Role of Dietary Protein on Satiety, Food Intake and Thermic Effect of Food

NCT ID: NCT02200796

Last Updated: 2020-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-12-31

Brief Summary

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Objectives: To determine the effect of protein content of familiar breakfast meals on subjective appetite, food intake (FI), glycemic response and Thermic Effect of Food (TEF) in normal weight (NW) and overweight (OW)/obese (OB) children.

Specific Objectives:

1a.To determine the effect of familiar breakfast meals (450 kcal containing eggs and varying in protein content (15, 30, and 45g) on subjective appetite, glycemic response and food intake at a test meal 4 h later in NW and. OW/OB children.

1b. To describe the effect of isocaloric (450 kcal) familiar breakfasts either high in protein (optimal protein from Objective 1a) or low in protein on TEF and substrate utilization over 5 h in NW and OW/OB children.

Detailed Description

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Hypothesis: The investigators hypothesize that increasing the high-quality protein content of a breakfast meal will dose dependently increase subjective satiety, lower FI and glycemic response, and increase the TEF in both NW and OW/OB children.

Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Low Protein Meal

Low Protein Test Meal (15 g)

Group Type EXPERIMENTAL

Low Protein Meal

Intervention Type OTHER

Omelet with 15 g of protein

Moderate Protein Meal

Moderate Protein Meal (30 g)

Group Type EXPERIMENTAL

Moderate Protein Meal

Intervention Type OTHER

Omelet with 30 g of protein

High Protein Meal

High Protein Meal (45g)

Group Type EXPERIMENTAL

High Protein Meal

Intervention Type OTHER

Omelet with 45 g of protein

Control Meal

High Carbohydrate Control Meal (7 g of protein)

Group Type EXPERIMENTAL

Control Meal

Intervention Type OTHER

High carbohydrate meal

Interventions

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Control Meal

High carbohydrate meal

Intervention Type OTHER

Low Protein Meal

Omelet with 15 g of protein

Intervention Type OTHER

Moderate Protein Meal

Omelet with 30 g of protein

Intervention Type OTHER

High Protein Meal

Omelet with 45 g of protein

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Boys and girls between the ages of 9 and 14 y
* Only peri-pubertal girls
* Normal body weight (between the 5th and 85th BMI percentile for age and gender)
* OW/OB (\>85th BMI percentile for age and gender)

Exclusion Criteria

* Food sensitivities
* Food allergies
* Dietary restrictions
* Health, learning, emotional or behavioural problems
* On any medication
Minimum Eligible Age

9 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Toronto Metropolitan University

OTHER

Sponsor Role lead

Responsible Party

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Nick Bellissimo

Assistant Professor and Director, Food Intake Regulation & Satiety

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ryerson University, FIRST Labaratory. 350 Victoria Street

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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tempID

Identifier Type: -

Identifier Source: org_study_id

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