Fortified Foods in Older Inpatients

NCT ID: NCT03176030

Last Updated: 2018-09-07

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2018-03-31

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.

Conditions

Malnutrition; Dementia; Aging; Frail Elderly Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Fortified foods

Fortified foods will be delivered to this group for 3 consecutive days mainly on a mid-meal trolley three times a day (between breakfast and lunch around 10am, between lunch and dinner around 3 pm, and in the evening). However, fortified foods will be available 24 hours and patients will be encouraged to order as many as they like anytime during the day.

Fortified Foods

Intervention Type: DIETARY_SUPPLEMENT

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.

Baseline

Prior to implementing the intervention, dietary intake among eligible patients offered the standard hospital menu will be measured on the study wards for 24 hours during three days in each of the study wards to estimate the energy and protein intake.

No interventions assigned to this group

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 70 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role: collaborator

University Hospital Southampton NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Southampton Genral Hospital

Southampton, , United Kingdom

Countries

United Kingdom

Other Identifiers

RHM MED1428

Identifier Type: -

Identifier Source: org_study_id