Poor Nutrition
Conditions
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.
Interventions
Per standard of care (SOC)
Sponsors
Abbott Nutrition
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight | Baseline to 12 weeks | Measured weight kg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Hand Grip | Baseline to 12 weeks | Dynamometer |
Countries
India
Outcome results
None listed