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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04396275
Other study ID # 2017-002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2017
Est. completion date March 31, 2018

Study information

Verified date May 2020
Source Mount Saint Vincent University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date March 31, 2018
Est. primary completion date March 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 14 Years
Eligibility Inclusion Criteria:

- Healthy boys and girls born at full-term

- do not receive any medications

Exclusion Criteria:

- Food sensitivities or allergies

- Dietary restrictions

- Health problems

- Learning, emotional or behavioral problems.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Food-1
Cooked whole navy beans (300 kcal)
Food-2
Cooked whole yellow split peas (300 kcal)
Food-3
Cooked rice considered as control (300 kcal)

Locations

Country Name City State
Canada Mount Saint Vincent University Halifax Nova Scotia

Sponsors (1)

Lead Sponsor Collaborator
Mount Saint Vincent University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Subjective perception of food palatability (pleasantness) The pleasantness of the meals measured with 100 mm Visual Analogue Scales with two opposite statements at each end (e.g., 0 mm means that food is not pleasant at all, and 100 mm means that the food is very pleasant). 0, 120 min
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