Fortified Foods in Older Inpatients

NCT03176030 | Withdrawn

• 1 other identifier: RHM MED1428
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition; Dementia; Aging; Frail Elderly Syndrome

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Acceptability of fortified food

  within 4 weeks of completing the intervention

Study Arms (2)

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.

Dietary Supplement: Fortified Foods

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.

Interventions

Fortified Foods 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.

Fortified foods

Eligibility Criteria

• Age: 70 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Southampton Genral Hospital

Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Malnutrition; Dementia

Interventions

Food, Fortified

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: June 5, 2017
• Study Start: September 1, 2017
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: September 7, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)