NCT01717716

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2011

Shorter than P25 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

June 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 30, 2012

Completed
Last Updated

October 30, 2012

Status Verified

October 1, 2012

Enrollment Period

3 months

First QC Date

October 23, 2012

Last Update Submit

October 26, 2012

Conditions

Keywords

boysobesityglucosesucrosehigh-fructose corn syrup-55

Outcome Measures

Primary Outcomes (1)

  • Food intake (kcal)

    measured at 60 minutes after the treatment

Secondary Outcomes (1)

  • Subjective appetite (mm)

    0-90 minutes

Study Arms (4)

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

water with SucraloseDIETARY_SUPPLEMENT
Calorie-free control
water with HFCSDIETARY_SUPPLEMENT
HFCS-55 drink
water with glucoseDIETARY_SUPPLEMENT
Glucose drink
water with sucroseDIETARY_SUPPLEMENT
Sucrose drink

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Girl, on restricted diet, taking medication that affect appetite or food intake, have significant learning, behavioral, or emotional difficulties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Applied Human Nutrition

Bedford, Nova Scotia, Canada

Location

MeSH Terms

Conditions

Pediatric ObesityObesity

Interventions

WatertrichlorosucroseGlucoseSucrose

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen CompoundsHexosesMonosaccharidesSugarsCarbohydratesDisaccharidesOligosaccharidesPolysaccharides

Study Officials

  • Nick Bellissimo, PhD

    Toronto Metropolitan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 23, 2012

First Posted

October 30, 2012

Study Start

June 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

October 30, 2012

Record last verified: 2012-10

Locations