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

NCT02200796 | Completed

• 1 other identifier: tempID
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity

Keywords

Dietary Protein; Satiety; Food Intake; Thermic Effect of Food; Diet Induced Thermogenesis

Outcome Measures

Primary Outcomes (1)

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

  Four hours after breakfast

Secondary Outcomes (3)

• 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

• Subjective Appetite

  Assessed every 15 min for 4 h

• Blood glucose response

  Measures at 15, or 60 min intervals for 4 h

Study Arms (4)

Low Protein Meal

EXPERIMENTAL

Low Protein Test Meal (15 g)

Other: Low Protein Meal

Moderate Protein Meal

EXPERIMENTAL

Moderate Protein Meal (30 g)

Other: Moderate Protein Meal

High Protein Meal

EXPERIMENTAL

High Protein Meal (45g)

Other: High Protein Meal

Control Meal

EXPERIMENTAL

High Carbohydrate Control Meal (7 g of protein)

Other: Control Meal

Interventions

Control Meal OTHER

High carbohydrate meal

Control Meal

Low Protein Meal OTHER

Omelet with 15 g of protein

Low Protein Meal

Moderate Protein Meal OTHER

Omelet with 30 g of protein

Moderate Protein Meal

High Protein Meal OTHER

Omelet with 45 g of protein

High Protein Meal

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• Food sensitivities
• Food allergies
• Dietary restrictions
• Health, learning, emotional or behavioural problems
• On any medication

Sponsors & Collaborators

• Toronto Metropolitan University: lead

Study Sites (1)

Ryerson University, FIRST Labaratory. 350 Victoria Street

Toronto, Ontario, M5B 2K3, Canada

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor and Director, Food Intake Regulation & Satiety

Study Record Dates

• First Submitted: July 20, 2014
• First Posted: July 25, 2014
• Study Start: April 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 30, 2020

Record last verified: 2020-09

Locations

CA (1)