InflammationNCT01527604
Effects of Avenanthramide-enriched Oats on Inflammation
A study testing Avenanthramide-enriched oats and Refined flour absent avenanthramides in people with Inflammation, run by Tufts University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- Avenanthramide-enriched oats and Refined flour absent avenanthramides
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men \& postmenopausal women, age 50 years and over
- BMI 30-36 kg/m2
- waist:hip ratio > 0.8 for women, > 0.9 for men
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111
About this study
Official title: Effects of Avenanthramide-enriched Oats on Inflammation in Obese Adults With Central Adiposity: A Randomized Clinical Trial
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.
- Conditions
- Inflammation
- Being tested
- Avenanthramide-enriched oats, Refined flour absent avenanthramides
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avenanthramide-enriched oatsOther
avenanthramide-enriched oats, delivered as muffins at a dose of 2 muffins per day for 56 days.
Refined flour absent avenanthramidesOther
refined flour absent avenanthramides, delivered as muffins at a dose of 2 muffins per day for 56 days.
| Study group | Role | What they receive |
|---|---|---|
| Avenanthramide-enriched oat muffin | Active comparator | Not described Receives: Other: Avenanthramide-enriched oats |
| Refined flour muffin | Placebo comparator | Not described Receives: Other: Refined flour absent avenanthramides |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and 8 weeks
Secondary outcomes (1)
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).
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2012 (estimated)
- Study startDec 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Agriculture and Agri-Food Canada
- Responsible party
- Sponsor
- Investigators
- Diane L. McKay, PhD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527604
- Sponsor's protocol ID
- IRB9930
- Status last verified
- Nov 2014
- First submitted
- 30 Jan 2012
- Last updated
- 19 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Avenanthramide-enriched Oats on Inflammation in Obese Adults With Central Adiposity: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01527604
- Acronym / sponsor ID
- IRB9930
- Conditions
- Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Agriculture and Agri-Food Canada
- Study start
- Dec 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 7 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Avenanthramide-enriched oat muffin | Active comparator | Other: Avenanthramide-enriched oats |
| Refined flour muffin | Placebo comparator | Other: Refined flour absent avenanthramides |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men \& postmenopausal women, age 50 years and over
- BMI 30-36 kg/m2
- waist:hip ratio > 0.8 for women, > 0.9 for men
Key exclusion criteria (16 listed)
- 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])
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avenanthramide-enriched oatsavenanthramide-enriched oats, delivered as muffins at a dose of 2 muffins per day for 56 days. | Other | Avenanthramide-enriched oat muffin |
| Refined flour absent avenanthramidesrefined flour absent avenanthramides, delivered as muffins at a dose of 2 muffins per day for 56 days. | Other | Refined flour muffin |
Primary outcome
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).
1 secondary outcome
Change in biomarkers of glucoregulation, plasma lipids, and blood pressure compared with placebo
Time frame: Baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diane L. McKay, PhD principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avenanthramide-enriched oats and Refined flour absent avenanthramides in people with Inflammation, run by Tufts University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in biomarkers of inflammation compared with placebo (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2014.