NCT01055717CompletedNot Applicable
Bioavailability of Avenanthramide-Enriched Oats in Healthy Older Adults
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tufts University
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 50 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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