Clinical Assessment of Barley and Oat Phytochemicals

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01303562

Enrollment

Registered

2011-02-24

Start date

2010-09-30

Completion date

2013-02-28

Last updated

2013-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

oat, barley, whole grain, bioavailability, phytochemical

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).

Interventions

OTHERWhole grain oats and barley

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026