Evaluation of an Apple Juice Drink With POs-Ca
Development and Evaluation of a Low Erosive Apple Juice Drink With Phosphoryl Oligosaccharides of Calcium (POs-Ca)
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
The null hypothesis tested was that there are no differences in the taste palatability of the apple juices before and after adding POs-Ca.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Mar 2010
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 7, 2012
CompletedFirst Posted
Study publicly available on registry
March 13, 2012
CompletedMarch 13, 2012
March 1, 2012
Same day
March 7, 2012
March 8, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual Analogue Scale of taste palatability
Tasters were first asked to drink the unaltered (0% POs-Ca) juice, to get familiar with the taste. After that they drank each of the 5 juices in a random order, and evaluated the taste by marking an analogue scale ranging from 0 to 100 which was printed horizontally on a sheet of paper.
At time when the subjects have finished drinking, an expected average of 10 minutes
Study Arms (5)
0% POs-Ca
PLACEBO COMPARATOR0.5% POs-Ca
ACTIVE COMPARATOR1% POs-Ca
ACTIVE COMPARATOR1.5% POs-Ca
ACTIVE COMPARATOR2% POs-Ca
ACTIVE COMPARATORInterventions
Phosphoryl Oligosaccharides of Calcium (POs-Ca) in the form of powder was added at concentrations of 0.5% by weight to a commercially available apple juice
Phosphoryl Oligosaccharides of Calcium (POs-Ca) in the form of powder was added at concentrations of 1% by weight to a commercially available apple juice
Phosphoryl Oligosaccharides of Calcium (POs-Ca) in the form of powder was added at concentrations of 1.5% by weight to a commercially available apple juice
Phosphoryl Oligosaccharides of Calcium (POs-Ca) in the form of powder was added at concentrations of 2% by weight to a commercially available apple juice
Eligibility Criteria
You may qualify if:
- healthy adult subjects
- No eating or drinking within 30 minutes before the start time of the trials
- No tooth brushing within 30 minutes before the start time of the trials
You may not qualify if:
- apple hypersensibility
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hitomi Mitalead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hitomi Mita
Tokyo Medical and Dental University
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Development and Evaluation of a Low Erosive Apple Juice Drink with Phosphoryl Oligosaccharides of Calcium.
Study Record Dates
First Submitted
March 7, 2012
First Posted
March 13, 2012
Study Start
March 1, 2010
Primary Completion
March 1, 2010
Study Completion
March 1, 2012
Last Updated
March 13, 2012
Record last verified: 2012-03