Back to resultsImpact of Purple Wheat Consumption on Markers of Inflammation and Oxidative Stress in Adults.
Primary Purpose
Healthy
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Purple Wheat Convenience Bars
Control Wheat Convenience Bars
Sponsored by
About this trial
This is an interventional basic science trial for Healthy focused on measuring Chronic inflammation, Adults, overweight, obese
Eligibility 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
Sites / Locations
- Human Nutraceutical Research Unit, University of Guelph
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment Group
Control Group
Arm Description
Purple Wheat Convenience Bars The treatment group will consume 4 servings /day of bran-enriched purple wheat convenience bars (40g/ serving)
Control Wheat Convenience Bars The control group will consume 4 servings /day of bran-enriched ordinary wheat convenience basr (40g/ serving)
Outcomes
Primary Outcome Measures
Serum concentration of inflammatory biomarker (hs-CRP)
Secondary Outcome Measures
Plasma concentration of lipids
Plasma concentration of inflammatory biomarkers
Plasma concentration of total antioxidant capacity
Plasma concentrations of anthocyanin metabolites and phenolic acids
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02840357
Brief Title
Impact of Purple Wheat Consumption on Markers of Inflammation and Oxidative Stress in Adults.
Official Title
The Purple Wheat Intervention Study: Impact of Purple Wheat Consumption on Markers of Inflammation and Oxidative Stress in Adults.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
July 1, 2017 (Actual)
Study Completion Date
December 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guelph
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Chronic inflammation, Adults, overweight, obese
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Purple Wheat Convenience Bars The treatment group will consume 4 servings /day of bran-enriched purple wheat convenience bars (40g/ serving)
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Control Wheat Convenience Bars The control group will consume 4 servings /day of bran-enriched ordinary wheat convenience basr (40g/ serving)
Intervention Type
Other
Intervention Name(s)
Purple Wheat Convenience Bars
Intervention Description
Whole grain convenience bars manufactured with purple wheat
Intervention Type
Other
Intervention Name(s)
Control Wheat Convenience Bars
Intervention Description
Whole grain convenience bars manufactured with ordinary wheat
Primary Outcome Measure Information:
Title
Serum concentration of inflammatory biomarker (hs-CRP)
Time Frame
Fasting (0 hours)
Secondary Outcome Measure Information:
Title
Plasma concentration of lipids
Time Frame
Fasting (0 hours)
Title
Plasma concentration of inflammatory biomarkers
Time Frame
Fasting (0 hours)
Title
Plasma concentration of total antioxidant capacity
Time Frame
Fasting (0 hours)
Title
Plasma concentrations of anthocyanin metabolites and phenolic acids
Time Frame
Fasting (0 hours)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Human Nutraceutical Research Unit, University of Guelph
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1G 2W1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Through peer reviewed publications.
Learn more about this trial
Impact of Purple Wheat Consumption on Markers of Inflammation and Oxidative Stress in Adults.
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