Community Oral Nutrition Support Trial

U

University of Southampton

Status

Completed

Conditions

Malnutrition

Treatments

Dietary Supplement: Oral Nutritional Supplements (Fortisip)
Behavioral: Dietary Advice

Study type

Interventional

Funder types

Other

Identifiers

NCT00515125
ELIA0001

Details and patient eligibility

About

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.

Full 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.

Enrollment

104 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

104 participants in 2 patient groups

Dietary Advice
Other group
Description:
Dietary Advice
Treatment:
Behavioral: Dietary Advice
Oral Nutritional Supplements
Other group
Description:
Oral Nutritional Supplements
Treatment:
Dietary Supplement: Oral Nutritional Supplements (Fortisip)

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems