Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NCC100
Study information
Scientific title
Acronym
Study hypothesis
Investigate the role of energy-dense supplements in the management of patients with malnutrition.
Ethics approval
Approval received from the Bath Local Research Ethics Committee on the 22nd March 2007 (ref: 07/Q2001/46).
Study design
Prospective, interventional, randomised, parallel, three-arm study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Malnutrition in the elderly
Intervention
The interventions are:
1. Standard dietary care
2. A high-energy supplement
3. A high energy supplement plus micronutrients
Duration: four weeks
Dosage: 400 kcal/day
Follow-up: patients are taking part in the trial for four weeks only. There is no further follow up.
Intervention type
Supplement
Phase
Not Specified
Drug names
Energy-dense supplementation
Primary outcome measures
Nutrient intake, assessed by diet diary at weeks one, two and four.
Secondary outcome measures
1. Gastro-Intestinal (GI) tolerance, using Bristol Stool Chart at weeks one, two and four
2. Product compliance, by daily questionnaire throughout the four weeks and product acceptability by questionnaire in weeks two and four
3. Appetite, measured in weeks one and four by questionnaire
4. Anthropometry (weight and Body Mass Index [BMI]), measured in weeks one, two and four
5. Muscle function, measured by hand grip dynamometry in weeks one and four
6. Quality of Life, measured using EuroQol EQ-5D questionnaire in weeks one and four
7. Blood lipids and micronutrients, measured in in weeks one and four
8. Safety, falls assessment measured using Berg Balance Scale at weeks one and four
Overall trial start date
04/06/2007
Overall trial end date
30/12/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
75
Participant 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
Recruitment start date
04/06/2007
Recruitment end date
30/12/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Nutricia Clinical Care
Wiltshire
BA14 0XQ
United Kingdom
Sponsor information
Organisation
Nutricia Clinical Care (UK)
Sponsor details
White Horse Business Park
Trowbridge
Wiltshire
BA14 0XQ
United Kingdom
Sponsor type
Industry
Website
http://www.nutricia-clinical-care.co.uk/asp/show_subject.asp
Funders
Funder type
Government
Funder name
Nutricia Clinical Care (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2008 results in: G.P. Hubbard, et al. A randomised, controlled trial of the effects of an energy-dense supplement on energy intake, appetite and blood lipids in malnourished community-based elderly patients. Journal of Human Nutrition and Dietetics. 2008; 21(4): 390391