- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02730910
Anthocyanin & Phenolic Acids Bioavailability & Antioxidant Capacity After Consumption of Purple Wheat Products in Adults
March 29, 2018 updated by: Amanda Wright, Ph.D., University of Guelph
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Guelph, Ontario, Canada, N1G2W1
- Human Nutraceutical Research Unit, University of Guelph
-
-
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 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- Smokers or use of recreational drugs (marijuana, magic mushrooms, etc)
- Elite or training athletes
- Following a vegan or vegetarian diet
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: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Purple Wheat Crackers
Bran-enriched purple wheat wholegrain crackers served in 120 g portion.
|
Whole grain crackers manufactured with purple wheat
|
|
Experimental: Purple Wheat Granola Bars
Bran-enriched purple wheat wholegrain granola bars served in 160 g portion.
|
Whole grain granola bars manufactured with purple wheat
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Plasma concentrations of anthocyanin metabolites
Time Frame: 0-8 hours (0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8)
|
0-8 hours (0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Plasma concentrations of phenolic acids
Time Frame: 0-8 hours (0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8)
|
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)
|
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)
|
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)
|
0-8 hours (0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
October 1, 2015
Primary Completion (Actual)
April 1, 2016
Study Completion (Actual)
March 1, 2017
Study Registration Dates
First Submitted
January 21, 2016
First Submitted That Met QC Criteria
April 1, 2016
First Posted (Estimate)
April 7, 2016
Study Record Updates
Last Update Posted (Actual)
April 2, 2018
Last Update Submitted That Met QC Criteria
March 29, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UGuelph
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Through peer reviewed publications
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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