Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/05/2007
Date assigned
22/06/2007
Last edited
22/10/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lucio Fumi

ORCID ID

Contact details

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

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): 390–391

Publication citations

Additional files

Editorial Notes