Bioavailability of Avenanthramide-Enriched Oats in Healthy Older Adults

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Avenanthramide-enriched oats

• Registration Number: NCT01055717
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-25
• Study First Submitted QC: 2010-01-25
• Study First Posted: 2010-01-26
• Study Start: 2010-03
• Primary Completion: 2010-12
• Study Completion: 2011-01
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-23
• Last Update Posted: 2013-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test muffin made with AV-enriched oats	Avenanthramide-enriched oats	-
Placebo muffin made with no oats	Avenanthramide-enriched oats	-

Primary Outcome Measures

Name	Time	Method
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	24 hours

Trial Locations

Locations (1)

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University; 🇺🇸 Boston, Massachusetts, United States