Effects of oral nutritional supplements compared to fortified foods on energy and protein intake in undernourished geriatric inpatients
| ISRCTN | ISRCTN04327195 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04327195 |
| Protocol serial number | N/A |
| Sponsor | Medical Centre Leeuwarden (Netherlands) |
| Funders | Nutricia Research Foundation, Danone Research Centre for Specialised Nutrition |
- Submission date
- 24/09/2012
- Registration date
- 03/10/2012
- Last edited
- 09/11/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
The aim of this study is to find out whether energy-dense small-volume oral nutritional supplements (ONS) are more effective than fortified food at helping hospitalized elderly people reach their recommended energy and protein intakes.
Who can participate?
Geriatric inpatients who are undernourished or at risk of undernutrition.
What does the study involve?
Participants are randomly allocated to either receive energy-dense small-volume oral nutritional supplements or fortified foods.
What are the possible benefits and risks of participating?
Possible benefits are increased nutritional intake resulting in improved nutritional, functional and clinical outcomes.
Where is the study run from?
Department of Geriatric Medicine, Medical centre Leeuwarden (Netherlands)
When is study starting and how long is it expected to run for?
November 2009 to May 2010
Who is funding the study?
Nutricia Netherlands BV and Danone Research, Centre for Specialised Nutrition (Netherlands)
Who is the main contact?
Dr DZB van Asselt
Contact information
Scientific
Department of Geriatric Medicine
Medical Centre Leeuwarden
Postbus 888
Leeuwarden
8901 BR
Netherlands
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Parallel two arms randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effects of oral nutritional supplements compared to fortified foods on energy and protein intake in undernourished geriatric inpatients: a randomised controlled trial |
| Study objectives | In between meals, energy dense, small volume oral nutritional supplements (ONS) are more effective than fortified food to reach recommended energy and protein intakes in hospitalized elderly. |
| Ethics approval(s) | Regional Assessment Patient Research (Regionale Toetsingscommissie Patiengebonden Onderzoek) (RTPO), 12/10/2009, ref: TPO 648 |
| Health condition(s) or problem(s) studied | Malnutrition |
| Intervention | Intervention group: Energy dense, small volume oral nutritional supplements Control group: fortified foods Duration of intervention: during hospitalisation until discharge. |
| Intervention type | Supplement |
| Primary outcome measure(s) |
Number of patients achieving an extra intake of 450 kcal per day |
| Key secondary outcome measure(s) |
1. Recommended energy and protein intakes |
| Completion date | 15/05/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 108 |
| Key inclusion criteria | Risk of malnutrition (MNA-sf score 8-11) or malnutrition (MNA-sf score <7) |
| Key exclusion criteria | 1. Terminal illness 2. Expected death during hospitalization / palliation 3. Hospital stay shorter than 14 days 4. Incomplete patient files 5. Need for tube feeding 6. A nothing per mouth order |
| Date of first enrolment | 01/11/2009 |
| Date of final enrolment | 15/05/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
8901 BR
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
