Effects of Avenanthramide-enriched Oats on Inflammation

Effects of Avenanthramide-enriched Oats on Inflammation in Obese Adults With Central Adiposity: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Inflammation
• Intervention / Treatment: Other: Avenanthramide-enriched oats; Other: Refined flour absent avenanthramides

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Avenanthramide-enriched oat muffin	Other: Avenanthramide-enriched oats; avenanthramide-enriched oats, delivered as muffins at a dose of 2 muffins per day for 56 days.
Placebo Comparator: Refined flour muffin	Other: Refined flour absent avenanthramides; refined flour absent avenanthramides, delivered as muffins at a dose of 2 muffins per day for 56 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in biomarkers of inflammation compared with placebo	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).	Baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in biomarkers of glucoregulation, plasma lipids, and blood pressure compared with placebo	Secondary outcomes will include plasma markers of glucoregulation (fasting glucose, insulin, HOMA), plasma lipids (total cholesterol, HDL, LDL, triglycerides), and blood pressure (BP).	Baseline and 8 weeks

Collaborators and Investigators

• Sponsor: Tufts University
• Collaborators: Agriculture and Agri-Food Canada
• Investigators: Principal Investigator: Diane L. McKay, PhD, Tufts Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: January 30, 2012
• First Submitted That Met QC Criteria: February 2, 2012
• First Posted (Estimate): February 7, 2012

Study Record Updates

• Last Update Posted (Estimate): November 19, 2014
• Last Update Submitted That Met QC Criteria: November 18, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: IRB9930