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Bioavailability of Avenanthramide-Enriched Oats in Healthy Older Adults

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Tufts University

Status

Completed

Conditions

Healthy

Treatments

Other: Avenanthramide-enriched oats

Study type

Interventional

Funder types

Other

Identifiers

NCT01055717
IRB9306

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

50 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

12 participants in 2 patient groups, including a placebo group

Placebo muffin made with no oats
Placebo Comparator group
Treatment:
Other: Avenanthramide-enriched oats
Test muffin made with AV-enriched oats
Active Comparator group
Treatment:
Other: Avenanthramide-enriched oats

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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