The Effect of Whole Beans on Inflammation and Satiety

Metabolic Syndrome Clinical Trial

— BEAN  

Official title:

Bean Consumption: A Pilot Study in Overweight Men and Women on Immuno-metabolic and Food Intake Endpoints

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01190384
• Other study ID #: 201018072
• Status: Completed
• Phase: N/A
• First received: August 25, 2010
• Last updated: July 6, 2017
• Start date: August 2010
• Est. completion date: April 2014

Study information

• Verified date: July 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2014
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Other:
• Couscous plus fiber
Soup with added fiber to equal Bean soup. Subjects' serving size is isocaloric to the experimental 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:
• 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.

Locations

Country	Name	City	State
United States	Ragle Human Nutrition Research Center	Davis	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	Illinois Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 hours
Secondary	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.	48 hours