A pilot trial of energy-dense supplements in malnourished patients

Completed

• Conditions: Nutritional, Metabolic, Endocrine; Malnutrition in the elderly; Malnutrition

• Registration Number: ISRCTN96923961
• Lead Sponsor: utricia Clinical Care (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-22
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. Male or female
2. Aged greater than 50 years
3. At risk of malnutrition
4. Competent to provide written informed consent and able to answer questions
5. No requirement for tube or parenteral feeding
6. Willingness to take part in the trial and to follow the trial protocol

Exclusion Criteria

1. Requirement for tube or parenteral nutrition
2. Patients receiving palliative care
3. Patients with chronic renal disease requiring dialysis
4. Patients with liver failure
5. Participation in other studies
6. Taking a supplement in the last four weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
utrient intake, assessed by diet diary at weeks one, two and four.

Secondary Outcome Measures

Name	Time	Method
1. Gastro-Intestinal (GI) tolerance, using Bristol Stool Chart at weeks one, two and four<br>2. Product compliance, by daily questionnaire throughout the four weeks and product acceptability by questionnaire in weeks two and four<br>3. Appetite, measured in weeks one and four by questionnaire<br>4. Anthropometry (weight and Body Mass Index [BMI]), measured in weeks one, two and four<br>5. Muscle function, measured by hand grip dynamometry in weeks one and four<br>6. Quality of Life, measured using EuroQol EQ-5D questionnaire in weeks one and four<br>7. Blood lipids and micronutrients, measured in in weeks one and four<br>8. Safety, falls assessment measured using Berg Balance Scale at weeks one and four