A pilot trial of energy-dense supplements in malnourished patients
| ISRCTN | ISRCTN96923961 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96923961 |
| Secondary identifying numbers | NCC100 |
- 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
Scientific
Nutricia Clinical Care
Whitehorse Business Park
Trowbridge
Wiltshire
BA14 0XQ
United Kingdom
Study information
| Study design | Prospective, interventional, randomised, parallel, three-arm study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 04/06/2007 |
| Completion date | 30/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Nutricia Clinical Care
Wiltshire
BA14 0XQ
United Kingdom
BA14 0XQ
United Kingdom
Sponsor information
Nutricia Clinical Care (UK)
Industry
Industry
White Horse Business Park
Trowbridge
Wiltshire
BA14 0XQ
United Kingdom
| Website | http://www.nutricia-clinical-care.co.uk/asp/show_subject.asp |
|---|---|
"ROR" |
https://ror.org/007hfqg84 |
Funders
Funder type
Government
Nutricia Clinical Care (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
