Fortified Foods in Older Inpatients

Aging Clinical Trial

Official title:

Can Fortified Foods Improve Energy and Protein Intake in Older People Whilst in Hospital? A Pilot Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03176030
• Other study ID #: RHM MED1428
• Status: Withdrawn
• Start date: September 1, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: September 2018
• Source: University Hospital Southampton NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Dementia
• Frail Elderly Syndrome
• Malnutrition

Intervention

Dietary Supplement:
• Fortified Foods
The intervention under study is the provision of between-meal fortified foods (enhanced with protein, energy, and micronutrients) and meal supplementation where meals are poorly consumed. Foods will include both savory and sweet foods with different flavors. Foods will be matched as closely as possible in protein and energy and are calculated to provide typically 210 kcal and 5g protein per item. The volume / weight of the foods are standardized to be of relatively small portion size, such as 100 ml for ice-creams, 40 g for cakes and biscuits, and 100 ml for soup. Some of the products will be supplemented with micronutrients particularly needed by older adults, such as Vitamins (C, D, folic acid, B2, B6) and calcium at one third of the Dietary Reference Values (DRV) per portion. The aim is to achieve a daily consumption of two additional fortified food items.

Locations

Country	Name	City	State
United Kingdom	Southampton Genral Hospital	Southampton

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Southampton NHS Foundation Trust	NIHR Southampton Biomedical Research Centre

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily energy and protein intake	Daily dietary intake will be assessed on three days during both the baseline and intervention periods using visual assessment. each food or meal will be weighed before serving and once the patient has finished using calibrated scales. In addition, a photograph of each plate of food will be taken before and after consumption for each eligible patient. At the end of each meal, the proportion of uneaten (leftover) food will be recorded in quartiles (0%, 25%, 50%, 75%, or 100%) for each component	3 consecutive months
Primary	Feasibility of delivering fortified foods	The number, type, and frequency of fortified foods chosen by eligible patients during the intervention period will be recorded. This will be done by using a food chart with images. Thus data will be collected on the type of foods (ice-creams, biscuits, soups or cakes) chosen, flavors preferred by individual patients initially and repeat choices, the number of foods chosen each time and at which time of the day.	3 days intervention period
Primary	Patient's likeability of fortified foods	A 9-point likeability scale will be completed for each eligible patient to test likeability of fortified foods after each meal or snack time during the intervention period.	3 days intervention period
Secondary	Acceptability of fortified food	A purposive sample staff (nursing staff, catering staff and volunteers) involved in the delivery of fortified foods from the study wards in both hospitals will be invited to take part in interviews or focus groups. Participants will be recruited until theoretical saturation has been met; a total sample of approximately 15-20 staff members across the two settings is anticipated to be adequate.	within 4 weeks of completing the intervention