CompletedNot Applicable

Oral Nutritional Supplement for the Patient With or at Risk of Malnutrition

Hong Kong88 participantsStarted 2020-11-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

body weight

Timeframe: 12 weeks

Trial details

NCT IDNCT04474886

SponsorChinese University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-02-24

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