Taste evaluation of oral nutritional supplements in Crohn's Disease
Research type
Research Study
Full title
An Investigation of palatability and Taste Preference of oral nutritional supplement drinks in Crohn's Disease adults and attitudes towards their long term use
IRAS ID
219562
Contact name
Nathan Davies
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2017/04/37, 20170412
Duration of Study in the UK
0 years, 2 months, 31 days
Research summary
Purpose of Study
To evaluate the relative palatability and patient preference from a range of commonly prescribed ONS dietary supplements. This study will inform future investigations examining the efficacy of ONS products in long term CD patient support.Background
ONS drinks are high in energy and are formulated in powder or liquid form, containing both macro and micronutrients. They can be used to either supplement normal eating or as a sole source of nutrition. Palatability of ONS is known to influence long-term compliance (Bolton et al 1992). Research (predominantly from Japan) has shown that replacement of 35-50% of habitual food intake with ONS drinks for up to 2 years can be as effective as certain medications in maintaining disease remission in adult CD.Relevance and importance to patients and the public
CD medications are known to have potentially serious side effects. To evaluate whether ONS drinks can be used as maintenance therapy in CD it is first essential to explore their acceptability and palatability.Eligibility
Patients with a confirmed histological diagnosis of CD in clinical remission aged 16-80 years of age with no other
major medical condition.Site
Patients with CD attending their outpatient appointments at University College London hospital (UCLH) adolescent and adult gastroenterology outpatient clinics. A private clinic room will be booked and a tasting station set up to complete the study.How long will the study last and what will the participants undergo?
A research student from University College London (UCL) and a clinical Dietitian based at UCLH will be conducting this research over a 12-week time frame.
There will be two parts to the study.
Part one will last approximately 1 hour. Patients will be required to test five different commercially available ONS
drinks. After each test a questionnaire will be completed to report on several taste characteristics and overall
impression using a hedonic rating scale.
At the end of the tasting session a further self-completion questionnaire will be given to evaluate patient attitudes
towards long term consumption of the preferred ONS drink. (see appendix 2 )
Part two: Patients will be offered the option of trialling the preferred ONS drink by taking home a supply of 7 bottles and asked to consume one full bottle per day for 1 week. At the end of the week the patient will be asked to complete a questionnaire related to attitudes, acceptability and tolerance of the ONS drink over an extended test period (see appendix 2), which will take approximately 20 minutes to complete.REC name
London - Brent Research Ethics Committee
REC reference
17/LO/1026
Date of REC Opinion
5 Jul 2017
REC opinion
Further Information Favourable Opinion