Community Oral Nutrition Support Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomised Trial of Oral Nutritional Supplements Versus Dietary Advice on Clinical Nutrition in the Community.

Conditions
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Malnutrition

Intervention / Treatment
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* Behavioral: Dietary Advice
* Dietary Supplement: Oral Nutritional Supplements (Fortisip)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Dietary Advice<br>Dietary Advice | Behavioral: Dietary Advice<br>* Dietary Advice sheet<br>|
| Other: Oral Nutritional Supplements<br>Oral Nutritional Supplements | Dietary Supplement: Oral Nutritional Supplements (Fortisip)<br>* These products are classified as non-medicinal, borderline substances, foods for special medical purposes. A range of commercially available liquid oral nutritional supplements (Fortisip) will be offered daily for a 12 week period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure is Quality of Life |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of life, Supplement, Care home, Elderly, Malnutrition