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Effects of Avenanthramide-enriched Oats on Inflammation

Primary Purpose

Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Avenanthramide-enriched oats
Refined flour absent avenanthramides
Sponsored by
Tufts University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Inflammation

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Avenanthramide-enriched oat muffin

Refined flour muffin

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

Full Information

First Posted
January 30, 2012
Last Updated
November 18, 2014
Sponsor
Tufts University
Collaborators
Agriculture and Agri-Food Canada
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1. Study Identification

Unique Protocol Identification Number
NCT01527604
Brief Title
Effects of Avenanthramide-enriched Oats on Inflammation
Official Title
Effects of Avenanthramide-enriched Oats on Inflammation in Obese Adults With Central Adiposity: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts University
Collaborators
Agriculture and Agri-Food Canada

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Avenanthramide-enriched oat muffin
Arm Type
Active Comparator
Arm Title
Refined flour muffin
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Avenanthramide-enriched oats
Intervention Description
avenanthramide-enriched oats, delivered as muffins at a dose of 2 muffins per day for 56 days.
Intervention Type
Other
Intervention Name(s)
Refined flour absent avenanthramides
Intervention Description
refined flour absent avenanthramides, delivered as muffins at a dose of 2 muffins per day for 56 days.
Primary Outcome Measure Information:
Title
Change in biomarkers of inflammation compared with placebo
Description
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).
Time Frame
Baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Change in biomarkers of glucoregulation, plasma lipids, and blood pressure compared with placebo
Description
Secondary outcomes will include plasma markers of glucoregulation (fasting glucose, insulin, HOMA), plasma lipids (total cholesterol, HDL, LDL, triglycerides), and blood pressure (BP).
Time Frame
Baseline and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diane L. McKay, PhD
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

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Effects of Avenanthramide-enriched Oats on Inflammation

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