Sweetened Beverages and Food Intake
2 other identifiers
interventional
10
1 country
1
Brief Summary
The purpose of this study is to investigate whether beverages sweetened with fructose promote overconsumption of calories as compared to beverages sweetened with glucose or a non-caloric sweetener.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2007
Longer than P75 for not_applicable
1 active site
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
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 16, 2007
CompletedFirst Posted
Study publicly available on registry
May 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedMay 2, 2012
April 1, 2012
4.6 years
May 16, 2007
April 30, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total energy consumed in the three diet periods.
8 days in each period
Secondary Outcomes (4)
Resting energy expenditure
After 8 days of each dietary phase
Fasting and postprandial plasma concentrations of satiety and adiposity signals.
After 8 days of each dietary phase
Fasting and postprandial plasma lipid and lipoprotein concentrations.
After 8 days of each dietary phase
Fasting plasma concentrations of inflammatory mediators.
After 8 days of each dietary phase
Study Arms (3)
1
EXPERIMENTALFructose-sweetened beverage Subjects will be asked to drink 4 servings of a beverage sweetened with 100% fructose per day for 8 days, while consuming an ad libitum diet (same solid food for all three diet periods).
2
EXPERIMENTALGlucose-sweetened beverage Subjects will be asked to drink 4 servings of a beverage sweetened with 100% glucose per day for 8 days, while consuming an ad libitum diet (same solid food for all three diet periods).
3
PLACEBO COMPARATORBeverage sweetened with a non-caloric sweetener Subjects will be asked to drink 4 servings of a beverage sweetened with a non-caloric sweetener per day for 8 days, while consuming an ad libitum diet (same solid food for all three diet periods).
Interventions
25% of energy intake in the form of a fructose-sweetened beverage (arm 1), a glucose-sweetened beverage (arm 2), or an isovolumetric amount of a beverage sweetened with a non-caloric sweetener
25% of energy intake in the form of a fructose-sweetened beverage (arm 1), a glucose-sweetened beverage (arm 2), or an isovolumetric amount of a beverage sweetened with a non-caloric sweetener
25% of energy intake in the form of a fructose-sweetened beverage (arm 1), a glucose-sweetened beverage (arm 2), or an isovolumetric amount of a beverage sweetened with a non-caloric sweetener
Eligibility Criteria
You may qualify if:
- Age: 18-25 years
- Body mass index: 20-25 kg/m2
- Weight stable to within 5 pounds for 6 months prior to entering the study
- Within 10 pounds of their lifetime maximum weight
- Ability to be admitted for 5 hours to the General Clinical Research Center of the University of Washington on three occasions
- Ability to provide informed written consent
- Willingness to consume only food provided by the Nutrition Research Kitchen of the University of Washington General Clinical Research Center for three periods of 8 days each
You may not qualify if:
- History of cardiovascular disease
- Presence of diabetes mellitus or impaired glucose tolerance (fasting glucose \> 100 mg/dL)
- Presence of hypertension (blood pressure systolic/diastolic higher than 140/90)
- Presence of phenylketonuria
- Presence of fructose malabsorption or hereditary fructose intolerance
- Presence of another chronic or psychiatric illness
- Use of anabolic steroids, glucocorticoids, warfarin, beta-blockers, antidepressants, or lipid-lowering agents
- Use of antibiotic drugs within 3 months of enrollment into the study
- Use of tobacco products
- Pregnancy or female subject not using contraception
- Regular intense exercise (\> 3 hour per week)
- Vegetarian or extreme dietary preferences
- Alcohol consumption of more than 2 drinks per day
- Presence of eating disorder
- History of frequent attempts at weight loss
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- Seattle Children's Hospitalcollaborator
Study Sites (1)
University of Washington General Clinical Research Center
Seattle, Washington, 98195, United States
Related Publications (1)
Kuzma JN, Cromer G, Hagman DK, Breymeyer KL, Roth CL, Foster-Schubert KE, Holte SE, Callahan HS, Weigle DS, Kratz M. No difference in ad libitum energy intake in healthy men and women consuming beverages sweetened with fructose, glucose, or high-fructose corn syrup: a randomized trial. Am J Clin Nutr. 2015 Dec;102(6):1373-80. doi: 10.3945/ajcn.115.116368. Epub 2015 Nov 4.
PMID: 26537945DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mario Kratz, Ph.D.
University of Washington
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant Professor
Study Record Dates
First Submitted
May 16, 2007
First Posted
May 21, 2007
Study Start
May 1, 2007
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
May 2, 2012
Record last verified: 2012-04