HealthyNCT02730910
Anthocyanin & Phenolic Acids Bioavailability & Antioxidant Capacity After Consumption of Purple Wheat Products in Adults
A study testing Purple Wheat Crackers and Purple Wheat Granola Bars in people with Healthy, run by University of Guelph at 1 site in Canada.
Trial summary
This study will determine the bioavailability of anthocyanins and phenolic compounds from two purple wheat products, i.e. bran-enriched wholegrain purple wheat crackers and bran-enriched wholegrain purple wheat granola bars. Crackers are an example of a baked/ processed product. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Purple Wheat Crackers and Purple Wheat Granola Bars
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2015to 1 Mar 2017
- Phase
- Interventional
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI of 18 - 27 kg/m2
- Generally healthy as determined by screening questionnaire
- Non-smoking
- Non to moderate alcohol drinkers (Typical consumption less than 5 drinks per sitting and no more than 14 per week)
Who cannot join
- Pregnant or breast-feeding females
- History of any major disease or medical condition, including any disorder of the gastrointestinal system or food intolerances
- Taking any prescription medications (including hormonal contraceptives) or over the counter medications prescribed by a medical professional
- Taking any natural health products or dietary supplements, other than a multivitamin low in anthocyanins and phenolic acids
- Oral antibiotic use in the past 3 months
- Any food allergies, and any anaphylactic or life-threatening allergies - food or otherwise
Show all 9Show fewer
- Smokers or use of recreational drugs (marijuana, magic mushrooms, etc)
- Elite or training athletes
- Following a vegan or vegetarian diet
Trial locations and contacts
1 site in 1 country.
Canada1 site
Human Nutraceutical Research Unit, University of Guelph
Guelph, Ontario, N1G2W1
About this study
Official title: Bioavailability of Anthocyanins and Phenolic Acids and Changes in Blood Antioxidant Capacity After Consumption of Purple Wheat Anthocyanin-enriched Crackers and Granola Bars by Healthy Adult Participants
This study will determine the bioavailability of anthocyanins and phenolic compounds from two purple wheat products, i.e. bran-enriched wholegrain purple wheat crackers and bran-enriched wholegrain purple wheat granola bars. Crackers are an example of a baked/ processed product. The purple wheat granola bars are an example of a food product that requires much less intensive preparation and cooking, compared to the crackers. A comparison of bioavailability between these two products should provide insights about how different processes and food matrix influence anthocyanin bioavailability and metabolism.
Read the detailed description
This study will determine the bioavailability of anthocyanins and phenolic compounds from two purple wheat products, i.e. bran-enriched wholegrain purple wheat crackers and bran-enriched wholegrain purple wheat granola bars. Crackers are an example of a baked/ processed product. The purple wheat granola bars are an example of a food product that requires much less intensive preparation and cooking, compared to the crackers. A comparison of bioavailability between these two products should provide insights about how different processes and food matrix influence anthocyanin bioavailability and metabolism. The study is a crossover investigation with 8 men and 8 women who will adhere to a low anthocyanin and low phenolic diet for the duration and complete 2 postprandial study visits where, in random order, they will consume either the crackers or granola bars. Blood and urine will be collected at baseline and postprandially for the analysis of anthocyanins and their metabolites and phenolic acids and determination of antioxidant capacity.
- Conditions
- Healthy
- Being tested
- Purple Wheat Crackers, Purple Wheat Granola Bars
- Keywords
- Bioavailability, adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Purple Wheat CrackersOther
Whole grain crackers manufactured with purple wheat
Purple Wheat Granola BarsOther
Whole grain granola bars manufactured with purple wheat
| Study group | Role | What they receive |
|---|---|---|
| Purple Wheat Crackers | Experimental | Bran-enriched purple wheat wholegrain crackers served in 120 g portion. Receives: Other: Purple Wheat Crackers |
| Purple Wheat Granola Bars | Experimental | Bran-enriched purple wheat wholegrain granola bars served in 160 g portion. Receives: Other: Purple Wheat Granola Bars |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of anthocyanin metabolites
Measured: 0-8 hours (0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8)
Secondary outcomes (4)
Plasma concentrations of phenolic acids
Measured: 0-8 hours (0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8)
Plasma antioxidant capacity
Measured: 0-8 hours (0, 2, 4, 6, 8)
Urinary concentrations of phenolic acids
Measured: 0-8 hours (0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8)
Urinary concentrations of anthocyanin metabolites
Measured: 0-8 hours (0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study startOct 2015
- Primary completionApr 2016
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda Wright, Ph.D., University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730910
- Sponsor's protocol ID
- UGuelph
- Status last verified
- Mar 2018
- First submitted
- 21 Jan 2016
- Last updated
- 2 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Through peer reviewed publications
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Anthocyanins and Phenolic Acids and Changes in Blood Antioxidant Capacity After Consumption of Purple Wheat Anthocyanin-enriched Crackers and Granola Bars by Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT02730910
- Acronym / sponsor ID
- UGuelph
- Conditions
- Healthy
- Keywords
- Bioavailability, adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 7 Apr 2016 (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.
