MalnutritionNCT04474886
Oral Nutritional Supplement for the Patient With or at Risk of Malnutrition
A study testing Fresubin® powder fibre in people with Malnutrition, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- Fresubin® powder fibre
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Nov 2020to 24 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intervention With Oral Nutritional Supplement (ONS) for the Patient With or at Risk of Malnutrition
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.
- Conditions
- Malnutrition
- Being tested
- Fresubin® powder fibre
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresubin® powder fibreDietary supplement
2 servings per day
| Study group | Role | What they receive |
|---|---|---|
| Fresubin® powder fibre | Experimental | 2 servings of Fresubin® powder fibre per day as supplement to normal diet Receives: Dietary Supplement: Fresubin® powder fibre |
| Usual diet | No intervention | Maintain usual diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
body weight
Change in body weight
Measured: 12 weeks
Secondary outcomes (8)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
mid-arm circumference (MAC)
change of MAC in cm
Measured: 12 weeks
calf circumference
change of calf circumference in cm
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start15 Nov 2020
- Primary completion24 Feb 2022
- Study completion24 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius Kabi
- Responsible party
- Principal investigator, Timothy Kwok, Chinese University of Hong Kong
- Investigators
- Timothy Kwok, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474886
- Sponsor's protocol ID
- 2020.223
- Status last verified
- Oct 2022
- First submitted
- 9 Jul 2020
- Last updated
- 7 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention With Oral Nutritional Supplement (ONS) for the Patient With or at Risk of Malnutrition
- ClinicalTrials.gov ID
- NCT04474886
- Acronym / sponsor ID
- 2020.223
- Conditions
- Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Fresenius Kabi
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 24 Feb 2022 (actual)
- Study completion
- 24 Feb 2022 (actual)
- First posted
- 17 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fresubin® powder fibre | Experimental | Dietary Supplement: Fresubin® powder fibre2 servings of Fresubin® powder fibre per day as supplement to normal diet |
| Usual diet | No intervention | –Maintain usual diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fresubin® powder fibre2 servings per day | Dietary supplement | Fresubin® powder fibre |
Primary outcome
body weight
Time frame: 12 weeks
Change in body weight
8 secondary outcomes
Body Mass Index
Time frame: 12 weeks
Mini Nutritional Assessment-short form(MNA-SF)
Time frame: 12 weeks
SF-12 Health Survey
Time frame: 12 weeks
Self-rated health
Time frame: 12 weeks
5-item FRAIL scale
Time frame: 12 weeks
3-day dietary record
Time frame: 12 weeks
mid-arm circumference (MAC)
Time frame: 12 weeks
calf circumference
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Malnutrition
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Active, not recruitingPhase 2
Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
Environmental Enteric Dysfunction (EED), Stunting
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Kwok, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fresubin® powder fibre in people with Malnutrition, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body weight (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022.