Oral Nutritional Supplement for the Patient With or at Risk of Malnutrition
Primary Purpose
Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Fresubin® powder fibre
Sponsored by
About this trial
This is an interventional treatment trial for Malnutrition
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)
- 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
Sites / Locations
- The Chinese University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Fresubin® powder fibre
Usual diet
Arm Description
2 servings of Fresubin® powder fibre per day as supplement to normal diet
Maintain usual diet
Outcomes
Primary Outcome Measures
body weight
Change in body weight
Secondary Outcome Measures
Body Mass Index
Change in Body Mass Index. Height will be measured twice to the nearest 0.1 cm and body weight will be measured twice to the nearest 0.1 kg. BMI will be calculated as body weight in kg / (height in m)2.
Mini Nutritional Assessment-short form(MNA-SF)
Change in MNA-SF would be used to examine the nutritional status of the participants. The scale of this test would be 0 to 14. Malnutrition or at risk of malnutrition will be classified as having a score of 11 or below. Score of 12-14 would be defined as normal nutritional status.
SF-12 Health Survey
Health-related quality of life will be measured with the validated Chinese version of SF-12, which includes physical and mental domains. Physical and Mental Health Composite Scores are computed using the scores of twelve questions and range from 0 to 100. Higher score indicates better health-related quality of life in both domains.
Self-rated health
Self-rated health will be elicited by a single question, "Generally speaking, how is your health: excellent, very good, good, fair, or poor?"The scale would 1 to 5 and a lower score indicates worse self-rated health in this study.
5-item FRAIL scale
The 5-item FRAIL scale will be measured.A score of 1 is assigned to each of the five components: fatigue, resistance (i.e. inability to climb up 10 steps), ambulation (i.e. inability to walk two to three blocks), having more than five diseases, and recent weight loss of more than 5%. Frailty scores range from 0 to 5 and represent frail (3 to 5), pre-frail (1 to 2), and robust (0) health status.
3-day dietary record
3-day dietary record will be used to capture dietary intake for 3 days. The days of recording will be randomly assigned so that all days of the week, including weekend days, will be equally represented. Instructions about recording type of foods and how to estimate the portion sizes in household measures will be given. On the scheduled visit, the trained personnel will check the dietary records for completeness, obtain additional information about unclear items or amounts, and use examples of household measures to improve the estimation. The daily nutrient intake will be calculated by the Food Processor Nutrition analysis and Fitness software version 8.0 (ESHA Research, Salem, USA), with addition of composition of local foods based on food composition table from China and Hong Kong. Change in diet quality in terms of energy intake would be measured as outcome.
mid-arm circumference (MAC)
change of MAC in cm
calf circumference
change of calf circumference in cm
Full Information
NCT ID
NCT04474886
First Posted
July 9, 2020
Last Updated
October 6, 2022
Sponsor
Chinese University of Hong Kong
Collaborators
Fresenius Kabi
1. Study Identification
Unique Protocol Identification Number
NCT04474886
Brief Title
Oral Nutritional Supplement for the Patient With or at Risk of Malnutrition
Official Title
Intervention With Oral Nutritional Supplement (ONS) for the Patient With or at Risk of Malnutrition
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 15, 2020 (Actual)
Primary Completion Date
February 24, 2022 (Actual)
Study Completion Date
February 24, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
Fresenius Kabi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fresubin® powder fibre
Arm Type
Experimental
Arm Description
2 servings of Fresubin® powder fibre per day as supplement to normal diet
Arm Title
Usual diet
Arm Type
No Intervention
Arm Description
Maintain usual diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Fresubin® powder fibre
Intervention Description
2 servings per day
Primary Outcome Measure Information:
Title
body weight
Description
Change in body weight
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Body Mass Index
Description
Change in Body Mass Index. Height will be measured twice to the nearest 0.1 cm and body weight will be measured twice to the nearest 0.1 kg. BMI will be calculated as body weight in kg / (height in m)2.
Time Frame
12 weeks
Title
Mini Nutritional Assessment-short form(MNA-SF)
Description
Change in MNA-SF would be used to examine the nutritional status of the participants. The scale of this test would be 0 to 14. Malnutrition or at risk of malnutrition will be classified as having a score of 11 or below. Score of 12-14 would be defined as normal nutritional status.
Time Frame
12 weeks
Title
SF-12 Health Survey
Description
Health-related quality of life will be measured with the validated Chinese version of SF-12, which includes physical and mental domains. Physical and Mental Health Composite Scores are computed using the scores of twelve questions and range from 0 to 100. Higher score indicates better health-related quality of life in both domains.
Time Frame
12 weeks
Title
Self-rated health
Description
Self-rated health will be elicited by a single question, "Generally speaking, how is your health: excellent, very good, good, fair, or poor?"The scale would 1 to 5 and a lower score indicates worse self-rated health in this study.
Time Frame
12 weeks
Title
5-item FRAIL scale
Description
The 5-item FRAIL scale will be measured.A score of 1 is assigned to each of the five components: fatigue, resistance (i.e. inability to climb up 10 steps), ambulation (i.e. inability to walk two to three blocks), having more than five diseases, and recent weight loss of more than 5%. Frailty scores range from 0 to 5 and represent frail (3 to 5), pre-frail (1 to 2), and robust (0) health status.
Time Frame
12 weeks
Title
3-day dietary record
Description
3-day dietary record will be used to capture dietary intake for 3 days. The days of recording will be randomly assigned so that all days of the week, including weekend days, will be equally represented. Instructions about recording type of foods and how to estimate the portion sizes in household measures will be given. On the scheduled visit, the trained personnel will check the dietary records for completeness, obtain additional information about unclear items or amounts, and use examples of household measures to improve the estimation. The daily nutrient intake will be calculated by the Food Processor Nutrition analysis and Fitness software version 8.0 (ESHA Research, Salem, USA), with addition of composition of local foods based on food composition table from China and Hong Kong. Change in diet quality in terms of energy intake would be measured as outcome.
Time Frame
12 weeks
Title
mid-arm circumference (MAC)
Description
change of MAC in cm
Time Frame
12 weeks
Title
calf circumference
Description
change of calf circumference in cm
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Kwok, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
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Oral Nutritional Supplement for the Patient With or at Risk of Malnutrition
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