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Effects of Sugar Sweetened Beverage on Metabolic Health in Male and Female Adolescents (adol)

Primary Purpose

Insulin Sensitivity, Insulin Tolerance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
high fructose sweetened beverage
High Glucose sweetened beverage
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Insulin Sensitivity focused on measuring Sugar sweetened beverages, metabolism, endocrine, lipids, blood glucose

Eligibility Criteria

15 Years - 20 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • University of Missouri

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

high fructose sweetened beverage

High Glucose sweetened beverage

Arm Description

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

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

Outcomes

Primary Outcome Measures

glucose concentrations

Secondary Outcome Measures

Triglycerides

Full Information

First Posted
February 6, 2014
Last Updated
June 6, 2017
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT02058914
Brief Title
Effects of Sugar Sweetened Beverage on Metabolic Health in Male and Female Adolescents
Acronym
adol
Official Title
Moderate Amounts of High Fructose- or High Glucose-sweetened Beverages do Not Differentially Alter Metabolic Health in Male and Female Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This counterbalanced study consisted of two trials including 1) high fructose (HF) trial and, 2) a high glucose (HG) trial. Each trial was blind to the participant, performed in a random order, and was 15 d in length. During days 1-14 of each trial, the participants consumed either 710 ml per day of a HF-sweetened beverage (sweetened with 50 g fructose and 15 g glucose) for 2-wk (HF trial) or 710 ml per day of a HG-sweetened beverage (sweetened with 50 g glucose and 15 g fructose) for 2-wk (HG trial) on top of their normal diet. In addition, the participants were instructed to maintain their normal physical activity levels during each trial (which were measured with an accelerometer). On day 15 of each trial, the participants reported to the lab after a ~ 11 h overnight fast for metabolic testing. During this testing day, the participants remained in the lab for 12 h and consumed three liquid meals (one meal every 4 h and HF meals during HF trial and HG meals during HG trial), while blood samples were taken every 15 or 30 min throughout the 12 h testing day. During testing, the participants remained physically inactive (< 3,000 steps).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Sensitivity, Insulin Tolerance
Keywords
Sugar sweetened beverages, metabolism, endocrine, lipids, blood glucose

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
high fructose sweetened beverage
Arm Type
Experimental
Arm Description
710 ml per day of a HF-sweetened beverage (sweetened with 50 g fructose and 15 g glucose)
Arm Title
High Glucose sweetened beverage
Arm Type
Active Comparator
Arm Description
HG-sweetened beverage (sweetened with 50 g glucose and 15 g fructose)
Intervention Type
Dietary Supplement
Intervention Name(s)
high fructose sweetened beverage
Intervention Description
710 ml per day of a HF-sweetened beverage
Intervention Type
Dietary Supplement
Intervention Name(s)
High Glucose sweetened beverage
Intervention Description
HG-sweetened beverage
Primary Outcome Measure Information:
Title
glucose concentrations
Time Frame
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 Outcome Measure Information:
Title
Triglycerides
Time Frame
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 Pre-specified Outcome Measures:
Title
insulin
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: athlete type 1 diabetic type 2 diabetic consuming high quantities of fructose
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill Kanaley, PhD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65211
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25030782
Citation
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.
Results Reference
derived

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Effects of Sugar Sweetened Beverage on Metabolic Health in Male and Female Adolescents

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