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21 November 2008
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| [ Print-friendly version ] |
| A pilot trial of energy-dense supplements in malnourished patients |
| ISRCTN | ISRCTN96923961 |
| ClinicalTrials.gov identifier | |
| Public title | A pilot trial of energy-dense supplements in malnourished patients |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | NCC100 |
| 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 |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Malnutrition in the elderly |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 04/06/2007 |
| Anticipated end date | 30/12/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 75 |
| Interventions |
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. |
| Primary outcome measure(s) | Nutrient intake, assessed by diet diary at weeks one, two and four. |
| 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 |
| Sources of funding | Nutricia Clinical Care (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr Lucio Fumi |
| Address |
Nutricia Clinical Care
Whitehorse Business Park Trowbridge |
| City/town | Wiltshire |
| Zip/Postcode | BA14 0XQ |
| Country | United Kingdom |
| Sponsor | Nutricia Clinical Care (UK) |
| Address |
White Horse Business Park
Trowbridge |
| City/town | Wiltshire |
| Zip/Postcode | BA14 0XQ |
| Country | United Kingdom |
| Sponsor website: | http://www.nutricia-clinical-care.co.uk/asp/show_subject.asp |
| Date applied | 30/05/2007 |
| Last edited | 22/06/2007 |
| Date ISRCTN assigned | 22/06/2007 |
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