Impact of Purple Wheat Consumption on Markers of Inflammation and Oxidative Stress in Adults.

March 29, 2018 updated by: Amanda Wright, Ph.D., University of Guelph

The Purple Wheat Intervention Study: Impact of Purple Wheat Consumption on Markers of Inflammation and Oxidative Stress in Adults.

The main purpose of this study is to determine the effect of consumption of purple wheat anthocyanin-rich products for eight weeks by human participants with an elevated level of chronic inflammation, on oxidative stress and inflammatory responses as measured by select plasma biomarkers.

Study Overview

Detailed Description

This study will investigate the effect of daily consumption of purple wheat bran-enriched wholegrain convenience bars, for 8 weeks on inflammation and oxidative stress biomarkers and plasma antioxidant capacity. This study is a randomized, parallel arm study with 20 men and 20 women who will adhere to a low anthocyanin and low phenolic aid diet for the duration of the study. The participants will be randomly divided into two groups, using stratification for matching sex and screening hs-CRP level to be equally distributed in each group, and assigned to either the treatment group or control group. Both group will have a 10 day diet run-in period where consumption of foods rich in anthocyanins and phenolic acids will be limited. Both groups will consume 4 servings of wheat products per day for 8 weeks and will replace 4 grain servings from their typical daily intake with the study treatment products. Fasting blood samples will be collected during three study visits, including baseline, for the analysis of inflammatory and oxidative stress biomarkers and plasma antioxidant capacity. The plasma metabolites of anthocyanins and phenolic acids will also be determined.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Guelph, Ontario, Canada, N1G 2W1
        • Human Nutraceutical Research Unit, University of Guelph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI ≥ 25 kg/m2 and/or Waist circumference ≥102 cm (men) and ≥88 cm (women)
  • hs-CRP: ≥ 1.0 mg/L at time of screening
  • Stable (>3 months) and consistent use of all prescribed medications and/or supplements
  • Non- to moderate alcohol consumer (i.e. less than 5 drinks per sitting and no more than 14 per week)
  • Not taking any antibiotics within the last 3 months, or planning to take antibiotics within the next 6 months

Exclusion Criteria:

  • Pregnant or breastfeeding females
  • Lifetime history of any acute medical event, including but not limited to, heart attack or stroke
  • Occasional or intermittent smoker (includes but not limited to tobacco and cannabis)
  • Consistent smoker of <1 year
  • Recent diagnosis (within 6 months) of a serious medical condition, including but not limited to, cancer, diabetes, heart disease or hepatitis
  • Recent history (within 6 months) of a clinically significant psychiatric disorder, other than mild depression
  • Any disorder of the gastrointestinal system or food intolerances, including but not limited to, inflammatory bowel disease or Celiac disease
  • Any food allergies or any life-threatening allergies, food or otherwise
  • Regular recreational drug use of more than once per week, including but not limited to cannabis, magic mushrooms, ecstasy etc
  • Difficulty providing blood samples

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment Group
Purple Wheat Convenience Bars The treatment group will consume 4 servings /day of bran-enriched purple wheat convenience bars (40g/ serving)
Whole grain convenience bars manufactured with purple wheat
PLACEBO_COMPARATOR: Control Group
Control Wheat Convenience Bars The control group will consume 4 servings /day of bran-enriched ordinary wheat convenience basr (40g/ serving)
Whole grain convenience bars manufactured with ordinary wheat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum concentration of inflammatory biomarker (hs-CRP)
Time Frame: Fasting (0 hours)
Fasting (0 hours)

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma concentration of lipids
Time Frame: Fasting (0 hours)
Fasting (0 hours)
Plasma concentration of inflammatory biomarkers
Time Frame: Fasting (0 hours)
Fasting (0 hours)
Plasma concentration of total antioxidant capacity
Time Frame: Fasting (0 hours)
Fasting (0 hours)
Plasma concentrations of anthocyanin metabolites and phenolic acids
Time Frame: Fasting (0 hours)
Fasting (0 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (ACTUAL)

July 1, 2017

Study Completion (ACTUAL)

December 1, 2017

Study Registration Dates

First Submitted

July 19, 2016

First Submitted That Met QC Criteria

July 19, 2016

First Posted (ESTIMATE)

July 21, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 2, 2018

Last Update Submitted That Met QC Criteria

March 29, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PWIS2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Through peer reviewed publications.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Purple Wheat Convenience Bars

3
Subscribe