Assessing the intake of nutritional beverages in older adults living in residential care facilities.

Category Primary study
Registry of TrialsANZCTR
Year 2022
INTERVENTION: 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 nutritio CONDITION: Diet and Nutrition ‐ Other diet and nutrition disorders Malnourished;At risk of malnutrition; ; Malnourished ; At risk of malnutrition PRIMARY OUTCOME: Compliance to nutritional beverage as assessed by weighing the amount of the beverage pre‐ and post‐consumption, using a set of digital scales, and calculating the difference. This will be done by the researcher. The participants will be given up to two hours to consume their beverage.[Twice daily for seven days after the start of the intervention] SECONDARY OUTCOME: Palatability ‐ assessed through a standardised questionnaire designed and used previously by the sponsor.[Bi‐weekly throughout the intervention period] Satiety ‐ assessed through a standardised questionnaire designed and used previously by the sponsor.[Bi‐weekly throughout intervention period] Tolerance ‐ documentation of gastric‐related adverse events via a tick bo Xquestionnaire filled out by the nursing/care staff,. ; [Daily throughout the intervention period] 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
Epistemonikos ID: b331112033a1dc1e5606007d9fb9d37dec7b251f
First added on: Aug 25, 2024