NCT02484313

Brief Summary

Dairy products have a potential to be healthy snack foods for children. The purpose of this project is to investigate the short-term effects of Greek yogurt, a new popular dairy product on the regulation of glucose homeostasis, satiety and energy intake in normal weight and overweight/obese children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2011

Typical duration for not_applicable

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

November 1, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 29, 2015

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

2.8 years

First QC Date

April 17, 2015

Last Update Submit

January 21, 2019

Conditions

Blood GlucoseEnergy Intake

Outcome Measures

Primary Outcomes (3)

  • blood glucose

    concentration of blood glucose

    120 min

  • insulin

    concentration of circulating insulin

    120 min

  • C-peptide

    concentration of circulating C-peptide

    120 min

Secondary Outcomes (2)

  • Food intake (grams and kcal)

    120 min

  • Subjective appetite

    0-120 min

Study Arms (2)

Greek yogurt

EXPERIMENTAL

25 g available carbohydrates

Other: dietary treatments

Cookies

EXPERIMENTAL

25 g available carbohydrates

Other: dietary treatments

Interventions

dietary treatmentsOTHER

commercially available food products

CookiesGreek yogurt

Eligibility Criteria

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

You may qualify if:

  • The children must be born at full-term within the normal weight range

You may not qualify if:

  • food sensitivities or allergies, dietary restrictions, health, learning, emotional or behavioural problems, of if children are receiving medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Saint Vincent University

Halifax, Nova Scotia, B3M 2J6, Canada

Location

Study Officials

  • Harvey Anderson, PhD

    University of 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
SPONSOR

Study Record Dates

First Submitted

April 17, 2015

First Posted

June 29, 2015

Study Start

November 1, 2011

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

January 23, 2019

Record last verified: 2019-01

Locations

CA(1)