Clinical Assessment of Barley and Oat Phytochemicals

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Whole grain oats and barley

• Registration Number: NCT01303562
• Lead Sponsor: Tufts University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-11-16
• Study First Submitted QC: 2011-02-23
• Study First Posted: 2011-02-24
• Primary Completion: 2011-04
• Study Completion: 2013-02
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-23
• Last Update Posted: 2013-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Men and postmenopausal women
• BMI 27-35.9 kg/m2

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo muffin made with no whole grains	Whole grain oats and barley	-
Test muffin made with whole oats	Whole grain oats and barley	-
Test muffin made with whole barley	Whole grain oats and barley	-

Primary Outcome Measures

Name	Time	Method
Levels of phytochemicals and their in vivo metabolites in blood	24 hours	Levels of phytochemicals and their in vivo metabolites in blood, urine, and feces following the consumption of whole grains delivered in a baked muffin

Trial Locations

Locations (1)

Tufts Clinical and Translational Research Center; 🇺🇸 Boston, Massachusetts, United States