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

September 28, 2020 updated by: Nick Bellissimo, Ryerson University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 2K3
        • Ryerson University, FIRST Labaratory. 350 Victoria Street

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 14 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low Protein Meal
Low Protein Test Meal (15 g)
Other: Low Protein Meal
Omelet with 15 g of protein
Experimental: Moderate Protein Meal
Moderate Protein Meal (30 g)
Other: Moderate Protein Meal
Omelet with 30 g of protein
Experimental: High Protein Meal
High Protein Meal (45g)
Other: High Protein Meal
Omelet with 45 g of protein
Experimental: Control Meal
High Carbohydrate Control Meal (7 g of protein)
Other: Control Meal
High carbohydrate meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
1a) Ad libitum food intake (in kcal)
Time Frame: Four hours after breakfast
Four hours after breakfast

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1b) The thermic effect of a high versus low protein meal
Time Frame: Resting energy expenditure (REE) at baseline and up to five hours post test meal
REE will be determined by indirect calorimetry under a ventilated hood (ParvoMedics TrueOne 2400 automated metabolic gas analysis system, Parvo Medics, USA)
Resting energy expenditure (REE) at baseline and up to five hours post test meal
Subjective Appetite
Time Frame: Assessed every 15 min for 4 h
Assessed every 15 min for 4 h
Blood glucose response
Time Frame: Measures at 15, or 60 min intervals for 4 h
Finger prick capillary blood glucose (in mmol/L) at baseline, after breakfast (30 min), at 60 min, and in 1h intervals onward
Measures at 15, or 60 min intervals for 4 h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ryerson University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

July 20, 2014

First Submitted That Met QC Criteria

July 23, 2014

First Posted (Estimate)

July 25, 2014

Study Record Updates

Last Update Posted (Actual)

September 30, 2020

Last Update Submitted That Met QC Criteria

September 28, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tempID

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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