Sugar Sweetened Beverages (SSB)- Effects on Metabolism
Effects of Carbohydrate Containing Diets on Lipid Metabolism & Fatty Acid Oxidation in Healthy Young Men - a Randomized, Double-Blinded Study.
1 other identifier
interventional
96
1 country
1
Brief Summary
The objective of this study is to investigate the impact of sugar sweetened beverages on the fat metabolism of healthy young men. It is well known that consumption of beverages sweetened with fructose is associated with different health risks such as type 2 diabetes. The present study has been designed to dissect differences in the metabolic pathways of fructose and glucose, but also metabolic adaptations during fructose, glucose and sucrose diets. During a period of seven weeks subjects will consume either fructose, glucose or sucrose sweetened beverages or continue their usual drinking habits. During these seven weeks there will be different metabolic investigations using stable isotope tracers. First, the rate of lipolysis and beta-oxidation will be determined. Second, the rates of fatty acid synthesis will be measured. During all examinations there will also be substrate- and energy-utilization measurements by indirect calorimetry, blood analysis and morphometric measurements. Based on the literature main hypotheses are: Fructose enhances de novo lipogenesis postprandially and also in the fasting state significantly more than glucose by enhanced expression of lipogenic enzymes. Fructose decreases beta oxidation via downregulation of oxidative enzymes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2012
CompletedFirst Posted
Study publicly available on registry
November 27, 2012
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedMay 12, 2016
May 1, 2016
3.1 years
November 9, 2012
May 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lipogenesis
Measurement of lipogenesis is based on i. v. administration of stable isotope labelled acetate (1,2-13C-acetate). 13C incorporation into palmitate is quantified by mass-spectrometry. 13C incorporation correlates to the rate of fatty acid synthesis.
After total 6 weeks dietary intervention
Secondary Outcomes (1)
Lipolysis
After total 6 weeks dietary intervention
Other Outcomes (1)
Waist/Hip Ratio
After total 6 weeks dietary intervention
Study Arms (4)
fructose sweetened beverage
EXPERIMENTALSoft drink consumption: Subjects have to drink a fructose sweetened beverage (3x 200ml per day, 13.3g fructose/100ml) during 7 weeks
glucose sweetened beverage
EXPERIMENTALSoft drink consumption: Subjects have to drink a glucose sweetened beverage (3x 200ml per day, 13.3g glucose/100ml) during 7 weeks
sucrose sweetened beverage
EXPERIMENTALSoft drink consumption: Subjects have to drink a sucrose sweetened beverage (3x 200ml per day, 13.3g sucrose/100ml) during 7 weeks
No change of eating habits
EXPERIMENTALNo Soft drink consumption (no soft drink diet): Subjects do not change their eating habits during 7 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Healthy male volunteers aged 18-30
- BMI between 19-24 kg/m2
- Non-smoker
You may not qualify if:
- Acute or chronic infections, malignant disease, renal, hepatic (more than two-fold increased transaminases), pulmonary, neurological (epilepsy) or psychiatric diseases, manifested atherosclerosis, or any other disease precluding participation in the study.
- Diabetes
- Known alcohol, substance or drug abuse, concomitant medication
- More than three hours of physical exercise per week
- Consumption of more than 2 times 3 dl SSB daily
- Subjects likely to fail to comply with the study protocol
- Subjects who do not give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Zurichlead
- SNF Swiss National Foundationcollaborator
- University of Lausannecollaborator
Study Sites (1)
University Hospital Zurich, Endocrinology and Diabetology
Zurich, Canton of Zurich, 8091, Switzerland
Related Publications (1)
Geidl-Flueck B, Hochuli M, Nemeth A, Eberl A, Derron N, Kofeler HC, Tappy L, Berneis K, Spinas GA, Gerber PA. Fructose- and sucrose- but not glucose-sweetened beverages promote hepatic de novo lipogenesis: A randomized controlled trial. J Hepatol. 2021 Jul;75(1):46-54. doi: 10.1016/j.jhep.2021.02.027. Epub 2021 Mar 6.
PMID: 33684506DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Philipp Gerber, MD
University Hospital Zurich, Endocrinology and Diabetology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2012
First Posted
November 27, 2012
Study Start
April 1, 2013
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
May 12, 2016
Record last verified: 2016-05