Effects of Avenanthramide-enriched Oats on Inflammation
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2012
CompletedFirst Posted
Study publicly available on registry
February 7, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedNovember 19, 2014
November 1, 2014
1.5 years
January 30, 2012
November 18, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change in biomarkers of inflammation compared with placebo
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).
Baseline and 8 weeks
Secondary Outcomes (1)
Change in biomarkers of glucoregulation, plasma lipids, and blood pressure compared with placebo
Baseline and 8 weeks
Study Arms (2)
Avenanthramide-enriched oat muffin
ACTIVE COMPARATORRefined flour muffin
PLACEBO COMPARATORInterventions
avenanthramide-enriched oats, delivered as muffins at a dose of 2 muffins per day for 56 days.
refined flour absent avenanthramides, delivered as muffins at a dose of 2 muffins per day for 56 days.
Eligibility Criteria
You may qualify if:
- Men \& postmenopausal women, age 50 years and over
- BMI 30-36 kg/m2
- waist:hip ratio \> 0.8 for women, \> 0.9 for men
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tufts Universitylead
- Agriculture and Agri-Food Canadacollaborator
Study Sites (1)
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Diane L. McKay, PhD
Tufts Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2012
First Posted
February 7, 2012
Study Start
December 1, 2012
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
November 19, 2014
Record last verified: 2014-11