Overview

This trial is active, not recruiting.

Condition healthy
Treatments purple wheat crackers, purple wheat granola bars
Sponsor University of Guelph
Start date October 2015
End date April 2016
Trial size 16 participants
Trial identifier NCT02730910, UGuelph

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-availability study
Intervention model crossover assignment
Masking single blind (outcomes assessor)
Primary purpose basic science
Arm
(Experimental)
Bran-enriched purple wheat wholegrain crackers served in 120 g portion.
purple wheat crackers
Whole grain crackers manufactured with purple wheat
(Experimental)
Bran-enriched purple wheat wholegrain granola bars served in 160 g portion.
purple wheat granola bars
Whole grain granola bars manufactured with purple wheat

Primary Outcomes

Measure
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

Measure
Plasma concentrations of phenolic acids
time frame: 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)
Urinary concentrations of phenolic acids
time frame: 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)

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Guelph.