Metabolic SyndromeBEANNCT01190384
The Effect of Whole Beans on Inflammation and Satiety
A study testing Couscous plus fiber, Grape seed extract and Bean Soup in people with Metabolic Syndrome, run by University of California, Davis at 1 site in United States.
Trial summary
Determine whether eating beans with a high fat meal will reduce the inflammatory response in people with the metabolic syndrome and increase feelings of satiety. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Couscous plus fiber, Grape seed extract and Bean Soup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Apr 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and Women 21 years old and older with metabolic syndrome
Who cannot join
- Smokers
- Female subjects who are pregnant or lactating
- Subjects taking any medications that would interfere with outcomes of the study i.e. lipid lowering medications, anti-inflammatory drugs (i.e. ibuprofen), dietary supplements
- Subjects with any known allergy or intolerance to foods involved in the study(cantaloupe, egg, dairy, wheat, beans, couscous, grape seed extract)
- Subjects who are actively trying to lose weight
- Subjects with unusual dietary habits (i.e. pica, anorexia nervosa, extreme food restriction, binging and/or purging disorders)
Show all 9Show fewer
- Subjects who are addicted to drugs or alcohol or who are <1 year recovery program
- Subjects who present with significant psychiatric or neurological disturbances as determined by the primary investigator (i.e. uncontrolled bipolar disorder) These subjects will be referred to their primary care doctor for further care.
- Subjects with documented atherosclerotic disease, inflammatory disease, diabetes mellitus (fasting blood sugar ≥126 mg/dl), uncontrolled hypertension (≥ 140/90mmHg), liver and kidney disease as identified by routine blood tests (chemistry panels). These subjects will be referred to their primary care doctor for further care.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ragle Human Nutrition Research Center
Davis, California, 95616
About this study
Official title: Bean Consumption: A Pilot Study in Overweight Men and Women on Immuno-metabolic and Food Intake Endpoints
Determine whether eating beans with a high fat meal will reduce the inflammatory response in people with the metabolic syndrome and increase feelings of satiety.
Read the detailed description
Determine whether eating beans with a high fat meal will reduce the inflammatory response in people with the metabolic syndrome; thereby possibly postponing the diagnosis of diabetes or other chronic inflammatory diseases. These researchers are also interested in how consuming beans can affect the length of time a person stays full after a meal.
- Conditions
- Metabolic Syndrome
- Being tested
- Couscous plus fiber, Grape seed extract, Bean Soup
- Keywords
- Metabolic Syndrome, Inflammation, Antioxidants, Satiety, Fiber
- Medical subject headings
- Metabolic Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couscous plus fiberOther
Also called Non-active for antioxidants or fiber.
Soup with added fiber to equal Bean soup. Subjects' serving size is isocaloric to the experimental Bean soup.
Grape seed extractDietary supplement
Also called Meganatural BP
300 milligrams of grape seed extract in capsule form will be consumed with the low ORAC value soup.
Bean SoupOther
Also called Whole black beans
Experimental soup with a high fiber content and ORAC value. The ORAC value is the Oxygen Radical Absorbance Capacity (ORAC) score which is a measure of the antioxidant levels of food and is expressed as Trolox Equivalents. The antioxidants in the soup are derived from beans.
| Study group | Role | What they receive |
|---|---|---|
| Bean Soup | Experimental | Experimental soup with a high fiber content and ORAC value. The ORAC value is the Oxygen Radical Absorbance Capacity (ORAC) score which is a measure of the antioxidant levels of food and is expressed as Trolox Equivalents. The antioxidants in the soup are derived from beans. Receives: Other: Bean Soup |
| Couscous plus Fiber | Active comparator | Soup with added fiber; has a low ORAC value. Subject serving is isocaloric to the experimental Bean soup. Receives: Other: Couscous plus fiber |
| Couscous plus Grape Seed Extract | Active comparator | Control for ORAC value of the Bean soup; for examining the effect of fiber in the bean soup. Receives: Dietary Supplement: Grape seed extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammation
Measuring inflammatory markers after consumption of a high fat meal in conjunction with one of three soups. The three soups are: a bean soup high in fiber and antioxidants, a couscous soup high in fiber, and a couscous soup high in antioxidants.
