Overview

This trial is active, not recruiting.

Condition metabolic syndrome
Treatments couscous plus fiber, grape seed extract, whole beans
Sponsor University of California, Davis
Start date August 2010
End date April 2012
Trial size 12 participants
Trial identifier NCT01190384, 201018072

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (subject)
Primary purpose basic science
Arm
(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.
whole beans Whole beans
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.
(Active Comparator)
Soup with added fiber; has a low ORAC value. Subject serving is isocaloric to the experimental Bean soup.
couscous plus fiber Non-active for antioxidants or fiber.
Soup with added fiber to equal Bean soup. Subjects' serving size is isocaloric to the experimental Bean soup.
(Active Comparator)
Control for ORAC value of the Bean soup; for examining the effect of fiber in the bean soup.
grape seed extract Meganatural BP
300 milligrams of grape seed extract in capsule form will be consumed with the low ORAC value soup.

Primary Outcomes

Measure
Inflammation
time frame: 6 hours

Secondary Outcomes

Measure
Satiety
time frame: 48 hours

Eligibility Criteria

Male or female participants at least 21 years old.

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.

Additional Information

Official title Bean Consumption: A Pilot Study in Overweight Men and Women on Immuno-metabolic and Food Intake Endpoints
Principal investigator Chulani T Kappagoda, M.D., Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by University of California, Davis.