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Bioavailability of Avenanthramide-Enriched Oats in Healthy Older Adults

This study has been completed.
Sponsor:
Collaborator:
Agriculture and Agri-Food Canada
Information provided by (Responsible Party):
Tufts University
ClinicalTrials.gov Identifier:
NCT01055717
First received: January 25, 2010
Last updated: May 23, 2013
Last verified: May 2013
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Tufts University
ClinicalTrials.gov Identifier: NCT01055717     History of Changes
Other Study ID Numbers: IRB9306
Study First Received: January 25, 2010
Last Updated: May 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts University:
avenanthramide
enriched
oat
phytochemical
bioavailability

ClinicalTrials.gov processed this record on November 25, 2014