Evaluation of an Apple Juice Drink With POs-Ca

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hitomi Mita, Tokyo Medical and Dental University
ClinicalTrials.gov Identifier:
NCT01552252
First received: March 7, 2012
Last updated: March 8, 2012
Last verified: March 2012
  Purpose

The null hypothesis tested was that there are no differences in the taste palatability of the apple juices before and after adding POs-Ca.


Condition Intervention Phase
Food Preferences
Dietary Supplement: apple juice
Dietary Supplement: apple juice with 0.5% POs-Ca
Dietary Supplement: apple juice with 1% POs-Ca
Dietary Supplement: apple juice with 1.5% POs-Ca
Dietary Supplement: apple juice with 2% POs-Ca
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Development and Evaluation of a Low Erosive Apple Juice Drink With Phosphoryl Oligosaccharides of Calcium (POs-Ca)

Resource links provided by NLM:


Further study details as provided by Tokyo Medical and Dental University:

Primary Outcome Measures:
  • Visual Analogue Scale of taste palatability [ Time Frame: At time when the subjects have finished drinking, an expected average of 10 minutes ] [ Designated as safety issue: No ]

    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.



Enrollment: 30
Study Start Date: March 2010
Study Completion Date: March 2012
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 0% POs-Ca Dietary Supplement: apple juice
unaltered(0% POs-Ca) commercially available apple juice
Active Comparator: 0.5% POs-Ca Dietary Supplement: 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
Active Comparator: 1% POs-Ca Dietary Supplement: 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
Active Comparator: 1.5% POs-Ca Dietary Supplement: 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
Active Comparator: 2% POs-Ca Dietary Supplement: 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

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01552252

Sponsors and Collaborators
Hitomi Mita
Investigators
Principal Investigator: Hitomi Mita Tokyo Medical and Dental University
  More Information

No publications provided

Responsible Party: Hitomi Mita, Development and Evaluation of a Low Erosive Apple Juice Drink with Phosphoryl Oligosaccharides of Calcium., Tokyo Medical and Dental University
ClinicalTrials.gov Identifier: NCT01552252     History of Changes
Other Study ID Numbers: POs-Ca02
Study First Received: March 7, 2012
Last Updated: March 8, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Tokyo Medical and Dental University:
POs-Ca
calcium additives
drink

ClinicalTrials.gov processed this record on April 17, 2014