NCT03045354

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 7, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

July 23, 2018

Status Verified

July 1, 2018

Enrollment Period

8 months

First QC Date

February 3, 2017

Last Update Submit

July 19, 2018

Conditions

Keywords

childrendietary carbohydratessatietyappetiteblood glucosesolanum tuberosumobesitybreakfast

Outcome Measures

Primary Outcomes (1)

  • Short-term food intake (kcal)

    Participants will consume an ad libitum lunch 3 hours post breakfast consumption.

    3 hours after breakfast

Secondary Outcomes (3)

  • Subjective appetite

    Baseline, at 15 or 60 minutes intervals for 3 hours

  • Blood glucose

    Baseline, 30, 60, 120 and 180 minutes after breakfast

  • Rest of day food record

    8-12 hours

Study Arms (5)

Mashed potatoes

EXPERIMENTAL

Eggs with a side of mashed potatoes

Other: Mashed potatoes

French fries

EXPERIMENTAL

Eggs with a side of French fries

Other: French fries

Beans

EXPERIMENTAL

Eggs with a side of beans

Other: Beans

Traditional breakfast

EXPERIMENTAL

Cereal, milk, toast and jam

Other: Traditional breakfast

Breakfast skipping

EXPERIMENTAL

No breakfast

Other: Breakfast skipping

Interventions

Isocaloric (450 kcal) breakfast treatments of eggs with a side of mashed potatoes

Mashed potatoes

Isocaloric (450 kcal) control breakfast treatments of cereal, milk, toast and jam

Traditional breakfast

No breakfast

Breakfast skipping

Isocaloric (450 kcal) breakfast treatments of eggs with a side of French fries

French fries
BeansOTHER

Isocaloric (450 kcal) breakfast treatments of eggs with a side of beans

Beans

Eligibility Criteria

Age9 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nutrition, Ryerson University

Toronto, Ontario, M5B 2K3, Canada

Location

MeSH Terms

Conditions

Pediatric ObesityObesity

Interventions

lunatusin, Phaseolus lunatus

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nick Bellissimo, PhD

    Toronto Metropolitan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, School of Nutrition

Study Record Dates

First Submitted

February 3, 2017

First Posted

February 7, 2017

Study Start

October 1, 2016

Primary Completion

June 1, 2017

Study Completion

September 1, 2017

Last Updated

July 23, 2018

Record last verified: 2018-07

Locations