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Effects of Avenanthramide-enriched Oats on Inflammation

Not Applicable
Completed
Conditions
Inflammation
Interventions
Other: Avenanthramide-enriched oats
Other: Refined flour absent avenanthramides
Registration Number
NCT01527604
Lead Sponsor
Tufts University
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
16
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Avenanthramide-enriched oat muffinAvenanthramide-enriched oats-
Refined flour muffinRefined flour absent avenanthramides-
Primary Outcome Measures
NameTimeMethod
Change in biomarkers of inflammation compared with placeboBaseline and 8 weeks

Primary outcome measures will include selected biomarkers of inflammation in blood, i.e., pro-inflammatory cytokines, chemokines, as well as other inflammatory markers (i.e., high sensitivity C-reactive protein).

Secondary Outcome Measures
NameTimeMethod
Change in biomarkers of glucoregulation, plasma lipids, and blood pressure compared with placeboBaseline and 8 weeks

Secondary outcomes will include plasma markers of glucoregulation (fasting glucose, insulin, HOMA), plasma lipids (total cholesterol, HDL, LDL, triglycerides), and blood pressure (BP).

Trial Locations

Locations (1)

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

🇺🇸

Boston, Massachusetts, United States

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