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:

MedlinePlus related topics: Calcium

Drug Information available for: Calcium Gluconate Apple juice

U.S. FDA Resources

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

Criteria

Inclusion Criteria:

Exclusion Criteria:

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 May 22, 2013