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Effects of Avenanthramide-enriched Oats on Inflammation

NCT ID: NCT01527604

Last Updated: 2014-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Avenanthramide-enriched oat muffin

Group Type ACTIVE_COMPARATOR

Avenanthramide-enriched oats

Intervention Type OTHER

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

Refined flour muffin

Group Type PLACEBO_COMPARATOR

Refined flour absent avenanthramides

Intervention Type OTHER

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

Interventions

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Avenanthramide-enriched oats

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

Intervention Type OTHER

Refined flour absent avenanthramides

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Agriculture and Agri-Food Canada

OTHER_GOV

Sponsor Role collaborator

Tufts University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Diane L. McKay, PhD

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Locations

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

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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IRB9930

Identifier Type: -

Identifier Source: org_study_id