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The Effect of Eating Pulses for 8 Weeks on Satiety and Metabolic Syndrome Risk Factors in Overweight Individuals

Primary Purpose

Obesity, Overweight

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dietary advise
Diet enriched with a meal containing pulses
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring pulses, beans, obesity, overweight, metabolic syndrome

Eligibility Criteria

35 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • overweight/obese adults
  • body mass index: 27-35 kg/m2
  • individuals not prescribed medications over the past 6 months that could interfere with the study outcomes (i.e. statins or metformin)

Exclusion Criteria:

  • smokers
  • those on an energy restricted diet
  • breakfast skippers
  • pregnant/lactating women

Sites / Locations

  • Leadership Sinai Centre for Diabetes, Mt. Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Pulse group

Energy-restricted group

Arm Description

a group receiving a meal with pulses (5 cups/week) for 8 weeks

a group with a diet restriction of 500 kcal/day for 8 weeks

Outcomes

Primary Outcome Measures

blood glucose, lipids and satiety hormones

Secondary Outcome Measures

body weight, waist circumference and blood pressure

Full Information

First Posted
January 17, 2008
Last Updated
June 14, 2012
Sponsor
University of Toronto
Collaborators
Mount Sinai Hospital, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT00604448
Brief Title
The Effect of Eating Pulses for 8 Weeks on Satiety and Metabolic Syndrome Risk Factors in Overweight Individuals
Official Title
The Effect of Frequent Consumption of Pulses for Eight Weeks on Blood Lipids and on Glycemic and Satiety Hormones Response in Overweight and Obese Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
August 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
Mount Sinai Hospital, Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In 2004, almost 60% of adult Canadians were overweight or obese. This is a serious health concern due to the burden of common health risks associated with being overweight and obese, including increased blood sugar, blood lipids and blood pressure. Together these risks are known as metabolic syndrome. Obesity, the most common nutrition problem in Canada, can in many cases be treated through changes in our diet (what we eat and/or how much we eat). Pulses (beans, chickpeas, lentils and peas) when eaten on a regular basis may result in decreased health risks associated with being overweight and obese. The purpose of this study is to find out whether eating pulses (5 cups per week) results in improvements in metabolic syndrome risk factors. We also want to determine whether the consumption of pulses alters the levels of satiety hormones (hormones that make us feel hungry or full) in the blood. This study will have 50 participants.
Detailed Description
The primary objective of this study is to compare the effect of consuming 5 cups per week of commercially available pulses on body weight, satiety and metabolic syndrome risk factors in overweight/obese adults over 8 weeks with a conventional energy restriction diet. The amount of pulses to be included in the study protocol is based on the USDA Dietary Guideline of 3 cups of pulses per week, but is somewhat high at 5 cups/week. Both groups will receive counseling from a registered dietitian. Pulses will be provided free of charge, delivered weekly to each participant and instructions will be given on their preparation. Subjects will be asked to complete a pulse log to record the date and time of day the pulses are consumed, as well as the type of pulse and other foods consumed during the pulse meal. Cooked pulses will be provided in canned or frozen forms. After completing the meal, subjects will be asked to fill out information (ID, date and time) on the sealed sticker attached to each can or inserted into the frozen pulses portion. In order to measure compliance, subjects will be asked to return all stickers at the end of the week, when new foods are provided to them. For those in the energy restriction group, the dietitian will a have a defined amount of time to advise on how to reduce caloric intake by 500 kcal per day at week 1 (the start of the study) and week 4 (halfway through the study). In addition, the dietitian will obtain a food history and ask additional pulse consumption questions at week 1 and week 8. Also, a 24 h food recall will be obtained from subjects by a dietitian at weeks 1, 4 and 8. For all subjects, body weight, waist girth, blood pressure, fasting blood lipids, glucose, insulin and satiety hormones will be measured at weeks 1, 4 and 8. Each subject will arrive at the same chosen time for each session, between 8:00 and 10:00 a.m. Upon arrival, subjects will fill out a Sleep Habits and Stress Factors Questionnaire and a Food Intake and Activity Questionnaire. For each session, subjects will be asked to arrive after an overnight fast; only water will be allowed until 1 hour before blood collection. Blood glucose and insulin response to a glucose load (75 g) will be determined at weeks 1 and 8. For this test (an oral glucose tolerance test), an indwelling catheter will be inserted in the antecubital vein by a nurse and blood samples will be taken at prior to (-15 minutes) and at 0, 10, 20, 30, 60, 90 and 120 minutes after the consumption of a 75 g glucose drink. A total of 90 ml of blood will be sampled at weeks 1 and 8. A single fasting blood sample (20 ml of blood) will also be obtained at week 4 for the same analysis. The week 1 and week 8 sessions will last a maximum of 4 hours and the week 4 session will last a maximum of 2 hours. Blood samples will be analyzed for glucose, insulin, leptin, ghrelin, glucagon-like peptide-1 (GLP-1), low-density lipoprotein (LDL), triglyceride (TG), C-reactive protein, C-peptide, adiponectin and glycosylated hemoglobin (HbA1c). Pulses will be obtained from Can Grow Foods, Heinz or purchased from the supermarket.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
pulses, beans, obesity, overweight, metabolic syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulse group
Arm Type
Experimental
Arm Description
a group receiving a meal with pulses (5 cups/week) for 8 weeks
Arm Title
Energy-restricted group
Arm Type
Experimental
Arm Description
a group with a diet restriction of 500 kcal/day for 8 weeks
Intervention Type
Other
Intervention Name(s)
Dietary advise
Other Intervention Name(s)
Energy-restricted group
Intervention Description
Subjects in energy-restricted group will follow dietician advise to keep a conventional energy restriction diet.
Intervention Type
Other
Intervention Name(s)
Diet enriched with a meal containing pulses
Other Intervention Name(s)
Pulse group
Intervention Description
Subjects in pulse group will consume the commercially available pulses for 8 weeks
Primary Outcome Measure Information:
Title
blood glucose, lipids and satiety hormones
Time Frame
4 months
Secondary Outcome Measure Information:
Title
body weight, waist circumference and blood pressure
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: overweight/obese adults body mass index: 27-35 kg/m2 individuals not prescribed medications over the past 6 months that could interfere with the study outcomes (i.e. statins or metformin) Exclusion Criteria: smokers those on an energy restricted diet breakfast skippers pregnant/lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harvey G. Anderson, Ph.D.
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leadership Sinai Centre for Diabetes, Mt. Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada

12. IPD Sharing Statement

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The Effect of Eating Pulses for 8 Weeks on Satiety and Metabolic Syndrome Risk Factors in Overweight Individuals

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