NCT02499107

Brief Summary

This study will compare the effects of commonly consumed carbohydrate sources such as potatoes, pasta and rice along with a fixed portion of meat on blood glucose, satiety and insulin levels among healthy body weight children. Healthy boys and girls, aged between 11 - 13 years old, will be involved in this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable obesity

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

April 1, 2013

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 15, 2015

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

2.3 years

First QC Date

July 13, 2015

Last Update Submit

May 4, 2017

Conditions

ObesityDiabetes

Keywords

food intakesatietyblood glucosepotatoinsulin

Outcome Measures

Primary Outcomes (1)

  • Food Intake

    Food intake (kCal) will be assessed 30 min after consumption of the ad libitum treatments of either rice, pasta, boiled and mashed potatoes, baked french fries or fried french fries.

    Food intake will be measured at 30 min after ad libitum carbohydrate intake

Secondary Outcomes (6)

  • blood glucose

    blood glucose will be measured at 0, 30, 45, 60, 75, 90 and 120 min - during the 2 hours study period.

  • Plasma Insulin hormone

    Insulin will be measured at 0, 30, 60 and 120 min - during the 2 hours study period.

  • Plasma Glucogan like peptide (GLP-1) hormone

    GLP-1 will be measured at 0, 30, 60 and 120 min - during the 2 hours study period.

  • Plasma ghrelin hormone

    Active ghrelin hormone will be measured at 0, 30, 60 and 120 min - during the 2 hours study period.

  • Peptide YY (PYY) hormone

    PYY hormone will be measured at 0, 30, 60 and 120 min - during the 2 hours study period.

  • +1 more secondary outcomes

Study Arms (5)

Rice treatment

EXPERIMENTAL

Dietary Intervention: Ad libitum intake of white rice

Dietary Supplement: Rice treatment

Pasta treatment

EXPERIMENTAL

Dietary Intervention: Ad libitum intake of pasta

Dietary Supplement: Pasta treatment

boiled and mashed potato treatment

EXPERIMENTAL

Dietary Intervention: Ad libitum intake of boiled and mashed potato

Dietary Supplement: Boiled and mashed potato treatment

Baked french fries treatment

EXPERIMENTAL

Dietary Intervention: Ad libitum intake of baked french fries

Dietary Supplement: Baked french fries treatment

Fried french fries treatment

EXPERIMENTAL

Dietary Intervention: Ad libitum intake of fried french fries

Dietary Supplement: Fried french fries treatment

Interventions

Rice treatmentDIETARY_SUPPLEMENT

All arms are given to all participants, in a randomized (cross over) order

Rice treatment
Pasta treatmentDIETARY_SUPPLEMENT
Pasta treatment
Boiled and mashed potato treatmentDIETARY_SUPPLEMENT
boiled and mashed potato treatment
Baked french fries treatmentDIETARY_SUPPLEMENT
Baked french fries treatment
Fried french fries treatmentDIETARY_SUPPLEMENT
Fried french fries treatment

Eligibility Criteria

Age11 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • boys and girls
  • age 11 to 13 years old
  • healthy
  • BMI-for-age percentile 15% to 85%

You may not qualify if:

  • taking any medications,
  • Parental report of children with major disease,
  • behavioral or emotional difficulties,
  • children who have a food allergy,
  • children follow a therapeutic diet, or do not habitually eat breakfast

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nutritional Sciences, FitzGerald Building

Toronto, Ontario, M5S 3E2, Canada

Location

MeSH Terms

Conditions

ObesityDiabetes MellitusInsulin Resistance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Officials

  • Harvey G Anderson, PhD

    University of Toronto, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 13, 2015

First Posted

July 15, 2015

Study Start

April 1, 2013

Primary Completion

August 1, 2015

Study Completion

December 1, 2015

Last Updated

May 8, 2017

Record last verified: 2017-05

Locations

CA(1)