A pilot trial of energy-dense supplements in malnourished patients

ISRCTN	ISRCTN96923961
DOI	https://doi.org/10.1186/ISRCTN96923961
Protocol serial number	NCC100
Sponsor	Nutricia Clinical Care (UK)
Funder	Nutricia Clinical Care (UK)

Submission date: 30/05/2007
Registration date: 22/06/2007
Last edited: 22/10/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Lucio Fumi
Scientific

Nutricia Clinical Care
Whitehorse Business Park
Trowbridge
Wiltshire
BA14 0XQ
United Kingdom

Study information

Primary study design	Interventional
Study design	Prospective, interventional, randomised, parallel, three-arm study
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Investigate the role of energy-dense supplements in the management of patients with malnutrition.
Ethics approval(s)	Approval received from the Bath Local Research Ethics Committee on the 22nd March 2007 (ref: 07/Q2001/46).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Nutrient intake, assessed by diet diary at weeks one, two and four.
Key secondary outcome measure(s)	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
Completion date	30/12/2007

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	75
Key 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
Key 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
Date of first enrolment	04/06/2007
Date of final enrolment	30/12/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Nutricia Clinical Care

Wiltshire
BA14 0XQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		15/07/2008		Yes	No