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Completed

NCT Number: NCT02730910

Anthocyanin & Phenolic Acids Bioavailability & Antioxidant Capacity After Consumption of Purple Wheat Products in Adults

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Nutraceutical Research Unit, University of Guelph

Guelph, Ontario, N1G2W1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Purple Wheat Crackers

Other

Whole grain crackers manufactured with purple wheat

Purple Wheat Granola Bars

Other

Whole grain granola bars manufactured with purple wheat

Primary outcomes

  1. Plasma concentrations of anthocyanin metabolites

    Time frame: 0-8 hours (0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8)

Secondary outcomes

  1. Plasma concentrations of phenolic acids

    Time frame: 0-8 hours (0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8)

  2. Plasma antioxidant capacity

    Time frame: 0-8 hours (0, 2, 4, 6, 8)

  3. Urinary concentrations of phenolic acids

    Time frame: 0-8 hours (0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8)

  4. Urinary concentrations of anthocyanin metabolites

    Time frame: 0-8 hours (0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8)

Sponsors and collaborators

Lead sponsor

University of Guelph

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Apr 7, 2016
Registry last updated
Apr 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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