Inflammation
Conditions
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.
Interventions
avenanthramide-enriched oats, delivered as muffins at a dose of 2 muffins per day for 56 days.
OTHERRefined flour absent avenanthramides
refined flour absent avenanthramides, delivered as muffins at a dose of 2 muffins per day for 56 days.
Sponsors
Agriculture and Agri-Food Canada
Tufts University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in biomarkers of inflammation compared with placebo | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in biomarkers of glucoregulation, plasma lipids, and blood pressure compared with placebo | 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). |
Countries
United States
Outcome results
None listed