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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Purple Wheat Convenience Bars The treatment group will consume 4 servings /day of bran-enriched purple wheat convenience bars (40g/ serving) |
|
| Control Group | Placebo Comparator | Control Wheat Convenience Bars The control group will consume 4 servings /day of bran-enriched ordinary wheat convenience basr (40g/ serving) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Purple Wheat Convenience Bars | Other | Whole grain convenience bars manufactured with purple wheat |
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| Measure | Description | Time Frame |
|---|---|---|
| Serum concentration of inflammatory biomarker (hs-CRP) | Fasting (0 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of lipids | Fasting (0 hours) | |
| Plasma concentration of inflammatory biomarkers | Fasting (0 hours) | |
| Plasma concentration of total antioxidant capacity |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Nutraceutical Research Unit, University of Guelph | Guelph | Ontario | N1G 2W1 | Canada |
Through peer reviewed publications.
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Control Wheat Convenience Bars | Other | Whole grain convenience bars manufactured with ordinary wheat |
|
| Fasting (0 hours) |
| Plasma concentrations of anthocyanin metabolites and phenolic acids | Fasting (0 hours) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |