The Effect of Eating Pulses for 8 Weeks on Satiety and Metabolic Syndrome Risk Factors in Overweight Individuals
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
2 other identifiers
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Feb 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2008
CompletedFirst Posted
Study publicly available on registry
January 30, 2008
CompletedStudy Start
First participant enrolled
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedJune 15, 2012
June 1, 2012
6 months
January 17, 2008
June 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
blood glucose, lipids and satiety hormones
4 months
Secondary Outcomes (1)
body weight, waist circumference and blood pressure
8 weeks
Study Arms (2)
Pulse group
EXPERIMENTALa group receiving a meal with pulses (5 cups/week) for 8 weeks
Energy-restricted group
EXPERIMENTALa group with a diet restriction of 500 kcal/day for 8 weeks
Interventions
Subjects in energy-restricted group will follow dietician advise to keep a conventional energy restriction diet.
Subjects in pulse group will consume the commercially available pulses for 8 weeks
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- smokers
- those on an energy restricted diet
- breakfast skippers
- pregnant/lactating women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Torontolead
- Mount Sinai Hospital, Canadacollaborator
Study Sites (1)
Leadership Sinai Centre for Diabetes, Mt. Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Harvey G. Anderson, Ph.D.
University of Toronto
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 17, 2008
First Posted
January 30, 2008
Study Start
February 1, 2008
Primary Completion
August 1, 2008
Study Completion
December 1, 2009
Last Updated
June 15, 2012
Record last verified: 2012-06