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

University of Guelph

Status

Completed

Conditions

Healthy

Treatments

Other: Control Wheat Convenience Bars

Other: Purple Wheat Convenience Bars

Study type

Interventional

Funder types

Other

Identifiers

NCT02840357

PWIS2

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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