Clinical trial NCT02730910: Anthocyanin & Phenolic Acids Bioavailability & Antioxidant Capacity After Consumption of Purple Wheat Products in Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Bioavailability
adults
Lead sponsor: University of Guelph
Sponsor class: OTHER
First posted: 2016-04-07
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasma concentrations of anthocyanin metabolites
timeFrame: 0-8 hours (0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8)
Secondary outcomes:
measure: Plasma concentrations of phenolic acids
timeFrame: 0-8 hours (0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8)
measure: Plasma antioxidant capacity
timeFrame: 0-8 hours (0, 2, 4, 6, 8)
measure: Urinary concentrations of phenolic acids
timeFrame: 0-8 hours (0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8)
measure: Urinary concentrations of anthocyanin metabolites
timeFrame: 0-8 hours (0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8)
Other outcomes:
Locations:
city: Guelph
country: Canada
facility: Human Nutraceutical Research Unit, University of Guelph
state: Ontario
Study officials:
References: