- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02642783
Sensory Properties of Bowel Cleansing Solutions
December 29, 2015 updated by: Ammar Olabi, American University of Beirut Medical Center
Sensory Evaluation of Laxative Bowel Solutions Used Prior to Colonoscopy
Samples of 4 commercially available bowel cleansing solutions, namely PEG-electrolyte + ascorbic acid (PEG-Asc, Moviprep®, Norgine, UK), PEG-electrolyte (PEG, Fortrans® Ibsen, France), sodium picosulfate/magnesium citrate (SPS, Picoprep®, Ferring, Switzerland), and oral sodium sulfate (OSS, Izinova®, Ibsen, France) were prepared according to the manufacturer's instructions.
Descriptive analysis was conducted with trained panelists (N= 14) to create a sensory profile for the solutions and generated attributes were rated on an unstructured 15-cm line scale using the Compusense at-hand® (Guelph, Canada) sensory evaluation software.
Acceptability testing was carried out with untrained participants (N=80) and samples were rated on the 9-point hedonic scale.
Moreover, a Just-About-Right (JAR) scale was included for the four basic tastes to determine their compatibility with optimum taste/acceptability levels in the products.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age between 18 and 50 years
Exclusion Criteria:
- allergies to polyethelene glycol (PEG), artificial sweeteners
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Descriptive analysis
panelists were asked to rate different sensory attributes for different laxative bowel cleansing solutions on a 15 cm line scale.
|
subjects were asked to assess the sensory profile by tasting the laxative bowel cleansing solutions, namely: Moviprep, picoprep, fortrans and isinova
|
Other: Acceptability test
panelists were asked to rate the acceptability of different laxative bowel cleansing solutions using the 9-point hedonic scale.
|
subjects were asked to assess the acceptability of the laxative bowel cleansing solutions, namely: Moviprep, picoprep, fortrans and isinova
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
rating of sensory attributes
Time Frame: 3 weeks
|
participants attended 4 training sessions during which they generated sensory descriptive attributes specific for the tasted laxative solutions.
In addition, they evaluated the laxative samples by rating generated attributes on a 15-cm unstructured line scale using compusense at-hand sensory evaluation software.
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability Score
Time Frame: 1 week
|
untrained participants evaluated the laxative samples for acceptability testing using the 9-point hedonic scale.
|
1 week
|
Just about right score
Time Frame: 1 week
|
Participants evaluated the laxative samples for the 4 basic tastes (saltiness, sourness, sweetness and bitterness) to determine their compatibility with optimum taste levels in the products.
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2015
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
December 22, 2015
First Submitted That Met QC Criteria
December 29, 2015
First Posted (Estimate)
December 30, 2015
Study Record Updates
Last Update Posted (Estimate)
December 30, 2015
Last Update Submitted That Met QC Criteria
December 29, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- NUT.AO.19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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