A Randomised Trial of Oral Nutritional Supplements Versus Dietary Advice on Clinical Nutrition in the Community.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Southampton
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- The primary outcome measure is Quality of Life
Study Overview
Brief Summary
The purpose of this study is to determine the best form of dietary intervention to undernourished elderly individuals in care homes.
The research aims to test the null hypothesis that there is no difference between oral nutritional supplements and dietary advice as the first line treatment for malnutrition.
Detailed Description
A prospective, randomised, parallel, open-label trial, study in malnourished care home residents, without obvious dementia, to compare the effects of two common forms of nutritional support; dietary advice (DA) and oral nutritional supplements (ONS), on quality of life (QoL) and other outcomes including weight, nutritional intake and appetite. The residents were randomised to receive either DA provided by a dietitian or ONS for a period of 12 weeks. The primary outcome measure was QoL and the secondary outcome measure was dietary intake.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female
- •Age > 50 years
- •At risk of malnutrition
- •Competent to provide written informed consent and to answer questions
- •Able to eat and drink
- •Willingness to take part in the trial and to follow the trial protocol
Exclusion Criteria
- •Requirement for tube or parenteral nutrition
- •Galactosemia
- •Receiving current oral nutritional supplementation
- •Palliative care
- •Chronic renal disease requiring dialysis
- •Liver failure
- •Malignancy
- •Participation in other studies
Arms & Interventions
Dietary Advice
Dietary Advice
Intervention: Dietary Advice (Behavioral)
Oral Nutritional Supplements
Oral Nutritional Supplements
Intervention: Oral Nutritional Supplements (Fortisip) (Dietary Supplement)
Outcomes
Primary Outcomes
The primary outcome measure is Quality of Life
Time Frame: 6 months
Secondary Outcomes
No secondary outcomes reported