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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02840357
Recruitment Status : Completed
First Posted : July 21, 2016
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
Amanda Wright, Ph.D., University of Guelph

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Other: Purple Wheat Convenience Bars Other: Control Wheat Convenience Bars Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Purple Wheat Intervention Study: Impact of Purple Wheat Consumption on Markers of Inflammation and Oxidative Stress in Adults.
Study Start Date : July 2016
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : December 1, 2017

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)
Other: Purple Wheat Convenience Bars
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)
Other: Control Wheat Convenience Bars
Whole grain convenience bars manufactured with ordinary wheat




Primary Outcome Measures :
  1. Serum concentration of inflammatory biomarker (hs-CRP) [ Time Frame: Fasting (0 hours) ]

Secondary Outcome Measures :
  1. Plasma concentration of lipids [ Time Frame: Fasting (0 hours) ]
  2. Plasma concentration of inflammatory biomarkers [ Time Frame: Fasting (0 hours) ]
  3. Plasma concentration of total antioxidant capacity [ Time Frame: Fasting (0 hours) ]
  4. Plasma concentrations of anthocyanin metabolites and phenolic acids [ Time Frame: Fasting (0 hours) ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840357


Locations
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Canada, Ontario
Human Nutraceutical Research Unit, University of Guelph
Guelph, Ontario, Canada, N1G 2W1
Sponsors and Collaborators
University of Guelph
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Responsible Party: Amanda Wright, Ph.D., Amanda Wright, Ph.D, University of Guelph
ClinicalTrials.gov Identifier: NCT02840357    
Other Study ID Numbers: PWIS2
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Through peer reviewed publications.
Keywords provided by Amanda Wright, Ph.D., University of Guelph:
Chronic inflammation
Adults
overweight
obese
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes