None listed
Conditions
Brief summary
The study aims to determine whether a proprietary nutritional supplement has a higher intake and is better tolerated than a standard supplement in elderly residential care residents suffering from malnutrition or at risk of malnutrition. Study hypothesis The preparatory nutrition supplements will have higher compliance rates when consumed by older adults who are malnourished or at risk of malnutrition living in residential care, compared to a standard supplement.
Interventions
WHY
Background and aims
This study aims to assess the compliance to novel nutritional supplements in older adults living in residential care with malnutrition or at risk of malnutrition. It aims to determine if the supplements have a higher level of compliance when compared to the standard product.
Participants
Adults over the age of 65 living in residential care who are at risk of malnutrition or who are malnourished.
WHAT
Participants identified as requiring a nutritional supplement will be
WHY Background and aims This study aims to assess the compliance to novel nutritional supplements in older adults living in residential care with malnutrition or at risk of malnutrition. It aims to determine if the supplements have a higher level of compliance when compared to the standard product. Participants Adults over the age of 65 living in residential care who are at risk of malnutrition or who are malnourished. WHAT Participants identified as requiring a nutritional supplement will be given either the standard supplement (control group) or a new preparatory supplement which has been formulated to increase palatability and gastric comfort (intervention group). WHO PROVIDED The intervention will be conducted by the residential home staff and will be overseen by clinical researchers. HOW & WHERE Participants will be recruited from residential care homes where the intervention will take place. The residential care home staff will collect data whilst the participants are undergoing the intervention, under the guidance of the clinical researchers. WHEN & HOW MUCH Participants will be given two serves per day for seven days. The supplements (either the proprietary supplements or standard supplement) will be taken orally. The supplements will be supplied to the participants for the duration of the intervention. Compliance will be assessed after each supplementation occasion through measuring the amount of the supplement consumed. Dietary information will be recorded and some health-related data will be collected. The participants will be provided with the comparator or proprietary beverage for seven days, and will cross-over at the end of the seven day period. As the study group require these nutritional supplements, there will be no washout period.
Sponsors
Fonterra Research and Development Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
>65 year Male and female Identified as malnourished or at risk of malnutrition Prescribed nutritional supplements Able to provide informed consent Living in a residential care facility
Exclusion criteria
<65 years Cannot provide informed consent Renal status would contraindicate the consumption of the supplement Have a terminal illness requiring palliative care Have a dairy or soy allergy Require Halal or Kosher diets Require nasogastric or parental feeding Recent hospitalisation Are taking dietary supplements which could influence the outcome of the study Have a clinical condition that, in the investigator’s judgement, is contraindicated
Outcome results
None listed