Pre-diabetesNCT02139878
Short-term Health Effects of Wild Blueberry Juice Consumption
A study testing Wild blueberry juice in people with Pre-diabetes, run by University of Prince Edward Island at 1 site in Canada.
Trial summary
Researchers at the University of Prince Edward Island want to learn about the health effects of wild blueberry juice. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-diabetes
- What is being tested?
- Wild blueberry juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- May 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy individuals at risk for type 2 diabetes
Who cannot join
- have a body mass index of less than 20 and greater than 45 kg/m2.
- are less than 21 and greater than 65 years old at beginning of study
- have smoked or used tobacco within 6 months prior to the start of the study
- are pregnant, plan to become pregnant or become pregnant during the study
- have a history or presence of kidney disease, liver disease, certain cancers, gastrointestinal, other metabolic diseases, or malabsorption syndromes
- have type 2 diabetes and need to use oral diabetic drugs or insulin
- have an allergy or adverse reaction to blueberries
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Prince Edward Island, Health Sciences
Charlottetown, Prince Edward Island, C1A 4P3
About this study
Researchers at the University of Prince Edward Island want to learn about the health effects of wild blueberry juice.
- Conditions
- Pre-diabetes
- Being tested
- Wild blueberry juice, Placebo wild blueberry juice
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wild blueberry juiceOther
Placebo wild blueberry juiceOther
| Study group | Role | What they receive |
|---|---|---|
| Wild blueberry juice | Experimental | 240 ml wild blueberry juice Receives: Other: Wild blueberry juice |
| Placebo wild blueberry juice | Placebo comparator | 240 ml placebo wild blueberry juice Receives: Other: Placebo wild blueberry juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Systolic blood pressure
Measured: Up to 4 weeks
Secondary outcomes (1)
Glucose
Plasma blood glucose concentrations
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre-diabetesStudies 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
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Prince Edward Island
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Stote, University of Prince Edward Island
- Investigators
- Katherine Gottschall-Pass, PhD, RD, Principal investigator, University of Prince Edward Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139878
- Sponsor's protocol ID
- UPEI HS 01
- Status last verified
- Dec 2016
- First submitted
- 4 May 2014
- Last updated
- 28 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Stote KS, Sweeney MI, Kean T, Baer DJ, Novotny JA, Shakerley NL, Chandrasekaran A, Carrico PM, Melendez JA, Gottschall-Pass KT. The effects of 100% wild blueberry (Vaccinium angustifolium) juice consumption on cardiometablic biomarkers: a randomized, placebo-controlled, crossover trial in adults with increased risk for type 2 diabetes. BMC Nutr. 2017 May 25;3:45. doi: 10.1186/s40795-017-0164-0. eCollection 2017.
PubMed 32153825
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Health Effects of Wild Blueberry Juice Consumption
- ClinicalTrials.gov ID
- NCT02139878
- Acronym / sponsor ID
- UPEI HS 01
- Conditions
- Pre-diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Prince Edward IslandUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 15 May 2014 (estimated)
- Results
- Posted 17 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers at the University of Prince Edward Island want to learn about the health effects of wild blueberry juice.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wild blueberry juice | Experimental | Other: Wild blueberry juice240 ml wild blueberry juice |
| Placebo wild blueberry juice | Placebo comparator | Other: Placebo wild blueberry juice240 ml placebo wild blueberry juice |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy individuals at risk for type 2 diabetes
Key exclusion criteria (7 listed)
- have a body mass index of less than 20 and greater than 45 kg/m2.
- are less than 21 and greater than 65 years old at beginning of study
- have smoked or used tobacco within 6 months prior to the start of the study
- are pregnant, plan to become pregnant or become pregnant during the study
- have a history or presence of kidney disease, liver disease, certain cancers, gastrointestinal, other metabolic diseases, or malabsorption syndromes
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 |
|---|---|---|
| Wild blueberry juice | Other | Wild blueberry juice |
| Placebo wild blueberry juice | Other | Placebo wild blueberry juice |
Primary outcome
Blood Pressure
Time frame: Up to 4 weeks
Systolic blood pressure
1 secondary outcome
Glucose
Time frame: Up to 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32153825Stote KS, Sweeney MI, Kean T, Baer DJ, Novotny JA, Shakerley NL, Chandrasekaran A, Carrico PM, Melendez JA, Gottschall-Pass KT. The effects of 100% wild blueberry (Vaccinium angustifolium) juice consumption on cardiometablic biomarkers: a randomized, placebo-controlled, crossover trial in adults with increased risk for type 2 diabetes. BMC Nutr. 2017 May 25;3:45. doi: 10.1186/s40795-017-0164-0. eCollection 2017.
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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.
Katherine Gottschall-Pass, PhD, RD principal investigator
University of Prince Edward Island
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wild blueberry juice in people with Pre-diabetes, run by University of Prince Edward Island at 1 site in Canada.
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 1 inclusion and 7 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 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Blood Pressure (time frame: Up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02139878, which also lists 1 linked publication.
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 28 Mar 2017.