The Effect of Whole Beans on Inflammation and Satiety

NCT01190384 | Completed

• 1 other identifier: 201018072
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

Metabolic Syndrome; Inflammation; Antioxidants; Satiety; Fiber

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Satiety

  48 hours

Study Arms (3)

Bean Soup

EXPERIMENTAL

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

Couscous plus Fiber

ACTIVE COMPARATOR

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

Other: Couscous plus fiber

Couscous plus Grape Seed Extract

ACTIVE COMPARATOR

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

Dietary Supplement: Grape seed extract

Interventions

Couscous plus fiber OTHER

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

Also known as: Non-active for antioxidants or fiber.

Couscous plus Fiber

Grape seed extract DIETARY_SUPPLEMENT

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

Also known as: Meganatural BP

Couscous plus Grape Seed Extract

Bean Soup 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.

Also known as: Whole black beans

Bean Soup

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and Women 21 years old and older with metabolic syndrome

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Davis: lead
• Illinois Institute of Technology: collaborator

Study Sites (1)

Ragle Human Nutrition Research Center

Davis, California, 95616, United States

Location

Related Publications (1)

• 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.

  PMID: 28735851 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Inflammation

Interventions

Dietary Fiber; Antioxidants; Grape Seed Extract

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Biological Factors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Protective Agents; Physiological Effects of Drugs; Specialty Uses of Chemicals; Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures; Pharmaceutical Preparations

Study Officials

• Chulani T Kappagoda, M.D., Ph.D.

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2010
• First Posted: August 27, 2010
• Study Start: August 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2014
• Last Updated: July 11, 2017

Record last verified: 2017-07

Locations

US (1)