Clinical trial NCT03176030: Fortified Foods in Older Inpatients
Official title: Can Fortified Foods Improve Energy and Protein Intake in Older People Whilst in Hospital? A Pilot Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Malnutrition
Dementia
Aging
Frail Elderly Syndrome
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: NIHR Southampton Biomedical Research Centre
First posted: 2017-06-05
Enrollment: 0
Sex: ALL
Minimum age (years): 70
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients will be female and male older patients who are admitted to acute medical wards for older people in two hospitals.

Brief summary: Malnutrition in older inpatients is a significant problem espicially among those with dementia. A number of methods have been used to tackle this issue and oral nutritional supplements (ONS) were proven to be the most effective way. However, they are limited by their poor tolerability due to lack of familiarity with these products. An alternative method is to fortify familiar food with protein, energy and micronutrient. thus, the aim of this study to test the feasibility and acceptability of delivering fortified foods to older patients whilst in hospital including those with dementia and frailty. This pilot study will compare the daily protein and energy intake in older people before and after offering fortified food. Furthermore, patients' likeability and staff acceptability of these fortified foods will be assessed.

Detailed description: Malnutrition is a significant problem amongst hospitalised older people, and can impede effective recovery. Oral nutritional supplements (ONS) are limited by their poor tolerability and an alternative strategy is food fortification, the addition of protein/energy/micronutrients to frequently eaten food. The aim of this pilot study is to establish the feasibility and acceptability of delivering fortified foods to older people including those who have dementia and frailty whilst in hospital and to assess whether fortified foods could increase the energy and protein intake.

This is a quasi-experimental study on acute medical wards for older inpatient in two UK hospitals, with a before and after comparison. The intervention involves the provision of additional between-meal fortified foods (enhanced with protein, energy, and micronutrients) and meal supplementation. Daily energy and protein intake will be assessed for three consecutive days during the baseline period and then in the intervention period. Likeability of fortified food and food choices (the number, type, and frequency of fortified foods consumed) will be examined. Likeability of fortified food by patients will be assessed using likeability scales. Interviews or focus groups will be conducted with staff to assess the acceptability of fortified food. Costs related to developing, packing and delivering the fortified foods will be calculated.

The findings of this pilot study will identify whether delivering fortified food is feasible in acute elderly care wards, which foods are preferred and their acceptability. The results will inform the design of a definitive clinical trial.

Eligibility criteria: Inclusion Criteria:

1. Both female and male participants in each hospital.
2. Patients aged 70 years and above including those who have dementia and frailty.

Exclusion Criteria:

1. Patients receiving enteral tube feeding or parenteral nutrition
2. Patients with a known food allergy, eating disorder or illness, which requires a therapeutic diet incompatible with fortification.
3. Patients who are receiving end of life care.

Primary outcomes:
measure: Daily energy and protein intake
timeFrame: 3 consecutive months
measure: Feasibility of delivering fortified foods
timeFrame: 3 days intervention period
measure: Patient's likeability of fortified foods
timeFrame: 3 days intervention period
Secondary outcomes:
measure: Acceptability of fortified food
timeFrame: within 4 weeks of completing the intervention
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: Southampton Genral Hospital
Study officials:
References: