Clinical Assessment of Barley and Oat Phytochemicals

May 23, 2013 updated by: Tufts University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Clinical and Translational Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo muffin made with no whole grains
Other: 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
Active Comparator: Test muffin made with whole oats
Other: 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
Active Comparator: Test muffin made with whole barley
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Levels of phytochemicals and their in vivo metabolites in blood
Time Frame: 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
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts University

Collaborators

Kellogg Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

November 16, 2010

First Submitted That Met QC Criteria

February 23, 2011

First Posted (Estimate)

February 24, 2011

Study Record Updates

Last Update Posted (Estimate)

May 27, 2013

Last Update Submitted That Met QC Criteria

May 23, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB 9571

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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