Intervention With Oral Nutritional Supplement (ONS) for the Patient With or at Risk of Malnutrition
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Malnutrition
- Sponsor
- Chinese University of Hong Kong
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- body weight
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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 of protein energy malnutrition in patients has been reported. A close relation between malnutrition and re-admission rate, cost of hospital care in terms of length of stay in hospital as well as mortality has been documented. A Cochrane review of the use of oral nutritional supplementation suggested that oral nutrition not only provided nutrients, but also has significant improvements on psychological and social functions, possibly through enhancing sensation of taste and flavor which is an important mediator of pleasure and well-being. Therefore, an oral option of nutrition is always considered as the first choice of nutritional intervention, in particular in situations where nutritional interventions, such as assisted feeding, are difficult, time-consuming and demanding due to advanced morbidity and slow responses. In this randomized controlled trial, the investigators will explore the gaps of nutritional needs and the potential use of nutrition supplementation in the management of malnutrition among patients in Hong Kong. The investigators aim to improve the nutrient intakes and the nutritional status of participants through a specially formulated oral nutrition supplement titled "Fresubin® Powder Fibre" to reverse malnutrition status due to acute and chronic illness. Fresubin® Powder Fibre is a nutritionally complete powder product to be reconstituted in different caloric densities (1.0 to 1.5 kcal/ml) and containing high quality protein and vitamin D for the dietary management of participants with or at the risk of malnutrition.
Investigators
Timothy Kwok
professor
Chinese University of Hong Kong
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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)
Outcomes
Primary Outcomes
body weight
Time Frame: 12 weeks
Change in body weight
Secondary Outcomes
- Body Mass Index(12 weeks)
- calf circumference(12 weeks)
- SF-12 Health Survey(12 weeks)
- Mini Nutritional Assessment-short form(MNA-SF)(12 weeks)
- mid-arm circumference (MAC)(12 weeks)
- Self-rated health(12 weeks)
- 5-item FRAIL scale(12 weeks)
- 3-day dietary record(12 weeks)