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

NCT02730910 | Completed

• 1 other identifier: UGuelph
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Bioavailability; adults

Outcome Measures

Primary Outcomes (1)

• Plasma concentrations of anthocyanin metabolites

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

Secondary Outcomes (4)

• Plasma concentrations of phenolic acids

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

• Plasma antioxidant capacity

  0-8 hours (0, 2, 4, 6, 8)

• Urinary concentrations of phenolic acids

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

• Urinary concentrations of anthocyanin metabolites

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

Study Arms (2)

Purple Wheat Crackers

EXPERIMENTAL

Bran-enriched purple wheat wholegrain crackers served in 120 g portion.

Other: Purple Wheat Crackers

Purple Wheat Granola Bars

EXPERIMENTAL

Bran-enriched purple wheat wholegrain granola bars served in 160 g portion.

Other: Purple Wheat Granola Bars

Interventions

Purple Wheat Crackers OTHER

Whole grain crackers manufactured with purple wheat

Purple Wheat Crackers

Purple Wheat Granola Bars OTHER

Whole grain granola bars manufactured with purple wheat

Purple Wheat Granola Bars

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Guelph: lead

Study Sites (1)

Human Nutraceutical Research Unit, University of Guelph

Guelph, Ontario, N1G2W1, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 21, 2016
• First Posted: April 7, 2016
• Study Start: October 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: March 1, 2017
• Last Updated: April 2, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)