Clinical Assessment of Barley and Oat Phytochemicals

NCT ID: NCT01303562

Last Updated: 2013-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2013-02-28

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).

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Placebo muffin made with no whole grains

Group Type: PLACEBO_COMPARATOR

Whole grain oats and barley

Intervention Type: OTHER

One time dose of 48 g whole grain flour in 2 small muffins (24 g flour per muffin) per intervention

Test muffin made with whole oats

Group Type: ACTIVE_COMPARATOR

Whole grain oats and barley

Intervention Type: OTHER

One time dose of 48 g whole grain flour in 2 small muffins (24 g flour per muffin) per intervention

Test muffin made with whole barley

Group Type: ACTIVE_COMPARATOR

Whole grain oats and barley

Intervention Type: OTHER

One time dose of 48 g whole grain flour in 2 small muffins (24 g flour per muffin) per intervention

Interventions

Whole grain oats and barley

One time dose of 48 g whole grain flour in 2 small muffins (24 g flour per muffin) per intervention

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kellogg Company

INDUSTRY

Sponsor Role: collaborator

Tufts University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey B Blumberg, PhD

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Locations

Tufts Clinical and Translational Research Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

IRB 9571

Identifier Type: -

Identifier Source: org_study_id