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Effect of Consuming Beans for One Month on Blood Lipids, Satiety, Intake Regulation and Body Weight

Primary Purpose

Overweight, Obesity, Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
navy beans added to regular diet
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring beans, pulses, satiety, appetite, obesity, overweight, diabetes, metabolic syndrome, hypertension, blood glucose, insulin, cholesterol, HDL, LDL, leptin, GLP-1, adiponectin, Peptide YY, diet

Eligibility Criteria

35 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • BMI 27-40 kg/m2

Exclusion Criteria:

  • smokers and individuals who have prescribed medications over the past 6 months that could interfere with the study outcomes (i.e. statins, metformin). Breakfast skippers, those on a restricted energy diet or pregnant/lactating women

Sites / Locations

  • Department of Nutritional Sciences, University of Toronto

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bean group

Arm Description

A group consuming 5 cups/week of navy beans for a month

Outcomes

Primary Outcome Measures

body weight, waist circumference, blood glucose, satiety hormones, and blood lipids, inflammation factor, and glycated haemoglobin

Secondary Outcome Measures

Full Information

First Posted
August 25, 2008
Last Updated
June 14, 2012
Sponsor
University of Toronto
Collaborators
Ontario Ministry of Agriculture, Food and Rural Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00741923
Brief Title
Effect of Consuming Beans for One Month on Blood Lipids, Satiety, Intake Regulation and Body Weight
Official Title
Beans and Potatoes in the Regulation of Food Intake and Risk Factors for Chronic Diseases. Effect of Consuming Beans for One Month on Blood Lipids, Satiety, Intake Regulation and Body Weight
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto
Collaborators
Ontario Ministry of Agriculture, Food and Rural Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This project investigates the effect of regular consumption of commercially available processed white beans (5 cups per week) on food intake, body weight, blood pressure, satiety hormones and glycemic response over a 4-week period. We have chosen to provide participants with canned white beans, the most accessible and frequently consumed bean in North America. They are inexpensive, a good source of high quality nutrients and ready to eat. Based upon published literature and short-term studies conducted in our laboratory, we hypothesize that regular consumption of commercially available canned beans will increase satiety and improve the control of food intake, body weight, blood glucose and blood lipids.
Detailed Description
The metabolic syndrome is a clustering of chronic disease risk factors, including abdominal obesity, dyslipidemia, elevated blood pressure and elevated fasting blood glucose. A main treatment for metabolic syndrome is lifestyle modification (alterations in diet and/or physical activity patterns) resulting in weight loss. Beans are easily incorporated into the diet and may lead to the attainment and maintenance of healthy a body weight and improved metabolic control. Canned baked navy beans (with tomato sauce) have a low glycemic response following consumption, however, whether this effect has long-term benefits on glycemic control requires further investigation. OBJECTIVE To determine the effect of consuming 5 cups per week of commercially available canned navy beans over 4 weeks on risk factors associated with the metabolic syndrome. Subjects Inclusion criteria: Men and women (n=16) between 35 and 55 years of age with a body mass index (BMI) of 27 to 40 kg/m2. Exclusion criteria: smoking or any major surgery/medical condition within the last 6 months, use of medications that could interfere with the study outcomes, gastrointestinal, liver or kidney disease and women who were pregnant/lactating

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity, Metabolic Syndrome, Diabetes, Hypertension
Keywords
beans, pulses, satiety, appetite, obesity, overweight, diabetes, metabolic syndrome, hypertension, blood glucose, insulin, cholesterol, HDL, LDL, leptin, GLP-1, adiponectin, Peptide YY, diet

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bean group
Arm Type
Experimental
Arm Description
A group consuming 5 cups/week of navy beans for a month
Intervention Type
Other
Intervention Name(s)
navy beans added to regular diet
Other Intervention Name(s)
Heinz beans
Intervention Description
5 cups per week of commercially available white beans for 4-weeks
Primary Outcome Measure Information:
Title
body weight, waist circumference, blood glucose, satiety hormones, and blood lipids, inflammation factor, and glycated haemoglobin
Time Frame
at the beginning and at the end of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BMI 27-40 kg/m2 Exclusion Criteria: smokers and individuals who have prescribed medications over the past 6 months that could interfere with the study outcomes (i.e. statins, metformin). Breakfast skippers, those on a restricted energy diet or pregnant/lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harvey Anderson, Ph.D.
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nutritional Sciences, University of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 3E2
Country
Canada

12. IPD Sharing Statement

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Effect of Consuming Beans for One Month on Blood Lipids, Satiety, Intake Regulation and Body Weight

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