Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Ambulatory adult patients >or equal to 45 years of age
2. Patients at the risk of malnutrition (MST > or equal to 2)
3. Patients who understand nature of the study, willing to participate in all scheduled visits and trial procedures & provide a written informed consent.
1. Subject using commercially available macronutrient food supplements or another ONS
2. History or evidence of hypersensitivity to any component of study product
3. History of any Gastrointestinal disorder/surgery that affects digestion and/or absorption of food
4. 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
5. 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
6. Subjects who are unlikely to comply with the study protocol or follow up regularly for study assessments
7. Pregnant or lactating women
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Measured weight kgTimepoint: Baseline to 12 weeks
- Secondary Outcome Measures
Name Time Method Hand Grip- DynamometerTimepoint: Baseline to 12 weeks;Quality of Life: WHOQOL-BREFTimepoint: Baseline to 12 weeks