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A pilot trial of energy-dense supplements in malnourished patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN96923961
Enrollment
75
Registered
2007-06-22
Start date
2007-06-04
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition in the elderly Nutritional, Metabolic, Endocrine Malnutrition

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 p

Sponsors

Nutricia Clinical Care (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Nutrient intake, assessed by diet diary at weeks one, two and four.

Secondary

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026