The Effect of Whole Beans on Inflammation and Satiety

Study Overview
=================
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.

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

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Other: Couscous plus fiber
* Dietary Supplement: Grape seed extract
* Other: Bean Soup


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bean Soup<br>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<br>* 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.<br>* Other names: Whole black beans;|
| Active Comparator: Couscous plus Fiber<br>Soup with added fiber; has a low ORAC value. Subject serving is isocaloric to the experimental Bean soup. | Other: Couscous plus fiber<br>* Soup with added fiber to equal Bean soup. Subjects' serving size is isocaloric to the experimental Bean soup.<br>* Other names: Non-active for antioxidants or fiber.;|
| Active Comparator: Couscous plus Grape Seed Extract<br>Control for ORAC value of the Bean soup; for examining the effect of fiber in the bean soup. | Dietary Supplement: Grape seed extract<br>* 300 milligrams of grape seed extract in capsule form will be consumed with the low ORAC value soup.<br>* Other names: Meganatural BP;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metabolic Syndrome, Inflammation, Antioxidants, Satiety, Fiber