NCT04396275

Brief Summary

The frequent consumption of pulses is associated with multiple cardiometabolic benefits in adults including a lower risk for overweight and obesity. However, it remains unclear whether these effects are mediated through the short-term mechanisms, including enhanced satiety and reduced food intake (FI), or through the long-term metabolic effects triggered by regular consumption of pulses. The objective of this study is to investigate the short-term effect of cooked pulses served in the amount similar to their recommended serving of 175ml (3/4 cup) on food intake in 12-14y children, and gastrointestinal comfort over 2-hours. The secondary objective is to evaluate how children perceive the sensory characteristics of the meals made with the whole pulses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

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

August 1, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 20, 2020

Completed
Last Updated

May 20, 2020

Status Verified

May 1, 2020

Enrollment Period

8 months

First QC Date

April 1, 2020

Last Update Submit

May 19, 2020

Conditions

Keywords

PulsesSatietyFood intakeAppetiteBeansPeas

Outcome Measures

Primary Outcomes (3)

  • Food intake

    The amount of energy (kcal) consumed ad libitum with the breakfast meal or water control and with the test meal (pizza lunch) two hours later.

    120 min

  • Subjective appetite

    The subjective assessment of appetite parameters including desire to eat, fullness, hunger and a prospective food consumption measured with 100 mm Visual Analogue Scales with two opposite statements at each end (e.g., for the hunger scale, 0 mm means not hungry at all, and 100 mm means very hungry).

    0-120 min

  • Subjective feeling of physical comfort

    The subjective assessment of wellness and gastrointestinal symptoms including a feeling of nausea, diarrhea, flatulence, and other parameters measured with 100 mm Visual Analogue Scales with two opposite statements at each end.

    0-120 min

Secondary Outcomes (1)

  • Subjective perception of food palatability (pleasantness)

    0, 120 min

Study Arms (3)

Cooked whole navy beans

EXPERIMENTAL

A meal consisting of cooked navy beans

Other: Food-1

Cooked whole yellow split peas

EXPERIMENTAL

A meal consisting of cooked yellow peas

Other: Food-2

Cooked rice (control)

EXPERIMENTAL

A meal consisting of cooked rice

Other: Food-3

Interventions

Food-1OTHER

Cooked whole navy beans (300 kcal)

Cooked whole navy beans
Food-2OTHER

Cooked whole yellow split peas (300 kcal)

Cooked whole yellow split peas
Food-3OTHER

Cooked rice considered as control (300 kcal)

Cooked rice (control)

Eligibility Criteria

Age12 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy boys and girls born at full-term
  • do not receive any medications

You may not qualify if:

  • Food sensitivities or allergies
  • Dietary restrictions
  • Health problems
  • Learning, emotional or behavioral problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Saint Vincent University

Halifax, Nova Scotia, B3M 2J6, Canada

Location

Study Officials

  • Bohdan Luhovyy, PhD

    Mount Saint Vincent University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2020

First Posted

May 20, 2020

Study Start

August 1, 2017

Primary Completion

March 31, 2018

Study Completion

March 31, 2018

Last Updated

May 20, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations