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

This study has been completed.
Sponsor:
Collaborator:
Mount Sinai Hospital, Canada
Information provided by (Responsible Party):
G. Harvey Anderson, University of Toronto
ClinicalTrials.gov Identifier:
NCT00604448
First received: January 17, 2008
Last updated: June 14, 2012
Last verified: June 2012

January 17, 2008
June 14, 2012
February 2008
August 2008   (final data collection date for primary outcome measure)
blood glucose, lipids and satiety hormones [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00604448 on ClinicalTrials.gov Archive Site
body weight, waist circumference and blood pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Obesity
  • Overweight
  • Other: Dietary advise
    Subjects in energy-restricted group will follow dietician advise to keep a conventional energy restriction diet.
    Other Name: Energy-restricted group
  • Other: Diet enriched with a meal containing pulses
    Subjects in pulse group will consume the commercially available pulses for 8 weeks
    Other Name: Pulse group
  • Experimental: Pulse group
    a group receiving a meal with pulses (5 cups/week) for 8 weeks
    Interventions:
    • Other: Dietary advise
    • Other: Diet enriched with a meal containing pulses
  • Experimental: Energy-restricted group
    a group with a diet restriction of 500 kcal/day for 8 weeks
    Interventions:
    • Other: Dietary advise
    • Other: Diet enriched with a meal containing pulses
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
December 2009
August 2008   (final data collection date for primary outcome measure)

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
Both
35 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00604448
Pulse_Canada_481556, UfT fund#: 481556
No
G. Harvey Anderson, University of Toronto
University of Toronto
Mount Sinai Hospital, Canada
Principal Investigator: Harvey G. Anderson, Ph.D. University of Toronto
University of Toronto
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP