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Completed

NCT Number: NCT01527604

Effects of Avenanthramide-enriched Oats on Inflammation

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.

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Key information

Conditions

Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, 02111, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Avenanthramide-enriched oats

Other

avenanthramide-enriched oats, delivered as muffins at a dose of 2 muffins per day for 56 days.

Refined flour absent avenanthramides

Other

refined flour absent avenanthramides, delivered as muffins at a dose of 2 muffins per day for 56 days.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Collaborators

  • Agriculture and Agri-Food Canada

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 7, 2012
Registry last updated
Nov 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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