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

Not Applicable

Completed

• Conditions: Overweight; Obesity
• Interventions: Other: Low Protein Meal; Other: High Protein Meal; Other: Moderate Protein Meal; Other: Control Meal

• Registration Number: NCT02200796
• Lead Sponsor: Toronto Metropolitan University

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-07-20
• Study First Submitted QC: 2014-07-23
• Study First Posted: 2014-07-25
• Primary Completion: 2014-08
• Study Completion: 2014-12
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-28
• Last Update Posted: 2020-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low Protein Meal	Low Protein Meal	Low Protein Test Meal (15 g)
High Protein Meal	High Protein Meal	High Protein Meal (45g)
Moderate Protein Meal	Moderate Protein Meal	Moderate Protein Meal (30 g)
Control Meal	Control Meal	High Carbohydrate Control Meal (7 g of protein)

Primary Outcome Measures

Name	Time	Method
1a) Ad libitum food intake (in kcal)	Four hours after breakfast

Secondary Outcome Measures

Name	Time	Method
1b) The thermic effect of a high versus low protein meal	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)
Subjective Appetite	Assessed every 15 min for 4 h
Blood glucose response	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

Trial Locations

Locations (1)

Ryerson University, FIRST Labaratory. 350 Victoria Street; 🇨🇦 Toronto, Ontario, Canada