Evaluation of an Apple Juice Drink With POs-Ca

Food Preferences Clinical Trial

Official title:

Development and Evaluation of a Low Erosive Apple Juice Drink With Phosphoryl Oligosaccharides of Calcium (POs-Ca)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01552252
• Other study ID #: POs-Ca02
• Status: Completed
• Phase: Phase 0
• First received: March 7, 2012
• Last updated: March 8, 2012
• Start date: March 2010
• Est. completion date: March 2012

Study information

• Verified date: March 2012
• Source: Tokyo Medical and Dental University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2012
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• apple hypersensibility

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Food Preferences

Intervention

Dietary Supplement:
• apple juice
unaltered(0% POs-Ca) commercially available apple juice
• apple juice with 0.5% POs-Ca
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
• apple juice with 1% POs-Ca
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
• apple juice with 1.5% POs-Ca
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
• apple juice with 2% POs-Ca
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hitomi Mita

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No