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Bioavailability of Avenanthramide-Enriched Oats in Healthy Older Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01055717
First Posted: January 26, 2010
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:
Agriculture and Agri-Food Canada
Information provided by (Responsible Party):
Tufts University
  Purpose
This is a placebo-controlled, crossover study investigating the pharmacokinetic bioavailability of avenanthramides from avenanthramide-enriched oats and their in vivo metabolites in a cohort of healthy, older adults.

Condition Intervention
Healthy Other: Avenanthramide-enriched oats

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Bioavailability of Avenanthramide-Enriched Oats in Healthy Older Adults

Further study details as provided by Tufts University:

Primary Outcome Measures:
  • Levels of avenanthramides and their in vivo metabolites in blood, urine, and feces following the consumption of avenanthramide-enriched oats delivered in a baked muffin [ Time Frame: 24 hours ]

Enrollment: 12
Study Start Date: March 2010
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo muffin made with no oats Other: Avenanthramide-enriched oats
Single dose, 24 hour pharmacokinetic trial
Active Comparator: Test muffin made with AV-enriched oats Other: Avenanthramide-enriched oats
Single dose, 24 hour pharmacokinetic trial

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and postmenopausal women
  • BMI 18.5-29.9 kg/m2

Exclusion Criteria:

  • Cigarette smoking and/or nicotine replacement use
  • Use of cholesterol-lowering medications
  • Use of blood pressure-lowering medications
  • Use of any stomach acid-lowering medications
  • 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 mm Hg and/or diastolic blood pressure > 95 mm Hg
  • Regular use of oral steroids
  • Regular daily intake of 2 or more alcoholic drinks
  • Illicit drug use
  • 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): NCT01055717


Locations
United States, Massachusetts
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
Agriculture and Agri-Food Canada
Investigators
Principal Investigator: Jeffrey B Blumberg, PhD Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts Unversity
  More Information

Responsible Party: Tufts University
ClinicalTrials.gov Identifier: NCT01055717     History of Changes
Other Study ID Numbers: IRB9306
First Submitted: January 25, 2010
First Posted: January 26, 2010
Last Update Posted: May 27, 2013
Last Verified: May 2013

Keywords provided by Tufts University:
avenanthramide
enriched
oat
phytochemical
bioavailability