NCT03713463
Terminated
Not Applicable
An Observational, Multicenter Study to Evaluate the Benefits of Regular Intake of Standard ONS in Indian Adults
ConditionsPoor Nutrition
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Poor Nutrition
- Sponsor
- Abbott Nutrition
- Enrollment
- 59
- Locations
- 45
- Primary Endpoint
- Weight
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Weight
Time Frame: Baseline to 12 weeks
Measured weight kg
Secondary Outcomes
- Hand Grip(Baseline to 12 weeks)
- Quality of Life (QoL)(Baseline to 12 weeks)
Study Sites (45)
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