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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
Sponsor:
Collaborators:
SNF Swiss National Foundation
University of Lausanne
Information provided by (Responsible Party):
University of Zurich

Tracking Information
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
 (submitted: June 27, 2013)		 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 26, 2012)		 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2013)		 Lipolysis [ Time Frame: After total 6 weeks dietary intervention ]
Measurements using stable isotopes
Original Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2012)		 Lipolysis [ Time Frame: After total 8 weeks dietary intervention ]
Measurements using stable isotops
Current Other Pre-specified Outcome Measures
 (submitted: June 27, 2013)		 Waist/Hip Ratio [ Time Frame: After total 6 weeks dietary intervention ]
Measurement waist/hip ratio using a nonstretchable band
Original Other Pre-specified Outcome Measures
 (submitted: November 26, 2012)		 Waist/Hip Ratio [ Time Frame: After total 8 weeks dietary intervention ]
Measurement waist/hip ratio using a nonstretchable band
 
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
Condition  ICMJE Metabolism
Intervention  ICMJE Procedure: Soft drink consumption
Study Arms  ICMJE
  • Experimental: fructose sweetened beverage

    Soft drink consumption:

    Subjects have to drink a fructose sweetened beverage (3x 200ml per day, 13.3g fructose/100ml) during 7 weeks

    Intervention: Procedure: Soft drink consumption
  • Experimental: glucose sweetened beverage

    Soft drink consumption:

    Subjects have to drink a glucose sweetened beverage (3x 200ml per day, 13.3g glucose/100ml) during 7 weeks

    Intervention: Procedure: Soft drink consumption
  • Experimental: sucrose sweetened beverage

    Soft drink consumption:

    Subjects have to drink a sucrose sweetened beverage (3x 200ml per day, 13.3g sucrose/100ml) during 7 weeks

    Intervention: Procedure: Soft drink consumption
  • Experimental: No change of eating habits

    No Soft drink consumption (no soft drink diet):

    Subjects do not change their eating habits during 7 weeks

    Intervention: Procedure: Soft drink consumption
Publications * Geidl-Flueck B, Hochuli M, Németh Á, Eberl A, Derron N, Köfeler 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 Mar 6. pii: S0168-8278(21)00161-6. doi: 10.1016/j.jhep.2021.02.027. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 27, 2015)		 96
Original Estimated Enrollment  ICMJE
 (submitted: November 26, 2012)		 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:

  • Healthy male volunteers aged 18-30
  • BMI between 19-24 kg/m2
  • Non-smoker

Exclusion criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
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
  • SNF Swiss National Foundation
  • University of Lausanne
Investigators  ICMJE
Principal Investigator: Philipp Gerber, MD University Hospital Zurich, Endocrinology and Diabetology
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