Clinical Assessment of Barley and Oat Phytochemicals

This study has been completed.
Sponsor:
Collaborator:
Kellogg Company
Information provided by (Responsible Party):
Tufts University
ClinicalTrials.gov Identifier:
NCT01303562
First received: November 16, 2010
Last updated: May 23, 2013
Last verified: May 2013
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Tufts University
ClinicalTrials.gov Identifier: NCT01303562     History of Changes
Other Study ID Numbers: IRB 9571
Study First Received: November 16, 2010
Last Updated: May 23, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 16, 2014