Sugars-containing Beverage and Food Intake in Children | NCT01717716

Studies
Sugars-containing Beverage and Food Intake in Children

NCT01717716

Sponsor

Toronto Metropolitan University

Status

Completed

Last Update Posted

Oct 30, 2012Estimated

Enrollment

15Actual

Phase

Not Applicable

Conditions

Childhood Obesity

Interventions

water with Sucralose
water with HFCS
water with glucose
water with sucrose

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

Oct 2012

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

Jun 2011

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Oct 23, 2012

First Submission Date that Met QC Criteria

Oct 26, 2012

First Posted Date

Oct 30, 2012Estimated

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

Oct 26, 2012

Last Update Posted Date

Oct 30, 2012Estimated

Name	Class
Mount Saint Vincent University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 is to determine the effect of sugars in solution on food intake and subjective appetite in 9- to 14-year-old normal weight boys. The investigators hypothesize that food intake after all sugars-containing solutions will be decreased in comparison to the control solution, with similar reductions in FI between high-fructose corn syrup -55 (HFCS-55) and sucrose. Food intake will be measured 60 minutes after consumption of 50g of HFCS-55, sucrose or glucose, or a control treatment. Subjective appetite will be measured at 15, 30, 45, 60 and 90 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

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Calorie-free control	Experimental	Calorie-free control	Dietary Supplement: water with Sucralose
HFCS-55 drink	Experimental	HFCS-55 drink	Dietary Supplement: water with HFCS
Glucose drink	Experimental	Glucose drink	Dietary Supplement: water with glucose
Sucrose drink	Experimental	Sucrose drink	Dietary Supplement: water with sucrose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
water with Sucralose	Dietary Supplement		Calorie-free control
water with HFCS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Food intake (kcal)		measured at 60 minutes after the treatment

Secondary Outcomes

Measure	Description	Time Frame
Subjective appetite (mm)	Subjective appetite (in mm) by visual analogue scale will be determined at 0, 15, 30, 45, 60 and 90 minutes.	0-90 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Girl, on restricted diet, taking medication that affect appetite or food intake, 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

Name	Affiliation	Role
Nick Bellissimo, PhD	Toronto Metropolitan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Applied Human Nutrition		Bedford	Nova Scotia		Canada

Condition Browse Module

MeSH Terms

ID	Term
D063766	Pediatric Obesity
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014867	Water
C026285	trichlorosucrose
D005947	Glucose
D013395	Sucrose

Ancestor Terms

ID	Term
D006878	Hydroxides
D000468	Alkalies
D007287	Inorganic Chemicals
D000838	Anions
D007477

Browse Leaves

Not provided

Browse Branches

Not provided