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Bioavailability of Avenanthramide-Enriched Oats in Healthy Older Adults

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ClinicalTrials.gov Identifier: NCT01055717
Recruitment Status : Completed
First Posted : January 26, 2010
Last Update Posted : May 27, 2013
Sponsor:
Collaborator:
Agriculture and Agri-Food Canada
Information provided by (Responsible Party):
Tufts University

Brief Summary:
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 or disease Intervention/treatment
Healthy Other: Avenanthramide-enriched oats

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
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
Study Start Date : March 2010
Primary Completion Date : December 2010
Study Completion Date : January 2011

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]


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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

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

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

Keywords provided by Tufts University:
avenanthramide
enriched
oat
phytochemical
bioavailability