Sugars-sweetened Beverages and Exercise on Glycaemic Resp... | NCT02197195

Studies
Sugars-sweetened Beverages and Exercise on Glycaemic Response and Subjective Appetite in Children

NCT02197195

Sponsor

Toronto Metropolitan University

Status

Completed

Last Update Posted

Jul 22, 2014Estimated

Enrollment

8Actual

Phase

Not Applicable

Conditions

Glycemic Control
Subjective Appetite

Interventions

Chocolate Milk
Fruit Drink
Exercise

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Apr 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

Jul 20, 2014

First Submission Date that Met QC Criteria

Jul 20, 2014

First Posted Date

Jul 22, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2014

Last Update Posted Date

Jul 22, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nick Bellissimo, Assistant Professor, School of Nutrition, Toronto Metropolitan UniversityPrincipal Investigator

Lead Sponsor

Toronto Metropolitan UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to understand the role chocolate milk compared to a fruit drink, with and without exercise, on glycaemic regulation and subjective appetite in children. The investigators hypothesize that chocolate milk in combination with exercise will have the greatest effect attenuating glycaemic response. Blood glucose will be measured by finger prick following drink consumption (0 min) and exercise or sitting (15 min), and at 65 minutes. Subjective appetite will be measured at 0, 20, 35, 50 and 65 minutes.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chocolate Milk Beverage	Experimental	Chocolate milk beverage and sitting quietly	Dietary Supplement: Chocolate Milk
Chocolate Milk Beverage and Exercise	Experimental	Chocolate milk beverage and exercising	Dietary Supplement: Chocolate Milk Behavioral: Exercise
Fruit Drink Beverage	Experimental	Fruit drink beverage and sitting quietly	Dietary Supplement: Fruit Drink
Fruit Drink Beverage and Exercise	Experimental	Fruit drink beverage and exercising	Dietary Supplement: Fruit Drink Behavioral: Exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chocolate Milk	Dietary Supplement		Chocolate Milk Beverage Chocolate Milk Beverage and Exercise
Fruit Drink

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood Glucose (mmol/L)	Blood Glucose (mmol/L) determined by fingerprick glucometer reading	at baseline (0), 20 and 65 minutes

Secondary Outcomes

Measure	Description	Time Frame
Subjective Appetite (mm)	Subjective appetite (in mm) determined by visual analogue scale will be determined at 0, 20, 35, 50 and 65 minutes.	0 - 65 mins

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy, boy, born at full term and normal birth weight

Exclusion Criteria:

Girls, have significant learning, behavioral, or emotional difficulties

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

14 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ryerson University		Toronto	Ontario	KHS344	Canada

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided