Evaluation of an Apple Juice Drink With POs-Ca

March 8, 2012 updated by: Hitomi Mita

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Early Phase 1

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 25 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At time when the subjects have finished drinking, an expected average of 10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hitomi Mita

Investigators

  • Principal Investigator: Hitomi Mita, Tokyo Medical and Dental University

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

March 1, 2010

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

March 7, 2012

First Submitted That Met QC Criteria

March 8, 2012

First Posted (Estimate)

March 13, 2012

Study Record Updates

Last Update Posted (Estimate)

March 13, 2012

Last Update Submitted That Met QC Criteria

March 8, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • POs-Ca02

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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