Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2025-12-24 @ 7:08 PM
NCT ID:
NCT02840357
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.
Study:
NCT02840357
Study Brief:
Protocol Section:
NCT02840357