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

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.

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

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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