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

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Control Meal
Low Protein Meal
Moderate Protein Meal
High Protein Meal
Sponsored by
Toronto Metropolitan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring Dietary Protein, Satiety, Food Intake, Thermic Effect of Food, Diet Induced Thermogenesis

Eligibility Criteria

9 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ryerson University, FIRST Labaratory. 350 Victoria Street

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Low Protein Meal

Moderate Protein Meal

High Protein Meal

Control Meal

Arm Description

Low Protein Test Meal (15 g)

Moderate Protein Meal (30 g)

High Protein Meal (45g)

High Carbohydrate Control Meal (7 g of protein)

Outcomes

Primary Outcome Measures

1a) Ad libitum food intake (in kcal)

Secondary Outcome Measures

1b) The thermic effect of a high versus low protein meal
REE will be determined by indirect calorimetry under a ventilated hood (ParvoMedics TrueOne 2400 automated metabolic gas analysis system, Parvo Medics, USA)
Subjective Appetite
Blood glucose response
Finger prick capillary blood glucose (in mmol/L) at baseline, after breakfast (30 min), at 60 min, and in 1h intervals onward

Full Information

First Posted
July 20, 2014
Last Updated
September 28, 2020
Sponsor
Toronto Metropolitan University
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1. Study Identification

Unique Protocol Identification Number
NCT02200796
Brief Title
Role of Dietary Protein on Satiety, Food Intake and Thermic Effect of Food
Official Title
Role of Dietary Protein in a Familiar Breakfast Meal on Subjective Satiety, Food Intake and Thermic Effect of Food in Normal Weight and Overweight/Obese Children
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Toronto Metropolitan University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Dietary Protein, Satiety, Food Intake, Thermic Effect of Food, Diet Induced Thermogenesis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Low Protein Meal
Arm Type
Experimental
Arm Description
Low Protein Test Meal (15 g)
Arm Title
Moderate Protein Meal
Arm Type
Experimental
Arm Description
Moderate Protein Meal (30 g)
Arm Title
High Protein Meal
Arm Type
Experimental
Arm Description
High Protein Meal (45g)
Arm Title
Control Meal
Arm Type
Experimental
Arm Description
High Carbohydrate Control Meal (7 g of protein)
Intervention Type
Other
Intervention Name(s)
Control Meal
Intervention Description
High carbohydrate meal
Intervention Type
Other
Intervention Name(s)
Low Protein Meal
Intervention Description
Omelet with 15 g of protein
Intervention Type
Other
Intervention Name(s)
Moderate Protein Meal
Intervention Description
Omelet with 30 g of protein
Intervention Type
Other
Intervention Name(s)
High Protein Meal
Intervention Description
Omelet with 45 g of protein
Primary Outcome Measure Information:
Title
1a) Ad libitum food intake (in kcal)
Time Frame
Four hours after breakfast
Secondary Outcome Measure Information:
Title
1b) The thermic effect of a high versus low protein meal
Description
REE will be determined by indirect calorimetry under a ventilated hood (ParvoMedics TrueOne 2400 automated metabolic gas analysis system, Parvo Medics, USA)
Time Frame
Resting energy expenditure (REE) at baseline and up to five hours post test meal
Title
Subjective Appetite
Time Frame
Assessed every 15 min for 4 h
Title
Blood glucose response
Description
Finger prick capillary blood glucose (in mmol/L) at baseline, after breakfast (30 min), at 60 min, and in 1h intervals onward
Time Frame
Measures at 15, or 60 min intervals for 4 h

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Ryerson University, FIRST Labaratory. 350 Victoria Street
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 2K3
Country
Canada

12. IPD Sharing Statement

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

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