Sugar Sweetened Beverages (SSB)- Effects on Metabolism
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ClinicalTrials.gov Identifier: NCT01733563 |
Recruitment Status :
Completed
First Posted : November 27, 2012
Last Update Posted : May 12, 2016
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Sponsor:
University of Zurich
Collaborators:
SNF Swiss National Foundation
University of Lausanne
Information provided by (Responsible Party):
University of Zurich
Tracking Information | ||||
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First Submitted Date ICMJE | November 9, 2012 | |||
First Posted Date ICMJE | November 27, 2012 | |||
Last Update Posted Date | May 12, 2016 | |||
Study Start Date ICMJE | April 2013 | |||
Actual Primary Completion Date | May 2016 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Lipogenesis [ Time Frame: After total 6 weeks dietary intervention ] 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.
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Original Primary Outcome Measures ICMJE |
Lipogenesis [ Time Frame: After total 8 weeks dietary intervention ] Measurement of lipogenesis is based on i. v. administration of stable isotope labelled acetat (1,2-13C-acetat). 13C incorporation into palmitat is quantified by mass-spectrometry. 13C incorporation correlates to the rate of fatty acid synthesis.
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
Lipolysis [ Time Frame: After total 6 weeks dietary intervention ] Measurements using stable isotopes
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Original Secondary Outcome Measures ICMJE |
Lipolysis [ Time Frame: After total 8 weeks dietary intervention ] Measurements using stable isotops
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Current Other Pre-specified Outcome Measures |
Waist/Hip Ratio [ Time Frame: After total 6 weeks dietary intervention ] Measurement waist/hip ratio using a nonstretchable band
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Original Other Pre-specified Outcome Measures |
Waist/Hip Ratio [ Time Frame: After total 8 weeks dietary intervention ] Measurement waist/hip ratio using a nonstretchable band
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Descriptive Information | ||||
Brief Title ICMJE | Sugar Sweetened Beverages (SSB)- Effects on Metabolism | |||
Official Title ICMJE | Effects of Carbohydrate Containing Diets on Lipid Metabolism & Fatty Acid Oxidation in Healthy Young Men - a Randomized, Double-Blinded Study. | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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Condition ICMJE | Metabolism | |||
Intervention ICMJE | Procedure: Soft drink consumption | |||
Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
96 | |||
Original Estimated Enrollment ICMJE |
120 | |||
Actual Study Completion Date ICMJE | May 2016 | |||
Actual Primary Completion Date | May 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 30 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Switzerland | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01733563 | |||
Other Study ID Numbers ICMJE | SSB-Effects on metabolism | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | University of Zurich | |||
Study Sponsor ICMJE | University of Zurich | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University of Zurich | |||
Verification Date | May 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |