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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02730910
• Other study ID #: UGuelph
• Status: Completed
• Phase: N/A
• First received: January 21, 2016
• Last updated: March 29, 2018
• Start date: October 2015
• Est. completion date: March 1, 2017

Study information

• Verified date: March 2018
• Source: University of Guelph
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 1, 2017
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Purple Wheat Crackers
Whole grain crackers manufactured with purple wheat
• Purple Wheat Granola Bars
Whole grain granola bars manufactured with purple wheat

Locations

Country	Name	City	State
Canada	Human Nutraceutical Research Unit, University of Guelph	Guelph	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Guelph

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentrations of anthocyanin metabolites		0-8 hours (0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8)
Secondary	Plasma concentrations of phenolic acids		0-8 hours (0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8)
Secondary	Plasma antioxidant capacity		0-8 hours (0, 2, 4, 6, 8)
Secondary	Urinary concentrations of phenolic acids		0-8 hours (0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8)
Secondary	Urinary concentrations of anthocyanin metabolites		0-8 hours (0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8)