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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02058914
Other study ID # fructadol
Secondary ID
Status Completed
Phase N/A
First received February 6, 2014
Last updated June 6, 2017
Start date September 2011
Est. completion date April 2013

Study information

Verified date June 2017
Source University of Missouri-Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date April 2013
Est. primary completion date April 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 20 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
high fructose sweetened beverage
710 ml per day of a HF-sweetened beverage
High Glucose sweetened beverage
HG-sweetened beverage

Locations

Country Name City State
United States University of Missouri Columbia Missouri

Sponsors (1)

Lead Sponsor Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Primary 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 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
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