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Completed

NCT Number: NCT02200796

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

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

9 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ryerson University, FIRST Labaratory. 350 Victoria Street

Toronto, Ontario, M5B 2K3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control meal

Other

High carbohydrate meal

Low Protein Meal

Other

Omelet with 15 g of protein

Moderate Protein Meal

Other

Omelet with 30 g of protein

High protein meal

Other

Omelet with 45 g of protein

Primary outcomes

  1. 1a) Ad libitum food intake (in kcal)

    Time frame: Four hours after breakfast

Secondary outcomes

  1. 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)

  2. Subjective Appetite

    Time frame: Assessed every 15 min for 4 h

  3. 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

Sponsors and collaborators

Lead sponsor

Toronto Metropolitan University

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 25, 2014
Registry last updated
Sep 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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