Effects of Avenanthramide-enriched Oats on Inflammation

Tufts University

Status: Completed

Conditions: Inflammation

Treatments: Other: Refined flour absent avenanthramides; Other: Avenanthramide-enriched oats

Study type: Interventional

Funder types: Other

Identifiers

NCT01527604

IRB9930

Details and patient eligibility

About

The objective of this randomized, double-blinded, placebo-controlled, parallel trial is to determine whether consuming avenanthramide-enriched oats daily for 8 weeks on can improve biomarkers of inflammation in older, obese adults.

Enrollment: 16 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Men & postmenopausal women, age 50 years and over
• BMI 30-36 kg/m2
• waist:hip ratio > 0.8 for women, > 0.9 for men

Exclusion criteria

• Cigarette smoking and/or nicotine replacement use
• Individuals taking estrogen
• Use of cholesterol-lowering medications
• Use of blood pressure-lowering medications
• Regular use of any stomach acid-lowering medications, laxatives (including fiber supplements) or anti-diarrheal medications(prescription or over-the-counter [OTC])
• 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 mmHg and/or diastolic blood pressure > 95 mmHg
• Regular use of oral steroids
• Regular daily intake of ≥ 2 alcoholic drinks
• Strict vegetarians
• No dietary supplements, including those containing any vitamins, minerals, herbs, plant concentrates (including garlic, gingko, St. John's wort) homeopathic remedies, probiotics, or fish oil (including cod liver oil), for one month prior to study admission

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16 participants in 2 patient groups, including a placebo group

Avenanthramide-enriched oat muffin

Active Comparator group

Treatment:

Other: Avenanthramide-enriched oats

Refined flour muffin

Placebo Comparator group

Treatment:

Other: Refined flour absent avenanthramides