This study will determine the bioavailability of anthocyanins and phenolic compounds from two purple wheat products, i.e. bran-enriched wholegrain purple wheat crackers and bran-enriched wholegrain purple wheat granola bars. Crackers are an example of a baked/ processed product. The purple wheat granola bars are an example of a food product that requires much less intensive preparation and cooking, compared to the crackers. A comparison of bioavailability between these two products should provide insights about how different processes and food matrix influence anthocyanin bioavailability and metabolism.
Detailed description
This study will determine the bioavailability of anthocyanins and phenolic compounds from two purple wheat products, i.e. bran-enriched wholegrain purple wheat crackers and bran-enriched wholegrain purple wheat granola bars. Crackers are an example of a baked/ processed product. The purple wheat granola bars are an example of a food product that requires much less intensive preparation and cooking, compared to the crackers. A comparison of bioavailability between these two products should provide insights about how different processes and food matrix influence anthocyanin bioavailability and metabolism. The study is a crossover investigation with 8 men and 8 women who will adhere to a low anthocyanin and low phenolic diet for the duration and complete 2 postprandial study visits where, in random order, they will consume either the crackers or granola bars. Blood and urine will be collected at baseline and postprandially for the analysis of anthocyanins and their metabolites and phenolic acids and determination of antioxidant capacity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Purple Wheat Crackers | Experimental | Other: Purple Wheat CrackersBran-enriched purple wheat wholegrain crackers served in 120 g portion. |
| Purple Wheat Granola Bars | Experimental | Other: Purple Wheat Granola BarsBran-enriched purple wheat wholegrain granola bars served in 160 g portion. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI of 18 - 27 kg/m2
- Generally healthy as determined by screening questionnaire
- Non-smoking
- Non to moderate alcohol drinkers (Typical consumption less than 5 drinks per sitting and no more than 14 per week)
Key exclusion criteria (9 listed)
- Pregnant or breast-feeding females
- History of any major disease or medical condition, including any disorder of the gastrointestinal system or food intolerances
- Taking any prescription medications (including hormonal contraceptives) or over the counter medications prescribed by a medical professional
- Taking any natural health products or dietary supplements, other than a multivitamin low in anthocyanins and phenolic acids
- Oral antibiotic use in the past 3 months
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 |
|---|---|---|
| Purple Wheat CrackersWhole grain crackers manufactured with purple wheat | Other | Purple Wheat Crackers |
| Purple Wheat Granola BarsWhole grain granola bars manufactured with purple wheat | Other | Purple Wheat Granola Bars |
Primary outcome
Plasma concentrations of anthocyanin metabolites
Time frame: 0-8 hours (0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8)
4 secondary outcomes
Plasma concentrations of phenolic acids
Time frame: 0-8 hours (0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8)
Plasma antioxidant capacity
Time frame: 0-8 hours (0, 2, 4, 6, 8)
Urinary concentrations of phenolic acids
Time frame: 0-8 hours (0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8)
Urinary concentrations of anthocyanin metabolites
Time frame: 0-8 hours (0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8)
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 2 Apr 2018.
- Individual participant dataSharing planned: Yes. Through peer reviewed publications
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Purple Wheat Crackers and Purple Wheat Granola Bars in people with Healthy, run by University of Guelph 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 4 inclusion and 9 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 2 Apr 2018. 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. 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?
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?
Plasma concentrations of anthocyanin metabolites (time frame: 0-8 hours (0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8)). 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 2 Apr 2018.