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

  • United States
    • California
      • Davis, California, United States, 95616
        • Ragle Human Nutrition Research Center

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:

  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.

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.
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 Names:
  • 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 Names:
  • 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 Names:
  • Meganatural BP

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.
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.
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

Illinois Institute of Technology

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.

General Publications

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

Keywords

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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