Effects of Avenanthramide-enriched Oats on Inflammation

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Tufts University
Sponsor:
Collaborator:
Agriculture and Agri-Food Canada
Information provided by (Responsible Party):
Tufts University
ClinicalTrials.gov Identifier:
NCT01527604
First received: January 30, 2012
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Inflammation
Other: Avenanthramide-enriched oats
Other: Refined flour absent avenanthramides

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Effects of Avenanthramide-enriched Oats on Inflammation in Obese Adults With Central Adiposity: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Tufts University:

Primary Outcome Measures:
  • Change in biomarkers of inflammation compared with placebo [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
    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:
  • Change in biomarkers of glucoregulation, plasma lipids, and blood pressure compared with placebo [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
    Secondary outcomes will include plasma markers of glucoregulation (fasting glucose, insulin, HOMA), plasma lipids (total cholesterol, HDL, LDL, triglycerides), and blood pressure (BP).


Estimated Enrollment: 16
Study Start Date: December 2012
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01527604

Contacts
Contact: Diane L. McKay, PhD 781-608-7183 diane.mckay@tufts.edu
Contact: Jeffrey B. Blumberg, PhD 617-556-3334 jeffrey.blumberg@tufts.edu

Locations
United States, Massachusetts
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University Recruiting
Boston, Massachusetts, United States, 02111
Principal Investigator: Diane L. McKay, PhD         
Sub-Investigator: Jeffrey B. Blumberg, PhD         
Sponsors and Collaborators
Tufts University
Agriculture and Agri-Food Canada
Investigators
Principal Investigator: Diane L. McKay, PhD Tufts Medical Center
  More Information

No publications provided

Responsible Party: Tufts University
ClinicalTrials.gov Identifier: NCT01527604     History of Changes
Other Study ID Numbers: IRB9930
Study First Received: January 30, 2012
Last Updated: January 27, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014