NCT01410851

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2009

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

Study Start

First participant enrolled

September 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 5, 2011

Completed
Last Updated

August 5, 2011

Status Verified

July 1, 2011

Enrollment Period

11 months

First QC Date

July 27, 2011

Last Update Submit

August 3, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    over 280 min

Secondary Outcomes (1)

  • Blood glucose and satiety

    20, 40, 60, 110, 140, 200, 260, 280, 300, 320 and 340 min

Study Arms (5)

Pasta, tomato sauce & added chickpeas

EXPERIMENTAL

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.

Other: dietary treatment

Pasta, tomato sauce and added lentils

EXPERIMENTAL

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.

Other: dietary treatment

Pasta, tomato sauce and added navy beans

EXPERIMENTAL

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.

Other: dietary treatment

Pasta, tomato sauce with yellow peas

EXPERIMENTAL

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.

Other: dietary treatment

Pasta and tomato sauce

EXPERIMENTAL

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.

Other: dietary treatment

Interventions

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).

Pasta and tomato saucePasta, tomato sauce & added chickpeasPasta, tomato sauce and added lentilsPasta, tomato sauce and added navy beansPasta, tomato sauce with yellow peas

Eligibility Criteria

Age20 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nutritional Sciences, University of Toronto

Toronto, Ontario, M5S 3E2, Canada

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • G. Harvey Anderson, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 27, 2011

First Posted

August 5, 2011

Study Start

September 1, 2009

Primary Completion

August 1, 2010

Study Completion

October 1, 2010

Last Updated

August 5, 2011

Record last verified: 2011-07

Locations