Effects of Avenanthramide-enriched Oats on Inflammation

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01527604
• Other study ID #: IRB9930
• Status: Completed
• Phase: N/A
• First received: January 30, 2012
• Last updated: November 18, 2014
• Start date: December 2012
• Est. completion date: June 2014

Study information

• Verified date: November 2014
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Inflammation

Intervention

Other:
• Avenanthramide-enriched oats
avenanthramide-enriched oats, delivered as muffins at a dose of 2 muffins per day for 56 days.
• Refined flour absent avenanthramides
refined flour absent avenanthramides, delivered as muffins at a dose of 2 muffins per day for 56 days.

Locations

Country	Name	City	State
United States	Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts University	Agriculture and Agri-Food Canada

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in biomarkers of glucoregulation, plasma lipids, and blood pressure compared with placebo	Secondary outcomes will include plasma markers of glucoregulation (fasting glucose, insulin, HOMA), plasma lipids (total cholesterol, HDL, LDL, triglycerides), and blood pressure (BP).	Baseline and 8 weeks	No