Sugar Sweetened Beverages (SSB)- Effects on Metabolism

Metabolism Clinical Trial

Official title:

Effects of Carbohydrate Containing Diets on Lipid Metabolism & Fatty Acid Oxidation in Healthy Young Men - a Randomized, Double-Blinded Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01733563
• Other study ID #: SSB-Effects on metabolism
• Status: Recruiting
• Phase: N/A
• First received: November 9, 2012
• Last updated: October 27, 2015
• Start date: April 2013
• Est. completion date: December 2015

Study information

• Verified date: October 2015
• Source: University of Zurich
• Contact: Bettina Geidl, PhD
• Email: bettina.geidl[@]usz.ch
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Metabolism

Intervention

Procedure:
• Soft drink consumption

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Endocrinology and Diabetology	Zurich	ZH

Sponsors (3)

Lead Sponsor	Collaborator
University of Zurich	SNF Swiss National Foundation, University of Lausanne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Waist/Hip Ratio	Measurement waist/hip ratio using a nonstretchable band	After total 6 weeks dietary intervention	No
Primary	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	No
Secondary	Lipolysis	Measurements using stable isotopes	After total 6 weeks dietary intervention	No