NCT00604448

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 30, 2008

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 15, 2012

Status Verified

June 1, 2012

Enrollment Period

6 months

First QC Date

January 17, 2008

Last Update Submit

June 14, 2012

Conditions

Keywords

pulsesbeansobesityoverweightmetabolic syndrome

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

EXPERIMENTAL

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

Other: Dietary adviseOther: Diet enriched with a meal containing pulses

Energy-restricted group

EXPERIMENTAL

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

Other: Dietary adviseOther: Diet enriched with a meal containing pulses

Interventions

Subjects in energy-restricted group will follow dietician advise to keep a conventional energy restriction diet.

Also known as: Energy-restricted group
Energy-restricted groupPulse group

Subjects in pulse group will consume the commercially available pulses for 8 weeks

Also known as: Pulse group
Energy-restricted groupPulse group

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Study Sites (1)

Leadership Sinai Centre for Diabetes, Mt. Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Conditions

ObesityOverweightMetabolic Syndrome

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Harvey G. Anderson, Ph.D.

    University of Toronto

    PRINCIPAL INVESTIGATOR

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

Locations