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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by University of California, Davis.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01190384
First received: August 25, 2010
Last updated: May 8, 2012
Last verified: May 2012
  Purpose

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 Intervention
Metabolic Syndrome
Other: Couscous plus fiber
Dietary Supplement: Grape seed extract
Other: Whole beans

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Bean Consumption: A Pilot Study in Overweight Men and Women on Immuno-metabolic and Food Intake Endpoints

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Inflammation [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    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:
  • Satiety [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    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.


Enrollment: 12
Study Start Date: August 2010
Estimated Study Completion Date: August 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Whole 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 Name: Whole 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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01190384

Locations
United States, California
Ragle Human Nutrition Research Center
Davis, California, United States, 95616
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Chulani T Kappagoda, M.D., Ph.D. University of California, Davis
  More Information

No publications provided

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01190384     History of Changes
Other Study ID Numbers: 201018072
Study First Received: August 25, 2010
Last Updated: May 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Metabolic Syndrome
Inflammation
Antioxidants
Satiety
Fiber

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Antioxidants
Grape Seed Extract
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014