search
Back to results

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

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Couscous plus fiber
Grape seed extract
Bean Soup
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metabolic Syndrome focused on measuring Metabolic Syndrome, Inflammation, Antioxidants, Satiety, Fiber

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ragle Human Nutrition Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Bean Soup

Couscous plus Fiber

Couscous plus Grape Seed Extract

Arm Description

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.

Soup with added fiber; has a low ORAC value. Subject serving is isocaloric to the experimental Bean soup.

Control for ORAC value of the Bean soup; for examining the effect of fiber in the bean soup.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 25, 2010
Last Updated
July 6, 2017
Sponsor
University of California, Davis
Collaborators
Illinois Institute of Technology
search

1. Study Identification

Unique Protocol Identification Number
NCT01190384
Brief Title
The Effect of Whole Beans on Inflammation and Satiety
Acronym
BEAN
Official Title
Bean Consumption: A Pilot Study in Overweight Men and Women on Immuno-metabolic and Food Intake Endpoints
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
Illinois Institute of Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Metabolic Syndrome, Inflammation, Antioxidants, Satiety, Fiber

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bean Soup
Arm Type
Experimental
Arm Description
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.
Arm Title
Couscous plus Fiber
Arm Type
Active Comparator
Arm Description
Soup with added fiber; has a low ORAC value. Subject serving is isocaloric to the experimental Bean soup.
Arm Title
Couscous plus Grape Seed Extract
Arm Type
Active Comparator
Arm Description
Control for ORAC value of the Bean soup; for examining the effect of fiber in the bean soup.
Intervention Type
Other
Intervention Name(s)
Couscous plus fiber
Other Intervention Name(s)
Non-active for antioxidants or fiber.
Intervention Description
Soup with added fiber to equal Bean soup. Subjects' serving size is isocaloric to the experimental Bean soup.
Intervention Type
Dietary Supplement
Intervention Name(s)
Grape seed extract
Other Intervention Name(s)
Meganatural BP
Intervention Description
300 milligrams of grape seed extract in capsule form will be consumed with the low ORAC value soup.
Intervention Type
Other
Intervention Name(s)
Bean Soup
Other Intervention Name(s)
Whole black beans
Intervention Description
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.
Primary Outcome Measure Information:
Title
Inflammation
Description
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.
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Satiety
Description
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.
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chulani T Kappagoda, M.D., Ph.D.
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ragle Human Nutrition Research Center
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28735851
Citation
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.
Results Reference
derived

Learn more about this trial

The Effect of Whole Beans on Inflammation and Satiety

We'll reach out to this number within 24 hrs