Clinical trial NCT01190384: The Effect of Whole Beans on Inflammation and Satiety
Official title: Bean Consumption: A Pilot Study in Overweight Men and Women on Immuno-metabolic and Food Intake Endpoints
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Metabolic Syndrome
Inflammation
Antioxidants
Satiety
Fiber
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Illinois Institute of Technology
First posted: 2010-08-27
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Inflammation
timeFrame: 6 hours
Secondary outcomes:
measure: Satiety
timeFrame: 48 hours
Other outcomes:
Locations:
city: Davis
country: United States
facility: Ragle Human Nutrition Research Center
state: California
Study officials:
affiliation: University of California, Davis
name: Chulani T Kappagoda, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.