Clinical Assessment of Barley and Oat Phytochemicals

Tufts University

Status: Completed

Conditions: Healthy

Treatments: Other: Whole grain oats and barley

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01303562

IRB 9571

Details and patient eligibility

About

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).

Enrollment: 13 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

13 participants in 3 patient groups, including a placebo group

Placebo muffin made with no whole grains

Placebo Comparator group

Treatment:

Other: Whole grain oats and barley

Test muffin made with whole oats

Active Comparator group

Treatment:

Other: Whole grain oats and barley

Test muffin made with whole barley

Active Comparator group

Treatment:

Other: Whole grain oats and barley