Effects of Avenanthramide-enriched Oats on Inflammation

This study is not yet open for participant recruitment.

Verified February 2012 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: February 7, 2012

Last verified: February 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 30, 2012

Last Updated Date

February 7, 2012

Start Date ^ICMJE

February 2012

Estimated Primary Completion Date

February 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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).

Original Primary Outcome Measures ^ICMJE

Change in biomarkers of inflammation compared with placebo [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01527604 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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).

Original Secondary Outcome Measures ^ICMJE

Change in biomarkers of glucoregulation, plasma lipids, and blood pressure compared with placebo [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effects of Avenanthramide-enriched Oats on Inflammation

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science

Condition ^ICMJE

Inflammation

Intervention ^ICMJE

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.

Study Arm (s)

Active Comparator: Avenanthramide-enriched oat muffin
Intervention: Other: Avenanthramide-enriched oats
Placebo Comparator: Refined flour muffin
Intervention: Other: Refined flour absent avenanthramides

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

February 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01527604

Other Study ID Numbers ^ICMJE

IRB9930

Has Data Monitoring Committee

Not Provided

Responsible Party

Tufts University

Study Sponsor ^ICMJE

Tufts University

Collaborators ^ICMJE

Agriculture and Agri-Food Canada

Investigators ^ICMJE

Principal Investigator:

Diane L. McKay, PhD

Tufts Medical Center

Information Provided By

Tufts University

Verification Date

February 2012

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

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