None listed
Conditions
Brief summary
This randomised controlled trial will evaluate a 12-week intervention providing two eggs per day to older adults in retirement living (retirement villages, community living) , with outcomes assessed at baseline, week 6, week 12, and 6 months from the beginning of the intervention. The primary hypothesis is that participants in villages allocated to the increased egg intake intervention will have greater improvements in Mini Nutritional Assessment total scores at 12 weeks compared with control villages continuing usual intake (less than one egg per day). Key secondary hypotheses are that, at 12 weeks, intervention participants will have greater gains in physical function, assessed by the Short Physical Performance Battery and additional physical function tests (HGS, TUG, ADLs), than controls, and will report better health-related quality of life measured by the SF-36 Physical Component Summary. Additionally, it's hypothesised that all blood markers (total cholesterol, HDL, LDL, triglycerides and glucose) will have no significant difference between groups. The trial will also assess implementation outcomes, with the hypothesis that intervention participants will achieve high adherence, defined as consuming at least 80 percent of prescribed eggs over 12 weeks. A further hypothesis is that intervention participants will report high acceptability of incorporating eggs into their regular diet, including favourable ratings of taste, ease of preparation, frequency tolerance, and perceived health effects, and that trial data will identify practical strategies to support sustained egg consumption in this population.
Interventions
This randomised controlled trial will evaluate the effectiveness of a 12-week intervention (2 eggs/day) on nutritional status, physical function, and quality of life among older adults living in retirement villages, with outcomes assessed at baseline (T1), week 6 (T2), week 12 (T3), and 6-month follow up (T4). The study will also identify practical strategies to support egg consumption in this population.
Participants will be randomised to one of two treatment arms; intervention or control. In
This randomised controlled trial will evaluate the effectiveness of a 12-week intervention (2 eggs/day) on nutritional status, physical function, and quality of life among older adults living in retirement villages, with outcomes assessed at baseline (T1), week 6 (T2), week 12 (T3), and 6-month follow up (T4). The study will also identify practical strategies to support egg consumption in this population. Participants will be randomised to one of two treatment arms; intervention or control. Intervention includes increased egg intake to 2 eggs per day, deemed a single serving of protein according to the Australian Guide to Healthy Eating. Control will continue with diet as normal. The intervention group will be provided with raw eggs to cook with along with recipes to the sum 2 eggs per day (14 eggs per week). Adherence will be measured using self-reported dietary logs, returning of egg cartons and/or verbal confirmation of egg consumption during each delivery of eggs, as well as tracking of egg consumption through 3-day food records.
Sponsors
University of Melbourne
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Living in Victoria, Australia Retirement living (i.e. lives in retirement villages, community dwelling, etc) Aged 65 years or older Currently living with malnutrition (MNA <17), or at risk of malnutrition (MNA 17-23.5) with self-reported weight loss or low-protein intake (<0.8g/kg) confirmed via 3-day food diary Not intending to lose weight over the next 6 months Willingness to complete dietary records via a computer or smart-phone or paper-based food-diary records Understand and communicate in English Willing to make dietary and/or behavioural changes in line if allocated to the intervention group for 12-weeks Availability and willingness to attend all study visits and 6-month follow-up Ability to provide informed consent
Exclusion criteria
Diagnosed egg allergy (IgE-mediated or clinician-diagnosed), including prior anaphylaxis to egg. Any other documented severe adverse reactions to egg requiring medical treatment (even if not formally labelled “allergy”) Familial hypercholesterolaemia (FH) (genetic or clinician diagnosed). Moderate to severe chronic kidney disease (CKD) requiring dietary restriction of protein, phosphorus or potassium including dialysis-treated kidney disease, or clinician-diagnosed hyperphosphataemia. Any unstable or clinically significant cardiometabolic condition that, in the opinion of the study doctor or investigator, would make participation unsafe or confound interpretation of outcomes, including: - recent major myocardial infarction, stroke, coronary revascularisation, or hospitalisation for unstable heart failure within the past 6 months - unstable angina or decompensated heart failure - severe uncontrolled hypertension - uncontrolled diabetes requiring acute treatment changes - active medical advice to restrict egg intake or dietary cholesterol Current immunosuppressive therapy, active immunosuppression, or history of solid organ transplant. Unable to follow written and verbal instructions Terminal illness with less than 6 months to live Currently consuming greater than or equal to 6 eggs per week Current enteral/parenteral feeding preventing whole-food intake Immobile (eg chair or bed bound)
Outcome results
None listed