Acceptability and Tolerance of New Oral Nutritional Supplement
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|ClinicalTrials.gov Identifier: NCT02639156|
Recruitment Status : Completed
First Posted : December 24, 2015
Last Update Posted : December 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Malnutrition||Dietary Supplement: AYMES LONDON||Not Applicable|
TITLE EVALUATION OF TOLERANCE AND ACCEPTABILITY OF AYMES LONDON STUDY OBJECTIVES
- To evaluate tolerance and acceptability of AYMES LONDON in patients requiring supplementary oral nutritional support compared with currently available alternatives.
- To obtain data to support an ACBS submissions for AYMES LONDON (to allow for prescription in the community at NHS expense).
STUDY DESIGN Interventional study. STUDY POPULATION 20 patients established on an oral nutritional supplement (ONS), requiring nutritional supplementation of at least 300kcal/day. Patients residing in community settings (e.g. own home, care home or community hospital) STUDY PRODUCTS AYMES LONDON Patients' current oral nutritional supplements STUDY GROUPS This is an observational study where the patient will act as their own control, there will be just one study group containing all patients STUDY OUTLINE Baseline: After recruitment patients will remain on their current oral nutritional supplement for 3 days, during which time baseline tolerance data will be recorded (number and consistency of bowel movements, daily, volume of ONS taken, any episodes of nausea, vomiting, burping, abdominal pain, bloating or diarrhoea). A three-day food diary will be kept to record total oral intake. Patients will also have anthropometric measurements carried out during this period (weight, height, body mass index (BMI)).
Intervention Period : Patients will then be changed onto an equivalent prescription of AYMES LONDON for a period of 9 days. Tolerance data will be recorded daily but the first 2 days on AYMES LONDON will be considered a 'transitional' period and data from these days will not be analysed. A further 3-day food diary will be kept during the intervention period. Weight of the patient will be recorded at the end of the period on AYMES LONDON, and an acceptability questionnaire will be completed.
Comparisons will be made between baseline and the end of each phase of the study using appropriate analysis methods.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Tolerance and Acceptability of AYMES 'LONDON' Product|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Patients established on an oral nutritional supplement, being prescribed 1-2 ONS providing at least 300kcal/day will be changed onto an equivalent prescription of AYMES LONDON for a period of 9 days.
Dietary Supplement: AYMES LONDON
AYMES LONDON is a powder, designed to be mixed with 75ml whole milk to make a dessert style ONS. When made-up, AYMES LONDON provides 303kcal (2.2kcal/ml) and 11.2g protein. It is not designed to be used as a sole source of nutrition. It is a Food for Special Medical Purposes (FSMP) and must therefore be used under medical supervision.
- GI Side Effects when using AYMES LONDON [ Time Frame: 9 days ]Recording of any nausea, vomiting, abdominal pain, bloating / flatulence when using AYMES LONDON as assessed by presence / absence of side effect compared to baseline period
- Change to bodyweight of subjects when using AYMES LONDON [ Time Frame: 9 DAYS ]Recording of body weight (kg) at start of study, start of intervention and end of intervention for comparison to investigate any significant weight change during the intervention period when compared to baseline.
- Compliance with prescription of AYMES LONDON [ Time Frame: 9 days ]Recording of amount of AYMES LONDON consumed by subjects to be compared to amount prescribed of intervention period compared to baseline period.
- Bowel habits of subjects when using AYMES LONDON [ Time Frame: 9 days ]Recording of bowel habits for one week using AYMES LONDON (as assessed by frequency and consistency of bowel movements (assessed by Bristol Stool Scale for consistency, and frequency of bowels open) compared to baseline period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639156
|Principal Investigator:||Alison Clark, BSc (Hons)||Alison Clark Health and Nutrition|