NCT02058914

Brief Summary

We examined the effects of short-term (2-wk) consumption of HF- and HG-sweetened beverages in adolescents (15-20 yr of age) on insulin sensitivity, insulin secretion, insulin clearance, triacylglycerol (TAG), and cholesterol concentrations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2011

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

September 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 10, 2014

Completed
Last Updated

June 8, 2017

Status Verified

June 1, 2017

Enrollment Period

1.6 years

First QC Date

February 6, 2014

Last Update Submit

June 6, 2017

Conditions

Insulin SensitivityInsulin Tolerance

Keywords

Sugar sweetened beveragesmetabolismendocrinelipidsblood glucose

Outcome Measures

Primary Outcomes (1)

  • glucose concentrations

    baseline and 15, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 255, 270, 285, 300, 315, 330, 360, 390, 420, 450, 480, 495, 510, 525, 540, 555, 570, 600, 630, 660, 690, and 720

Secondary Outcomes (1)

  • Triglycerides

    baseline and 15, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 255, 270, 285, 300, 315, 330, 360, 390, 420, 450, 480, 495, 510, 525, 540, 555, 570, 600, 630, 660, 690, and 720

Other Outcomes (1)

  • insulin

    baseline and 15, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 255, 270, 285, 300, 315, 330, 360, 390, 420, 450, 480, 495, 510, 525, 540, 555, 570, 600, 630, 660, 690, and 720

Study Arms (2)

high fructose sweetened beverage

EXPERIMENTAL

710 ml per day of a HF-sweetened beverage (sweetened with 50 g fructose and 15 g glucose)

Dietary Supplement: high fructose sweetened beverage

High Glucose sweetened beverage

ACTIVE COMPARATOR

HG-sweetened beverage (sweetened with 50 g glucose and 15 g fructose)

Dietary Supplement: High Glucose sweetened beverage

Interventions

high fructose sweetened beverageDIETARY_SUPPLEMENT

710 ml per day of a HF-sweetened beverage

high fructose sweetened beverage
High Glucose sweetened beverageDIETARY_SUPPLEMENT

HG-sweetened beverage

High Glucose sweetened beverage

Eligibility Criteria

Age15 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • males and females 15-20 years of age not participating in an organized sport (non-athletes) no history of heart, lung, kidney, endocrine, or gastrointestinal disease no medications known to alter glucose or lipid metabolism normal fasting blood glucose concentrations (\< 100 mg/dL) normal fasting triglyceride concentrations (\< 150 mg/dL) average daily fructose consumption \< 90th percentile for age and sex

You may not qualify if:

  • athlete type 1 diabetic type 2 diabetic consuming high quantities of fructose

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri

Columbia, Missouri, 65211, United States

Location

Related Publications (1)

  • Heden TD, Liu Y, Park YM, Nyhoff LM, Winn NC, Kanaley JA. Moderate amounts of fructose- or glucose-sweetened beverages do not differentially alter metabolic health in male and female adolescents. Am J Clin Nutr. 2014 Sep;100(3):796-805. doi: 10.3945/ajcn.113.081232. Epub 2014 Jul 16.

    PMID: 25030782DERIVED

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jill Kanaley, PhD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 6, 2014

First Posted

February 10, 2014

Study Start

September 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

June 8, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)