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The Effect of Whole Beans on Inflammation and Satiety (BEAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01190384
Recruitment Status : Completed
First Posted : August 27, 2010
Last Update Posted : July 11, 2017
Sponsor:
Collaborator:
Illinois Institute of Technology
Information provided by (Responsible Party):
University of California, Davis

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Other: Couscous plus fiber Dietary Supplement: Grape seed extract Other: Bean Soup Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Bean Consumption: A Pilot Study in Overweight Men and Women on Immuno-metabolic and Food Intake Endpoints
Study Start Date : August 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 Other: 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.
Other Name: Whole black beans
Active Comparator: Couscous plus Fiber
Soup with added fiber; has a low ORAC value. Subject serving is isocaloric to the experimental Bean soup.
 Other: Couscous plus fiber
Soup with added fiber to equal Bean soup. Subjects' serving size is isocaloric to the experimental Bean soup.
Other Name: Non-active for antioxidants or fiber.
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.
 Dietary Supplement: Grape seed extract
300 milligrams of grape seed extract in capsule form will be consumed with the low ORAC value soup.
Other Name: Meganatural BP


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Men and Women 21 years old and older with metabolic syndrome

Exclusion Criteria:

  1. Smokers
  2. Female subjects who are pregnant or lactating
  3. 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
  4. Subjects with any known allergy or intolerance to foods involved in the study(cantaloupe, egg, dairy, wheat, beans, couscous, grape seed extract)
  5. Subjects who are actively trying to lose weight
  6. Subjects with unusual dietary habits (i.e. pica, anorexia nervosa, extreme food restriction, binging and/or purging disorders)
  7. Subjects who are addicted to drugs or alcohol or who are <1 year recovery program
  8. 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.
  9. 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01190384


Locations
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United States, California
Ragle Human Nutrition Research Center
Davis, California, United States, 95616
Sponsors and Collaborators
University of California, Davis
Illinois Institute of Technology
Investigators
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Principal Investigator: Chulani T Kappagoda, M.D., Ph.D. University of California, Davis
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01190384    
Other Study ID Numbers: 201018072
First Posted: August 27, 2010    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017
Keywords provided by University of California, Davis:
Metabolic Syndrome
Inflammation
Antioxidants
Satiety
Fiber
Additional relevant MeSH terms:
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Grape Seed Extract
Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
 Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Antineoplastic Agents