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Evaluation of an Apple Juice Drink With POs-Ca

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01552252
First Posted: March 13, 2012
Last Update Posted: March 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hitomi Mita, Tokyo Medical and Dental University
  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 Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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 Hitomi Mita, 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 ]

    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01552252


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

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
First Submitted: March 7, 2012
First Posted: March 13, 2012
Last Update Posted: March 13, 2012
Last Verified: March 2012

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

Additional relevant MeSH terms:
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs


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