- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01190384
The Effect of Whole Beans on Inflammation and Satiety (BEAN)
July 6, 2017 updated by: University of California, Davis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Davis, California, United States, 95616
- Ragle Human Nutrition Research Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Men and Women 21 years old and older with metabolic syndrome
Exclusion Criteria:
- 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)
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bean Soup
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.
|
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.
Other Names:
|
Active Comparator: Couscous plus Fiber
Soup with added fiber; has a low ORAC value.
Subject serving is isocaloric to the experimental Bean soup.
|
Soup with added fiber to equal Bean soup.
Subjects' serving size is isocaloric to the experimental Bean soup.
Other Names:
|
Active Comparator: Couscous plus Grape Seed Extract
Control for ORAC value of the Bean soup; for examining the effect of fiber in the bean soup.
|
300 milligrams of grape seed extract in capsule form will be consumed with the low ORAC value soup.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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6 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satiety
Time Frame: 48 hours
|
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.
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48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Chulani T Kappagoda, M.D., Ph.D., University of California, Davis
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
August 25, 2010
First Submitted That Met QC Criteria
August 25, 2010
First Posted (Estimate)
August 27, 2010
Study Record Updates
Last Update Posted (Actual)
July 11, 2017
Last Update Submitted That Met QC Criteria
July 6, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201018072
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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