Food PreferencesEarly Phase 1NCT01552252
Evaluation of an Apple Juice Drink With POs-Ca
A Early Phase 1 study testing apple juice, apple juice with 0.5% POs-Ca and apple juice with 1% POs-Ca in people with Food Preferences, run by Hitomi Mita.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Preferences
- What is being tested?
- apple juice, apple juice with 0.5% POs-Ca and apple juice with 1% POs-Ca
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Mar 2012
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- apple hypersensibility
About this study
Official title: 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.
- Conditions
- Food Preferences
- Being tested
- apple juice, apple juice with 0.5% POs-Ca, apple juice with 1% POs-Ca, apple juice with 1.5% POs-Ca, apple juice with 2% POs-Ca
- Keywords
- POs-Ca, calcium additives, drink
- Medical subject headings
- Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apple juiceDietary supplement
unaltered(0% POs-Ca) commercially available apple juice
apple juice with 0.5% POs-CaDietary supplement
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-CaDietary supplement
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-CaDietary supplement
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-CaDietary supplement
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
| Study group | Role | What they receive |
|---|---|---|
| 0% POs-Ca | Placebo comparator | Not described Receives: Dietary Supplement: apple juice |
| 0.5% POs-Ca | Active comparator | Not described Receives: Dietary Supplement: apple juice with 0.5% POs-Ca |
| 1% POs-Ca | Active comparator | Not described Receives: Dietary Supplement: apple juice with 1% POs-Ca |
| 1.5% POs-Ca | Active comparator | Not described Receives: Dietary Supplement: apple juice with 1.5% POs-Ca |
| 2% POs-Ca | Active comparator | Not described Receives: Dietary Supplement: apple juice with 2% POs-Ca |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At time when the subjects have finished drinking, an expected average of 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startMar 2010
- Primary completionMar 2010
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food PreferencesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hitomi Mita
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hitomi Mita, Tokyo Medical and Dental University
- Investigators
- Hitomi Mita, Principal investigator, Tokyo Medical and Dental University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01552252
- Sponsor's protocol ID
- POs-Ca02
- Status last verified
- Mar 2012
- First submitted
- 7 Mar 2012
- Last updated
- 13 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Low Erosive Apple Juice Drink With Phosphoryl Oligosaccharides of Calcium (POs-Ca)
- ClinicalTrials.gov ID
- NCT01552252
- Acronym / sponsor ID
- POs-Ca02
- Conditions
- Food Preferences
- Keywords
- POs-Ca, calcium additives, drink
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hitomi MitaUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 13 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 0% POs-Ca | Placebo comparator | Dietary Supplement: apple juice |
| 0.5% POs-Ca | Active comparator | Dietary Supplement: apple juice with 0.5% POs-Ca |
| 1% POs-Ca | Active comparator | Dietary Supplement: apple juice with 1% POs-Ca |
| 1.5% POs-Ca | Active comparator | Dietary Supplement: apple juice with 1.5% POs-Ca |
| 2% POs-Ca | Active comparator | Dietary Supplement: apple juice with 2% POs-Ca |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- apple hypersensibility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| apple juiceunaltered(0% POs-Ca) commercially available apple juice | Dietary supplement | 0% POs-Ca |
| apple juice with 0.5% POs-CaPhosphoryl 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 | Dietary supplement | 0.5% POs-Ca |
| apple juice with 1% POs-CaPhosphoryl Oligosaccharides of Calcium (POs-Ca) in the form of powder was added at concentrations of 1% by weight to a commercially available apple juice | Dietary supplement | 1% POs-Ca |
| apple juice with 1.5% POs-CaPhosphoryl 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 | Dietary supplement | 1.5% POs-Ca |
| apple juice with 2% POs-CaPhosphoryl Oligosaccharides of Calcium (POs-Ca) in the form of powder was added at concentrations of 2% by weight to a commercially available apple juice | Dietary supplement | 2% POs-Ca |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hitomi Mita principal investigator
Tokyo Medical and Dental University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing apple juice, apple juice with 0.5% POs-Ca and apple juice with 1% POs-Ca in people with Food Preferences, run by Hitomi Mita.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale of taste palatability (time frame: At time when the subjects have finished drinking, an expected average of 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2012.