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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02200796
• Other study ID #: tempID
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: December 2014

Study information

• Verified date: September 2020
• Source: Ryerson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Other:
• Control Meal
High carbohydrate meal
• Low Protein Meal
Omelet with 15 g of protein
• Moderate Protein Meal
Omelet with 30 g of protein
• High Protein Meal
Omelet with 45 g of protein

Locations

Country	Name	City	State
Canada	Ryerson University, FIRST Labaratory. 350 Victoria Street	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ryerson University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1a) Ad libitum food intake (in kcal)		Four hours after breakfast
Secondary	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)	Resting energy expenditure (REE) at baseline and up to five hours post test meal
Secondary	Subjective Appetite		Assessed every 15 min for 4 h
Secondary	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	Measures at 15, or 60 min intervals for 4 h