Status:
COMPLETED
Oral Nutritional Supplement for the Patient With or at Risk of Malnutrition
Lead Sponsor:
Chinese University of Hong Kong
Collaborating Sponsors:
Fresenius Kabi
Conditions:
Malnutrition
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In case of acute and chronic illness nutritional problems are widespread, and a reduced dietary intake in combination with effects of catabolic disease rapidly lead to malnutrition. A high prevalence ...
Eligibility Criteria
Inclusion
- Chinese origin aged 18 or above
- Normally reside in Hong Kong
- Could speak and understand Chinese
- Being screened as malnourished or at risk of malnutrition using the Mini Nutritional Assessment-Short Form (MNA-SF) with a score at 11 or below
- Willing to follow the study procedures
- Written informed consent form
Exclusion
- Recent (i.e. past 3 months) or concurrent participation in any clinical trial or dietary intervention program
- Self-reported allergy or intolerance to the ingredients of the nutrition supplement
- Consumption of additional ONS, tube feeding or parenteral nutrition
- Use of medications (Amphetamine and its derivatives, Levothyroxine, Biguanides) that could affect study outcomes
- With cancer conditions that are currently undergoing treatment
- Poorly controlled or unstable chronic obstructive pulmonary disease
- Poorly controlled or unstable cardiovascular disease or diabetes or hypertension
- Recent unhealed bone fracture (within the past 12 months)
- Existing gastrointestinal (GI) diseases or pathological findings, which do not allow enteral feeding, e.g. intestinal atony, ileus, acute upper GI bleeding, shock, or malabsorption, e.g. inflammatory bowel disease, pancreatic disease, or previous surgical GI resection
- Severely impaired gastrointestinal function, i.e. severe constipation or acute diarrhea (≥ 3 loose or watery stools per day)
- Dysphagia or high aspiration risk
- Long-term bedridden
- Liver failure or severe renal insufficiency (i.e. significant renal impairment at eGFR of \<30 ml/min, or significant liver impairment as indicated by ALT\>100 or history of liver cirrhosis) in the past 3 months before enrollment
- Relevant central nervous system and/or psychiatric disorders, i.e. Stroke, Alzheimer's disease, Parkinson's disease, traumatic brain injury, depression or other mood disorders
- Planned surgery or hospitalization during study period
- With any other indication of a major medical or psychological illness, as judged by the investigators as ineligible to participate the study
Key Trial Info
Start Date :
November 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 24 2022
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT04474886
Start Date
November 15 2020
End Date
February 24 2022
Last Update
October 7 2022
Active Locations (1)
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1
The Chinese University of Hong Kong
Hong Kong, Hong Kong