Effects of Avenanthramide-enriched Oats on Inflammation

Study Overview
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Brief Summary
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The objective of this randomized, double-blinded, placebo-controlled, parallel trial is to determine whether consuming avenanthramide-enriched oats daily for 8 weeks on can improve biomarkers of inflammation in older, obese adults.

Official Title
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Effects of Avenanthramide-enriched Oats on Inflammation in Obese Adults With Central Adiposity: A Randomized Clinical Trial

Conditions
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Inflammation

Intervention / Treatment
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* Other: Avenanthramide-enriched oats
* Other: Refined flour absent avenanthramides


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men & postmenopausal women, age 50 years and over BMI 30-36 kg/m2 waist:hip ratio > 0.8 for women, > 0.9 for men Exclusion Criteria: Cigarette smoking and/or nicotine replacement use Individuals taking estrogen Use of cholesterol-lowering medications Use of blood pressure-lowering medications Regular use of any stomach acid-lowering medications, laxatives (including fiber supplements) or anti-diarrheal medications(prescription or over-the-counter [OTC]) Cardiovascular (heart) disease Gastrointestinal disease Kidney disease Endocrine disease: including diabetes, untreated thyroid disease Rheumatoid arthritis Active treatment for any type of cancer, except basal cell carcinoma, within 1 year prior to study admission Systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 95 mmHg Regular use of oral steroids Regular daily intake of ≥ 2 alcoholic drinks Strict vegetarians No dietary supplements, including those containing any vitamins, minerals, herbs, plant concentrates (including garlic, gingko, St. John's wort) homeopathic remedies, probiotics, or fish oil (including cod liver oil), for one month prior to study admission

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Avenanthramide-enriched oat muffin<br> | Other: Avenanthramide-enriched oats<br>* avenanthramide-enriched oats, delivered as muffins at a dose of 2 muffins per day for 56 days.<br>|
| Placebo Comparator: Refined flour muffin<br> | Other: Refined flour absent avenanthramides<br>* refined flour absent avenanthramides, delivered as muffins at a dose of 2 muffins per day for 56 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in biomarkers of inflammation compared with placebo | 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). | Baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in biomarkers of glucoregulation, plasma lipids, and blood pressure compared with placebo | Secondary outcomes will include plasma markers of glucoregulation (fasting glucose, insulin, HOMA), plasma lipids (total cholesterol, HDL, LDL, triglycerides), and blood pressure (BP). | Baseline and 8 weeks |