HealthyNCT01303562
Clinical Assessment of Barley and Oat Phytochemicals
A study testing Whole grain oats and barley in people with Healthy, run by Tufts University at 1 site in United States.
Trial summary
The goal of this placebo-controlled, 3-way crossover study is to determine the acute (24-h) bioavailability and pharmacokinetics of the major phytochemicals found whole barley and oats, as well as their effects on selected measures of antioxidation, inflammation, insulin sensitivity/glucose regulation, and vascular… Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Whole grain oats and barley
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Feb 2013
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and postmenopausal women
- BMI 27-35.9 kg/m2
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 or laxatives (including fiber supplements)
- Cardiovascular (heart) disease
Show all 19Show 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
- Infrequent or excessive number of regular bowel movements
- Illicit drug use
- Vegetarians
- No fish oil supplements (including cod liver oil) for one month prior to study admission
- No dietary supplements, including those containing any vitamins, minerals, herbs, plant concentrates (including garlic, gingko, St. John's wort) or homeopathic remedies, for one month prior to study admission
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts Clinical and Translational Research Center
Boston, Massachusetts, 02111
About this study
Official title: Clinical Assessment of Barley and Oat Phytochemicals: Acute Bioavailability, Pharmacokinetics, and Bioactivity
The goal of this placebo-controlled, 3-way crossover study is to determine the acute (24-h) bioavailability and pharmacokinetics of the major phytochemicals found whole barley and oats, as well as their effects on selected measures of antioxidation, inflammation, insulin sensitivity/glucose regulation, and vascular remodeling following challenge by an oral glucose tolerance test (OGTT).
- Conditions
- Healthy
- Being tested
- Whole grain oats and barley
- Keywords
- oat, barley, whole grain, bioavailability, phytochemical
- Medical subject headings
- Gyrate Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole grain oats and barleyOther
One time dose of 48 g whole grain flour in 2 small muffins (24 g flour per muffin) per intervention
| Study group | Role | What they receive |
|---|---|---|
| Placebo muffin made with no whole grains | Placebo comparator | Not described Receives: Other: Whole grain oats and barley |
| Test muffin made with whole oats | Active comparator | Not described Receives: Other: Whole grain oats and barley |
| Test muffin made with whole barley | Active comparator | Not described Receives: Other: Whole grain oats and barley |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of phytochemicals and their in vivo metabolites in blood
Levels of phytochemicals and their in vivo metabolites in blood, urine, and feces following the consumption of whole grains delivered in a baked muffin
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startSep 2010
- Primary completionApr 2011
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Kellogg Company
- Responsible party
- Sponsor
- Investigators
- Jeffrey B Blumberg, PhD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303562
- Sponsor's protocol ID
- IRB 9571
- Status last verified
- May 2013
- First submitted
- 16 Nov 2010
- Last updated
- 27 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Barley and Oat Phytochemicals: Acute Bioavailability, Pharmacokinetics, and Bioactivity
- ClinicalTrials.gov ID
- NCT01303562
- Acronym / sponsor ID
- IRB 9571
- Conditions
- Healthy
- Keywords
- oat, barley, whole grain, bioavailability, phytochemical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Kellogg Company
- Study start
- Sep 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 24 Feb 2011 (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 goal of this placebo-controlled, 3-way crossover study is to determine the acute (24-h) bioavailability and pharmacokinetics of the major phytochemicals found whole barley and oats, as well as their effects on selected measures of antioxidation, inflammation, insulin sensitivity/glucose regulation, and vascular remodeling following challenge by an oral glucose tolerance test (OGTT).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo muffin made with no whole grains | Placebo comparator | Other: Whole grain oats and barley |
| Test muffin made with whole oats | Active comparator | Other: Whole grain oats and barley |
| Test muffin made with whole barley | Active comparator | Other: Whole grain oats and barley |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and postmenopausal women
- BMI 27-35.9 kg/m2
Key exclusion criteria (19 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 or laxatives (including fiber supplements)
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 |
|---|---|---|
| Whole grain oats and barleyOne time dose of 48 g whole grain flour in 2 small muffins (24 g flour per muffin) per intervention | Other | Placebo muffin made with no whole grains, Test muffin made with whole barley, Test muffin made with whole oats |
Primary outcome
Levels of phytochemicals and their in vivo metabolites in blood
Time frame: 24 hours
Levels of phytochemicals and their in vivo metabolites in blood, urine, and feces following the consumption of whole grains delivered in a baked muffin
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 27 May 2013.
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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.
Jeffrey B Blumberg, 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 Whole grain oats and barley in people with Healthy, 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 2 inclusion and 19 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 27 May 2013. 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?
Levels of phytochemicals and their in vivo metabolites in blood (time frame: 24 hours). 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 27 May 2013.