Sugar Sweetened Beverages (SSB)- Effects on Metabolism

• ClinicalTrials.gov Identifier: NCT01733563
• Recruitment Status: Completed
• First Posted: November 27, 2012
• Last Update Posted: May 12, 2016
• Sponsor: University of Zurich
• Collaborators: SNF Swiss National Foundation; University of Lausanne
• Information provided by (Responsible Party): University of Zurich

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Metabolism	Procedure: Soft drink consumption	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Effects of Carbohydrate Containing Diets on Lipid Metabolism & Fatty Acid Oxidation in Healthy Young Men - a Randomized, Double-Blinded Study.
• Study Start Date: April 2013
• Actual Primary Completion Date: May 2016
• Actual Study Completion Date: May 2016

Arms and Interventions

Arm	Intervention/treatment
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	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	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	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	Procedure: Soft drink consumption

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Lipolysis [ Time Frame: After total 6 weeks dietary intervention ]
   Measurements using stable isotopes

Other Outcome Measures:

1. Waist/Hip Ratio [ Time Frame: After total 6 weeks dietary intervention ]
   Measurement waist/hip ratio using a nonstretchable band

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 30 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Switzerland

University Hospital Zurich, Endocrinology and Diabetology

Zurich, ZH, Switzerland, 8091

Sponsors and Collaborators

University of Zurich

SNF Swiss National Foundation

University of Lausanne

Investigators

• Principal Investigator: Philipp Gerber, MD; University Hospital Zurich, Endocrinology and Diabetology

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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]

• Responsible Party: University of Zurich
• ClinicalTrials.gov Identifier: NCT01733563
• Other Study ID Numbers: SSB-Effects on metabolism
• First Posted: November 27, 2012
• Last Update Posted: May 12, 2016
• Last Verified: May 2016

Keywords provided by University of Zurich:

sugar sweetened beverages; fructose; lipogenesis; beta-oxidation