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Effects of Avenanthramide-enriched Oats on Inflammation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01527604
First Posted: February 7, 2012
Last Update Posted: November 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Agriculture and Agri-Food Canada
Information provided by (Responsible Party):
Tufts University
January 30, 2012
February 7, 2012
November 19, 2014
December 2012
June 2014   (Final data collection date for primary outcome measure)
Change in biomarkers of inflammation compared with placebo [ Time Frame: Baseline 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).
Change in biomarkers of inflammation compared with placebo [ Time Frame: Baseline and 8 weeks ]
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 ]
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 ]
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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
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
 
Completed
16
June 2014
June 2014   (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
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01527604
IRB9930
Not Provided
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Tufts University
Tufts University
Agriculture and Agri-Food Canada
Principal Investigator: Diane L. McKay, PhD Tufts Medical Center
Tufts University
November 2014

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