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

• Sponsor: Ryerson University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02200796
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Arms: 4
• Duration (Months): 8
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight; Obesity	Other: Control Meal; Other: Low Protein Meal; Other: Moderate Protein Meal; Other: High Protein Meal	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• 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
• Study Start Date: Apr 1, 2014
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low Protein Meal Low Protein Test Meal (15 g)	Other: Low Protein Meal; Omelet with 15 g of protein
Experimental: Moderate Protein Meal Moderate Protein Meal (30 g)	Other: Moderate Protein Meal; Omelet with 30 g of protein
Experimental: High Protein Meal High Protein Meal (45g)	Other: High Protein Meal; Omelet with 45 g of protein
Experimental: Control Meal High Carbohydrate Control Meal (7 g of protein)	Other: Control Meal; High carbohydrate meal

Outcome Measures

Primary Outcome Measures

1. 1a) Ad libitum food intake (in kcal) [Four hours after breakfast]

Secondary Outcome Measures

1. 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)

2. Subjective Appetite [Assessed every 15 min for 4 h]

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Years to 14 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ryerson University, FIRST Labaratory. 350 Victoria Street	Toronto	Ontario	Canada	M5B 2K3

Sponsors and Collaborators

• Ryerson University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nick Bellissimo, Assistant Professor and Director, Food Intake Regulation & Satiety, Ryerson University
• ClinicalTrials.gov Identifier: NCT02200796
• Other Study ID Numbers: tempID
• First Posted: Jul 25, 2014
• Last Update Posted: Sep 30, 2020
• Last Verified: Sep 1, 2020

• Keywords provided by Nick Bellissimo, Assistant Professor and Director, Food Intake Regulation & Satiety, Ryerson University: Dietary Protein; Satiety; Food Intake; Thermic Effect of Food; Diet Induced Thermogenesis
• Additional relevant MeSH terms: Overweight

Study Results

No Results Posted as of Sep 30, 2020