Measured: 6 hours
Secondary outcomes (1)
Satiety
Measure subjects' perception of fullness during the 6 hour post-prandial testing period. Subjects will keep food records on the study day and day following to look for any longer effects on satiety as measured by food intake.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionApr 2012
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Illinois Institute of Technology
- Responsible party
- Sponsor
- Investigators
- Chulani T Kappagoda, M.D., Ph.D., Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01190384
- Sponsor's protocol ID
- 201018072
- Acronym
- BEAN
- Status last verified
- Jul 2017
- First submitted
- 25 Aug 2010
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Reverri EJ, Randolph JM, Kappagoda CT, Park E, Edirisinghe I, Burton-Freeman BM. Assessing beans as a source of intrinsic fiber on satiety in men and women with metabolic syndrome. Appetite. 2017 Nov 1;118:75-81. doi: 10.1016/j.appet.2017.07.013. Epub 2017 Jul 20.
PubMed 28735851
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bean Consumption: A Pilot Study in Overweight Men and Women on Immuno-metabolic and Food Intake Endpoints
- ClinicalTrials.gov ID
- NCT01190384
- Acronym / sponsor ID
- BEAN / 201018072
- Conditions
- Metabolic Syndrome
- Keywords
- Metabolic Syndrome, Inflammation, Antioxidants, Satiety, Fiber
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Illinois Institute of Technology
- Study start
- Aug 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 27 Aug 2010 (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.
Determine whether eating beans with a high fat meal will reduce the inflammatory response in people with the metabolic syndrome and increase feelings of satiety.
Detailed description
Determine whether eating beans with a high fat meal will reduce the inflammatory response in people with the metabolic syndrome; thereby possibly postponing the diagnosis of diabetes or other chronic inflammatory diseases. These researchers are also interested in how consuming beans can affect the length of time a person stays full after a meal.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bean Soup | Experimental | Other: Bean SoupExperimental soup with a high fiber content and ORAC value. The ORAC value is the Oxygen Radical Absorbance Capacity (ORAC) score which is a measure of the antioxidant levels of food and is expressed as Trolox Equivalents. The antioxidants in the soup are derived from beans. |
| Couscous plus Fiber | Active comparator | Other: Couscous plus fiberSoup with added fiber; has a low ORAC value. Subject serving is isocaloric to the experimental Bean soup. |
| Couscous plus Grape Seed Extract | Active comparator | Dietary Supplement: Grape seed extractControl for ORAC value of the Bean soup; for examining the effect of fiber in the bean soup. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and Women 21 years old and older with metabolic syndrome
Key exclusion criteria (9 listed)
- Smokers
- Female subjects who are pregnant or lactating
- Subjects taking any medications that would interfere with outcomes of the study i.e. lipid lowering medications, anti-inflammatory drugs (i.e. ibuprofen), dietary supplements
- Subjects with any known allergy or intolerance to foods involved in the study(cantaloupe, egg, dairy, wheat, beans, couscous, grape seed extract)
- Subjects who are actively trying to lose weight
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 |
|---|---|---|
| Couscous plus fiberAlso: Non-active for antioxidants or fiber.Soup with added fiber to equal Bean soup. Subjects' serving size is isocaloric to the experimental Bean soup. | Other | Couscous plus Fiber |
| Grape seed extractAlso: Meganatural BP300 milligrams of grape seed extract in capsule form will be consumed with the low ORAC value soup. | Dietary supplement | Couscous plus Grape Seed Extract |
| Bean SoupAlso: Whole black beansExperimental soup with a high fiber content and ORAC value. The ORAC value is the Oxygen Radical Absorbance Capacity (ORAC) score which is a measure of the antioxidant levels of food and is expressed as Trolox Equivalents. The antioxidants in the soup are derived from beans. | Other | Bean Soup |
Primary outcome
Inflammation
Time frame: 6 hours
Measuring inflammatory markers after consumption of a high fat meal in conjunction with one of three soups. The three soups are: a bean soup high in fiber and antioxidants, a couscous soup high in fiber, and a couscous soup high in antioxidants.
1 secondary outcome
Satiety
Time frame: 48 hours
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 11 Jul 2017.
- Derived from this study: PubMed 28735851Reverri EJ, Randolph JM, Kappagoda CT, Park E, Edirisinghe I, Burton-Freeman BM. Assessing beans as a source of intrinsic fiber on satiety in men and women with metabolic syndrome. Appetite. 2017 Nov 1;118:75-81. doi: 10.1016/j.appet.2017.07.013. Epub 2017 Jul 20.
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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.
Chulani T Kappagoda, M.D., Ph.D. principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Couscous plus fiber, Grape seed extract and Bean Soup in people with Metabolic Syndrome, run by University of California, Davis 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 1 inclusion and 9 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 11 Jul 2017. 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. 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?
Inflammation (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01190384, which also lists 1 linked publication.
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 11 Jul 2017.