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

January 30, 2012
January 27, 2014
December 2012
February 2015   (final data collection date for primary outcome measure)
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).
Change in biomarkers of inflammation compared with placebo [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01527604 on ClinicalTrials.gov Archive Site
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).
Change in biomarkers of glucoregulation, plasma lipids, and blood pressure compared with placebo [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
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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.

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Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Inflammation
  • Other: Avenanthramide-enriched oats
    avenanthramide-enriched oats, delivered as muffins at a dose of 2 muffins per day for 56 days.
  • Other: Refined flour absent avenanthramides
    refined flour absent avenanthramides, delivered as muffins at a dose of 2 muffins per day for 56 days.
  • Active Comparator: Avenanthramide-enriched oat muffin
    Intervention: Other: Avenanthramide-enriched oats
  • Placebo Comparator: Refined flour muffin
    Intervention: Other: Refined flour absent avenanthramides
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
16
Not Provided
February 2015   (final data collection date for primary outcome measure)

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
Both
50 Years and older
Yes
Contact: Diane L. McKay, PhD 781-608-7183 diane.mckay@tufts.edu
Contact: Jeffrey B. Blumberg, PhD 617-556-3334 jeffrey.blumberg@tufts.edu
United States
 
NCT01527604
IRB9930
Not Provided
Tufts University
Tufts University
Agriculture and Agri-Food Canada
Principal Investigator: Diane L. McKay, PhD Tufts Medical Center
Tufts University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP