Sugar Sweetened Beverages (SSB)- Effects on Metabolism

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Zurich
Sponsor:
Collaborators:
SNF Swiss National Foundation
University of Lausanne
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01733563
First received: November 9, 2012
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

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 eight weeks subjects will consume either fructose, glucose, sucrose or aspartame sweetened beverages or continue their usual drinking habits. During these eight weeks there will be different metabolic investigations using stable isotope tracers. First, fructose metabolism will be examined. Second, the rate of lipolysis and beta-oxidation will be determined. Third, 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. In addition, the effects of fructose consumption on the longterm memory will be assessed.


Condition Intervention
Metabolism
Procedure: Soft drink consumption

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Lipogenesis [ Time Frame: After total 6 weeks dietary intervention ] [ Designated as safety issue: No ]
    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:
  • Lipolysis [ Time Frame: After total 6 weeks dietary intervention ] [ Designated as safety issue: No ]
    Measurements using stable isotopes


Other Outcome Measures:
  • Waist/Hip Ratio [ Time Frame: After total 6 weeks dietary intervention ] [ Designated as safety issue: No ]
    Measurement waist/hip ratio using a nonstretchable band


Estimated Enrollment: 120
Study Start Date: April 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fructose sweetened beverage

Soft drink consumption:

Subjects have to drink a fructose sweetened beverage (3x 200ml per day, 13.3g fructose/100ml) during 8 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 8 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 8 weeks

Procedure: Soft drink consumption
Experimental: aspartame sweetened beverage

Soft drink consumption:

Subjects have to drink an aspartame sweetened beverage (3x 200ml per day, 66.6 mg aspartame/100ml) during 8 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 8 weeks

Procedure: Soft drink consumption

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01733563

Contacts
Contact: Bettina Geidl, PhD bettina.geidl@usz.ch
Contact: Kaspar Berneis, Prof MD kaspar.berneis@usz.ch

Locations
Switzerland
University Hospital Zurich, Endocrinology and Diabetology Recruiting
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
SNF Swiss National Foundation
University of Lausanne
Investigators
Principal Investigator: Kaspar Berneis, Prof MD University Hospital Zurich, Endocrinology and Diabetology
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01733563     History of Changes
Other Study ID Numbers: SSB-Effects on metabolism
Study First Received: November 9, 2012
Last Updated: June 27, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Zurich:
sugar sweetened beverages
fructose
lipogenesis
beta-oxidation

ClinicalTrials.gov processed this record on July 26, 2014