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Effects of Avenanthramide-enriched Oats on Inflammation

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ClinicalTrials.gov Identifier: NCT01527604
Recruitment Status : Completed
First Posted : February 7, 2012
Last Update Posted : November 19, 2014
Sponsor:
Collaborator:
Agriculture and Agri-Food Canada
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Inflammation Other: Avenanthramide-enriched oats Other: Refined flour absent avenanthramides Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effects of Avenanthramide-enriched Oats on Inflammation in Obese Adults With Central Adiposity: A Randomized Clinical Trial
Study Start Date : December 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01527604


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

Responsible Party: Tufts University
ClinicalTrials.gov Identifier: NCT01527604     History of Changes
Other Study ID Numbers: IRB9930
First Posted: February 7, 2012    Key Record Dates
Last Update Posted: November 19, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Inflammation
Pathologic Processes