Clinical Assessment of Barley and Oat Phytochemicals

Study Overview
=================
Brief Summary
-----------------
The goal of this placebo-controlled, 3-way crossover study is to determine the acute (24-h) bioavailability and pharmacokinetics of the major phytochemicals found whole barley and oats, as well as their effects on selected measures of antioxidation, inflammation, insulin sensitivity/glucose regulation, and vascular remodeling following challenge by an oral glucose tolerance test (OGTT).

Official Title
-----------------
Clinical Assessment of Barley and Oat Phytochemicals: Acute Bioavailability, Pharmacokinetics, and Bioactivity

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: Whole grain oats and barley


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and postmenopausal women BMI 27-35.9 kg/m2 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 or laxatives (including fiber supplements) 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 Infrequent or excessive number of regular bowel movements Illicit drug use Vegetarians No fish oil supplements (including cod liver oil) for one month prior to study admission No dietary supplements, including those containing any vitamins, minerals, herbs, plant concentrates (including garlic, gingko, St. John's wort) or homeopathic remedies, for one month prior to study admission

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo muffin made with no whole grains<br> | Other: Whole grain oats and barley<br>* One time dose of 48 g whole grain flour in 2 small muffins (24 g flour per muffin) per intervention<br>|
| Active Comparator: Test muffin made with whole oats<br> | Other: Whole grain oats and barley<br>* One time dose of 48 g whole grain flour in 2 small muffins (24 g flour per muffin) per intervention<br>|
| Active Comparator: Test muffin made with whole barley<br> | Other: Whole grain oats and barley<br>* One time dose of 48 g whole grain flour in 2 small muffins (24 g flour per muffin) per intervention<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of phytochemicals and their in vivo metabolites in blood | Levels of phytochemicals and their in vivo metabolites in blood, urine, and feces following the consumption of whole grains delivered in a baked muffin | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oat, barley, whole grain, bioavailability, phytochemical