Effects of Avenanthramide-enriched Oats on Inflammation
|ClinicalTrials.gov Identifier: NCT01527604|
Recruitment Status : Completed
First Posted : February 7, 2012
Last Update Posted : November 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Inflammation||Other: Avenanthramide-enriched oats Other: Refined flour absent avenanthramides||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Effects of Avenanthramide-enriched Oats on Inflammation in Obese Adults With Central Adiposity: A Randomized Clinical Trial|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
|Active Comparator: Avenanthramide-enriched oat muffin||
Other: Avenanthramide-enriched oats
avenanthramide-enriched oats, delivered as muffins at a dose of 2 muffins per day for 56 days.
|Placebo Comparator: Refined flour muffin||
Other: Refined flour absent avenanthramides
refined flour absent avenanthramides, delivered as muffins at a dose of 2 muffins per day for 56 days.
- Change in biomarkers of inflammation compared with placebo [ Time Frame: Baseline and 8 weeks ]Primary outcome measures will include selected biomarkers of inflammation in blood, i.e., pro-inflammatory cytokines, chemokines, as well as other inflammatory markers (i.e., high sensitivity C-reactive protein).
- Change in biomarkers of glucoregulation, plasma lipids, and blood pressure compared with placebo [ Time Frame: Baseline and 8 weeks ]Secondary outcomes will include plasma markers of glucoregulation (fasting glucose, insulin, HOMA), plasma lipids (total cholesterol, HDL, LDL, triglycerides), and blood pressure (BP).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01527604
|United States, Massachusetts|
|Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University|
|Boston, Massachusetts, United States, 02111|
|Principal Investigator:||Diane L. McKay, PhD||Tufts Medical Center|