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

Study Overview
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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.

Official Title
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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

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Other: Control Meal
* Other: Low Protein Meal
* Other: Moderate Protein Meal
* Other: High Protein Meal


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Subjective Appetite |  | Assessed every 15 min for 4 h | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dietary Protein, Satiety, Food Intake, Thermic Effect of Food, Diet Induced Thermogenesis