We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Assessment of Barley and Oat Phytochemicals

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01303562
First Posted: February 24, 2011
Last Update Posted: May 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Kellogg Company
Information provided by (Responsible Party):
Tufts University
  Purpose
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).

Condition Intervention
Healthy Other: Whole grain oats and barley

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Clinical Assessment of Barley and Oat Phytochemicals: Acute Bioavailability, Pharmacokinetics, and Bioactivity

Further study details as provided by Tufts University:

Primary Outcome Measures:
  • 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


Enrollment: 13
Study Start Date: September 2010
Study Completion Date: February 2013
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01303562


Locations
United States, Massachusetts
Tufts Clinical and Translational Research Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
Kellogg Company
Investigators
Principal Investigator: Jeffrey B Blumberg, PhD Tufts Medical Center
  More Information

Responsible Party: Tufts University
ClinicalTrials.gov Identifier: NCT01303562     History of Changes
Other Study ID Numbers: IRB 9571
First Submitted: November 16, 2010
First Posted: February 24, 2011
Last Update Posted: May 27, 2013
Last Verified: May 2013

Keywords provided by Tufts University:
oat
barley
whole grain
bioavailability
phytochemical