The Effect of Whole Beans on Inflammation and Satiety

NCT ID: NCT01190384

Last Updated: 2017-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2014-04-30

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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Bean Soup

Intervention Type: OTHER

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.

Couscous plus Fiber

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

Group Type: ACTIVE_COMPARATOR

Couscous plus fiber

Intervention Type: OTHER

Soup with added fiber to equal Bean soup. Subjects' serving size is isocaloric to the experimental Bean soup.

Couscous plus Grape Seed Extract

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

Group Type: ACTIVE_COMPARATOR

Grape seed extract

Intervention Type: DIETARY_SUPPLEMENT

300 milligrams of grape seed extract in capsule form will be consumed with the low ORAC value soup.

Interventions

Couscous plus fiber

Soup with added fiber to equal Bean soup. Subjects' serving size is isocaloric to the experimental Bean soup.

Intervention Type: OTHER

Grape seed extract

300 milligrams of grape seed extract in capsule form will be consumed with the low ORAC value soup.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: OTHER

Other Intervention Names

Non-active for antioxidants or fiber.; Meganatural BP; Whole black beans

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Illinois Institute of Technology

OTHER

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chulani T Kappagoda, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

Ragle Human Nutrition Research Center

Davis, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28735851 (View on PubMed)

Other Identifiers

201018072

Identifier Type: -

Identifier Source: org_study_id