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Dietary Carbohydrate Consumption at Breakfast on Food Intake, Glycemic Response, and Subjective Appetite

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03045354
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Nick Bellissimo, Ryerson University

Brief Summary:
The purpose of this study is to determine the effect of carbohydrates of familiar breakfast meals on glycemic response, subjective appetite, and food intake in normal weight (NW) and overweight or obese (OW/OB) children.

Condition or disease Intervention/treatment Phase
Childhood Obesity Breakfast Other: Mashed potatoes Other: Traditional breakfast Other: Breakfast skipping Other: French fries Other: Beans Not Applicable

Detailed Description:
Regular breakfast eating NW and OW/OB children, 9-14 years of age, will participate in the experiment. Four isocaloric (450 kcal) breakfasts (eggs with a side of French fries, mashed potatoes, or beans, and control breakfast of milk, cereal and toast) and breakfast skipping will be examined. On five separate mornings, 7 days apart and after a 12 hour overnight fast, each participant will receive one of the four breakfasts or skip breakfast, in a randomized counterbalanced order. Participants will be given an ad libitum lunch 3 hours after breakfast and parents will report the rest of day food record for food intake analysis. Blood glucose will be measured via finger-prick at baseline, and 30, 60, 120, and 180 minutes after breakfast consumption. Subjective appetite will be measured with a visual analogue scale at baseline and every 15 minutes for 1 hour, and every hour for 3 hours.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Carbohydrate-Containing Foods at Breakfast on Food Intake, Glycemic Response, and Subjective Appetite in Normal Weight and Overweight/Obese Children
Actual Study Start Date : October 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : September 2017

Arm Intervention/treatment
Experimental: Mashed potatoes
Eggs with a side of mashed potatoes
Other: Mashed potatoes
Isocaloric (450 kcal) breakfast treatments of eggs with a side of mashed potatoes

Experimental: French fries
Eggs with a side of French fries
Other: French fries
Isocaloric (450 kcal) breakfast treatments of eggs with a side of French fries

Experimental: Beans
Eggs with a side of beans
Other: Beans
Isocaloric (450 kcal) breakfast treatments of eggs with a side of beans

Experimental: Traditional breakfast
Cereal, milk, toast and jam
Other: Traditional breakfast
Isocaloric (450 kcal) control breakfast treatments of cereal, milk, toast and jam

Experimental: Breakfast skipping
No breakfast
Other: Breakfast skipping
No breakfast




Primary Outcome Measures :
  1. Short-term food intake (kcal) [ Time Frame: 3 hours after breakfast ]
    Participants will consume an ad libitum lunch 3 hours post breakfast consumption.


Secondary Outcome Measures :
  1. Subjective appetite [ Time Frame: Baseline, at 15 or 60 minutes intervals for 3 hours ]
    Participants will complete subjective ratings on appetite and well-being

  2. Blood glucose [ Time Frame: Baseline, 30, 60, 120 and 180 minutes after breakfast ]
    Finger prick capillary blood glucose will be collected

  3. Rest of day food record [ Time Frame: 8-12 hours ]
    Parents/guardians will record participants' food intake until the end of the day



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Ages Eligible for Study:   9 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • be between 9 and 14 years of age
  • be healthy, and have been born at term
  • not be taking any medications
  • not have allergies or sensitivities to potatoes, eggs, gluten, dairy, or beans
  • NW (between the 5th and 85th BMI percentile for age and gender)
  • OW/OB (>85th BMI percentile for age and gender)

Exclusion Criteria:

  • food sensitivities, allergies, or dietary restrictions
  • health, learning, emotional, or behavioural problems
  • receiving any medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045354


Locations
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Canada, Ontario
School of Nutrition, Ryerson University
Toronto, Ontario, Canada, M5B 2K3
Sponsors and Collaborators
Ryerson University
Investigators
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Principal Investigator: Nick Bellissimo, PhD Ryerson University

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Responsible Party: Nick Bellissimo, Associate Professor, School of Nutrition, Ryerson University
ClinicalTrials.gov Identifier: NCT03045354    
Other Study ID Numbers: REB2016-227
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nick Bellissimo, Ryerson University:
children
dietary carbohydrates
satiety
appetite
blood glucose
solanum tuberosum
obesity
breakfast
Additional relevant MeSH terms:
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Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms