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Pulses, Satiation, Food Intake and Blood Glucose

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
dietary treatment
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome

Eligibility Criteria

20 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy young males with BMI of 20-24.9 kg/m2

Exclusion Criteria:

  • Females
  • Smokers
  • Breakfast skippers
  • Individuals with diabetes or other metabolic diseases
  • Those scoring ≥ 11 on an Eating Habit Questionnaire

Sites / Locations

  • Department of Nutritional Sciences, University of Toronto

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Pasta, tomato sauce & added chickpeas

Pasta, tomato sauce and added lentils

Pasta, tomato sauce and added navy beans

Pasta, tomato sauce with yellow peas

Pasta and tomato sauce

Arm Description

The pulse treatments and control (pasta with tomato sauce) were made the day before the session and the recipe was calculated to provide 1500 kcal at each session. All meals had the same energy density (~77kcal/100g). Calories derived from pulses were consistent among all pulse treatments (44%). The pulse treatments and control all contained macaroni pasta and homemade tomato sauce.

The pulse treatments and control (pasta with tomato sauce) were made the day before the session and the recipe was calculated to provide 1500 kcal at each session. All meals had the same energy density (~77kcal/100g). Calories derived from pulses were consistent among all pulse treatments (44%). The pulse treatments and control all contained macaroni pasta and homemade tomato sauce.

The pulse treatments and control (pasta with tomato sauce) were made the day before the session and the recipe was calculated to provide 1500 kcal at each session. All meals had the same energy density (~77kcal/100g). Calories derived from pulses were consistent among all pulse treatments (44%). The pulse treatments and control all contained macaroni pasta and homemade tomato sauce.

The pulse treatments and control (pasta with tomato sauce) were made the day before the session and the recipe was calculated to provide 1500 kcal at each session. All meals had the same energy density (~77kcal/100g). Calories derived from pulses were consistent among all pulse treatments (44%). The pulse treatments and control all contained macaroni pasta and homemade tomato sauce.

The pulse treatments and control (pasta with tomato sauce) were made the day before the session and the recipe was calculated to provide 1500 kcal at each session. All meals had the same energy density (~77kcal/100g). Calories derived from pulses were consistent among all pulse treatments (44%). The pulse treatments and control all contained macaroni pasta and homemade tomato sauce.

Outcomes

Primary Outcome Measures

Short-term energy intake
Energy intake was measured at the treatment meal (0-20 min) and at a pizza meal (second meal) provided four hours later (260-280 min).

Secondary Outcome Measures

Blood glucose and satiety
Following treatment meal consumption, blood glucose and appetite were measured at 20, 40, 60, 110, 140, 200 and 260 min and are reported as pre-second meal values. Following the pizza meal, blood glucose and appetite were measured at 280, 300, 320 and 340 min and are reported as post-second meal values.

Full Information

First Posted
July 27, 2011
Last Updated
August 3, 2011
Sponsor
University of Toronto
Collaborators
Agriculture and Agri-Food Canada
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1. Study Identification

Unique Protocol Identification Number
NCT01410851
Brief Title
Pulses, Satiation, Food Intake and Blood Glucose
Official Title
The Acute Effects of Pulse Consumption on Glycaemic Responses and Measures of Satiety and Satiation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Toronto
Collaborators
Agriculture and Agri-Food Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Pulses have the potential to be positioned as a food for body weight and metabolic control based on their composition, effects on rate of digestion and absorption of fat and carbohydrates, and effects on satiety. However, the role of individual pulses incorporated into a mixed meal on regulation of food intake, satiety and glycaemic control remains unclear. Therefore, the objective of our study was to determine the effects of ad libitum consumption of pulse meals (treatments) on food intake at an ad libitum pulse meal, food intake at an ad libitum pizza meal at four hours, subjective appetite and blood glucose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pasta, tomato sauce & added chickpeas
Arm Type
Experimental
Arm Description
The pulse treatments and control (pasta with tomato sauce) were made the day before the session and the recipe was calculated to provide 1500 kcal at each session. All meals had the same energy density (~77kcal/100g). Calories derived from pulses were consistent among all pulse treatments (44%). The pulse treatments and control all contained macaroni pasta and homemade tomato sauce.
Arm Title
Pasta, tomato sauce and added lentils
Arm Type
Experimental
Arm Description
The pulse treatments and control (pasta with tomato sauce) were made the day before the session and the recipe was calculated to provide 1500 kcal at each session. All meals had the same energy density (~77kcal/100g). Calories derived from pulses were consistent among all pulse treatments (44%). The pulse treatments and control all contained macaroni pasta and homemade tomato sauce.
Arm Title
Pasta, tomato sauce and added navy beans
Arm Type
Experimental
Arm Description
The pulse treatments and control (pasta with tomato sauce) were made the day before the session and the recipe was calculated to provide 1500 kcal at each session. All meals had the same energy density (~77kcal/100g). Calories derived from pulses were consistent among all pulse treatments (44%). The pulse treatments and control all contained macaroni pasta and homemade tomato sauce.
Arm Title
Pasta, tomato sauce with yellow peas
Arm Type
Experimental
Arm Description
The pulse treatments and control (pasta with tomato sauce) were made the day before the session and the recipe was calculated to provide 1500 kcal at each session. All meals had the same energy density (~77kcal/100g). Calories derived from pulses were consistent among all pulse treatments (44%). The pulse treatments and control all contained macaroni pasta and homemade tomato sauce.
Arm Title
Pasta and tomato sauce
Arm Type
Experimental
Arm Description
The pulse treatments and control (pasta with tomato sauce) were made the day before the session and the recipe was calculated to provide 1500 kcal at each session. All meals had the same energy density (~77kcal/100g). Calories derived from pulses were consistent among all pulse treatments (44%). The pulse treatments and control all contained macaroni pasta and homemade tomato sauce.
Intervention Type
Other
Intervention Name(s)
dietary treatment
Intervention Description
A within-subject, balanced repeated-measures design was followed where subjects received 4 treatments or control over 5 weeks approximately 1 week apart. The pulse treatments contained: (1) chickpeas (Primo, Toronto, ON), (2) lentils (Primo, Toronto, ON), (3) navy beans (Ferma, Toronto, ON) or (4) yellow peas (Nupak, Toronto, ON).
Primary Outcome Measure Information:
Title
Short-term energy intake
Description
Energy intake was measured at the treatment meal (0-20 min) and at a pizza meal (second meal) provided four hours later (260-280 min).
Time Frame
over 280 min
Secondary Outcome Measure Information:
Title
Blood glucose and satiety
Description
Following treatment meal consumption, blood glucose and appetite were measured at 20, 40, 60, 110, 140, 200 and 260 min and are reported as pre-second meal values. Following the pizza meal, blood glucose and appetite were measured at 280, 300, 320 and 340 min and are reported as post-second meal values.
Time Frame
20, 40, 60, 110, 140, 200, 260, 280, 300, 320 and 340 min

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy young males with BMI of 20-24.9 kg/m2 Exclusion Criteria: Females Smokers Breakfast skippers Individuals with diabetes or other metabolic diseases Those scoring ≥ 11 on an Eating Habit Questionnaire
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
G. Harvey Anderson, PhD
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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Pulses, Satiation, Food Intake and Blood Glucose

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